Latest Industry News & Trends
Market Scope provides comprehensive coverage of the ophthalmic market. Our news stories are a combination of public and proprietary content ranging from coverage of international meetings, surgeon survey results and trends, analysis of company financial reports and public medical registries, press releases, and interviews with executives. Register today to receive free weekly email updates, our top data chart, surgeon poll results, and much more. Locked content can be accessed through a subscription to our ophthalmic industry newsletters.
Breaking News
Visus Merges with Tenpoint, Will Advance Brimochol Once-Daily Presbyopia Drop Candidate
Visus Therapeutics and Tenpoint Therapeutics announced Dec. 12 the completion of a merger, with plans to advance Visus’ Brimochol PF, a once-daily eye drop candidate for presbyopia. The combined co...
Acelyrin’s Izokibep Misses Endpoints in Phase IIb/III Uveitis Trial
Acelyrin reported Dec. 10 that izokibep, an inhibitor of interleukin-17A, missed its endpoints in a Phase IIb/III trial in non-infectious, non-anterior uveitis. The company said it would drop izoki...
NurExone Reports Promising Preclinical Results in Restoring Vision After Optic Nerve Damage
NurExone Biologic, with offices in Canada and Israel, reported Dec. 6 findings of a preclinical study of its lead candidate, ExoPTEN, for repairing optic nerve damage. Researchers utilized a rodent...
Aflibercept Biosimilar Candidate from Celltrion Gains Positive CHMP Opinion
South Korea’s Celltrion announced Dec. 15 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued positive opinions recommending approval of three of i...
ViaLase Teams up with Moran Eye Center to Enhance Femto Laser Glaucoma Procedure
ViaLase of Aliso Viejo, California, reported Dec. 10 that it would partner with the John A. Moran Eye Center at the University of Utah to explore the effect of creating multiple channels in the tra...
SIFI Files for UK Approval of Akantior Drops for Acanthamoeba Keratitis
Italy’s SIFI reported Dec. 16 that it had filed a marketing authorization application with the UK’s Medicines and Healthcare Products Regulatory Agency for Akantior (polihexanide 0.08%) drops for t...
Nidek Launches NP-T Preloaded Toric IOL Injector Globally
Japanese ophthalmic company Nidek announced Dec. 2 that it had launched the NP-T preloaded toric intraocular lens (IOL) injection system globally. Previously, the injector had been available only i...
Nicox Reports First Sale of Zerviate in China by Partner Ocumension
France’s Nicox reported Dec. 4 that its partner Ocumension Therapeutics had made the first commercial sale of Zerviate (cetirizine ophthalmic solution) 0.24% in China. Zerviate is indicated for ocu...
2025-2026 Ophthalmic Meetings Calendar
Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.
Bausch + Lomb Acquires Elios Vision, Developer of Excimer Laser Trabeculostomy
Bausch + Lomb announced Dec. 11 that an affiliate had acquired Elios Vision, developer of the Elios excimer laser trabeculostomy procedure for glaucoma. No financial details were disclosed. Elios’ ...
Topcon Weighing Takeover Bids from Private Equity Firms, Bloomberg Reports
Topcon is considering takeover bids from suitors, including the private equity firms KKR & Co. and EQT AB, according to a report Dec. 10 from financial news outlet Bloomberg. The Tokyo-based ophtha...
ARPA-H Pledges $125 Million in Quest to Advance Whole Eye Transplants
The Advanced Research Projects Agency for Health (ARPA-H) announced Dec. 2 that it would pledge up to $125 million from its Transplantation of Human Eye Allografts (THEA) program to advance researc...
Zeiss Gains US Approval for MEL 90 Excimer Laser
Carl Zeiss Meditec gained US FDA approval on Dec. 4 for its MEL 90 excimer laser, the next-generation iteration of its MEL 80 for LASIK surgery. The MEL 90’s US labeling is for correction of myopia...
US FDA Gives Green Light to Phase I/II Trial of Sumitomo Retinal Cell Implant for RP
Japan’s Sumitomo Pharma announced Nov. 29 that the US FDA had cleared its investigational new drug (IND) application for a Phase I/II trial of its allogeneic retinal sheet derived from induced plur...
US FDA Grants Orphan Drug Status to AAVantgarde Bio’s Gene Therapy Candidate for Usher1B RP
Italy’s AAVantgarde Bio announced Dec. 2 the US FDA had granted orphan drug designation to its lead gene therapy candidate, AAVB-081, targeting Usher syndrome type 1B retinitis pigmentosa. Orphan d...
Medvisis to Market Clobetasol Drops in Switzerland, Liechtenstein, Under License with Formosa
Swiss company Medvisis has obtained exclusive rights to market clobetasol propionate eye drops in Switzerland and Liechtenstein for inflammation and pain following ocular surgery under a license ag...
Kyung-Ah Kim, PhD, Named President, CEO of Samsung Bioepis
South Korea’s Samsung Bioepis announced Nov. 27 that Kyung-Ah Kim, PhD, has been appointed president and chief executive officer. Kim had been serving as executive vice president and development di...
Ophtec Receives CE Marking for Artiplus Phakic IOL, Targets Young Presbyopes
Dutch company Ophtec announced Nov. 18 that it had gained CE Mark approval for its Artiplus phakic intraocular lens (IOL). The company said the lens offered a solution for relatively young presbyop...
Outlook’s Lytenava Misses Endpoint vs. Ranibizumab in Topline Results
Outlook Therapeutics reported Nov. 27 that its ophthalmic bevacizumab candidate Lytenava (ONS-5010) did not meet its non-inferiority endpoint in topline results from the NORSE EIGHT trial vs. ranib...
US FDA Rejects sNDA for Izervay Seeking Every-Other-Month Dosing
Japan’s Astellas Pharma announced Nov. 19 that the US FDA had issued a complete response letter rejecting its supplemental new drug application (sNDA) for Izervay seeking to expand the drug’s label...
Konan Medical Launches ObjectiveField Perimeter in US
Konan Medical has launched its ObjectiveField visual field analyzer in the US. The ObjectiveField is an objective perimeter designed to detect visual field abnormalities using pupillary responses. ...
EU Grants Orphan Drug Status to Ocugen’s Gene Therapy Candidate for ABCA4-Associated Retinopathies
Ocugen announced Nov. 20 that the European Medicines Agency had granted orphan medicinal product status for OCU410ST, a gene therapy candidate targeting ABCA4-associated retinopathies, including St...
Avant, Ainnova Advancing Low-Cost Retinal Camera with AI Screening Software
Nevada-based Avant Technologies and Ainnova Tech, of Houston, Texas, announced Nov. 20 that the two companies would advance Ainnova’s proprietary low-cost retinal camera packaged with the Vision AI...
MACs Finalize Coverage for Standalone and Combo MIGS Procedures
Five Medicare administrative contractors have issued their final coverage policies for minimally invasive glaucoma surgery, or MIGS, along with more technical billing and coding documents. The poli...
Harrow Lowers Price of Drugs through GoodRx Partnership, Price Cuts
Harrow, of Nashville, Tennessee reported Nov. 13 that it had entered into a partnership with GoodRx to provide patients for whom insurance is not a viable option a cash-pay alternative. Harrow prod...
GenSight Submits Updated Data on Lumevoq to Restart Early Access Program in France
Paris-based GenSight Biologics announced Nov. 13 that it had submitted an updated regulatory file for Lumevoq, its gene therapy candidate for Leber hereditary optic neuropathy (LHON), to French reg...
US FDA Clears Tixel i Dry Eye and MGD Treatment Device from Novoxel
Israel’s Novoxel announced Nov. 19 that the US FDA had granted 510(k) clearance to the Tixel i treatment device for evaporative dry eye and meibomian gland dysfunction. The company said the device ...
Nicox Chooses Higher Dose of NCX 470 to Advance in Phase III Glaucoma Trials
France’s Nicox announced Nov. 19 that it had chosen the higher dose of NCX 470 ophthalmic solution to advance in the Phase III Mont Blanc trial in glaucoma. The company said both doses tested—0.065...
Atsena Licenses LCA1 Gene Therapy Candidate to Nippon Shinyaku for US, Japan
Atsena Therapeutics announced Nov. 13 that it had granted exclusive commercial rights for its Leber congenital amaurosis type 1 (LCA1) gene therapy candidate ATSN-101 to Nippon Shinyaku in the US a...
US FDA Grants Rare Pediatric, Fast Track Status to Alkeus’ Stargardt Candidate
Alkeus Pharmaceuticals announced Nov. 18 that the US FDA had granted rare pediatric disease and fast track designations to gildeuretinol (ALK-001), its oral therapy candidate for Stargardt disease....
CMS Cuts Ophthalmologists’ Procedure Fees, While Raising ASC, HOPD Facility Fees
The Centers for Medicare and Medicaid Services (CMS) published on Nov. 1 the final schedule of Medicare reimbursement fees for physicians in 2025. It also released its facility fee payments for ASC...
Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron
Amgen has launched its Eylea biosimilar, Pavblu (aflibercept-ayyh), after a victory in October in its patent fight with Regeneron. Fierce Pharma reported that a trio of US circuit judges on Oct. 22...
Harrow’s ImprimisRx Unit Gets $34.9 Million Trademark Infringement Verdict
Harrow’s ImprimisRx subsidiary received a $34.9 million verdict on Nov. 20, 2024, in a trademark infringement lawsuit against OSRX Pharmaceuticals, of Missoula, Montana. OSRX is an affiliate of Ocu...
Q3-2024 Ophthalmic Revenue Roundup for Immunocore, Harrow, Tarsus, Lumibird, and Ocular Therapeutix
UK-headquartered Immunocore reported Nov. 6 that its Q3-2024 net revenue from Kimmtrak (tebentafusp) was $80.2 million, a 28 percent increase over $62.6 million in Q3-2023. Regionally, Kimmtrak net...
Samsung Bioepis, Biogen Gain EU Approval for Aflibercept Biosimilar Known as Opuviz
Korea’s Samsung Bioepis and Biogen, of Cambridge, Massachusetts, announced Nov. 18 that the European Commission had granted marketing authorization for Opuviz (aflibercept-yszy), an Eylea biosimila...
US FDA Accepts NDA for Aldeyra’s Reproxalap in Dry Eye
Aldeyra Therapeutics announced Nov. 18 that the US FDA had accepted for review the company’s resubmitted new drug application (NDA) for topical ocular reproxalap for dry eye. The FDA assigned a Pre...
MeiraGTx to Submit UK Marketing Application for LCA4 Candidate Under ‘Exceptional Circumstances’
MeiraGTx, with offices in London and New York, announced Nov. 13 that it would submit a marketing authorization application in the UK under “exceptional circumstances” for AAV-AIPL1, its gene thera...
Eyenovia Scraps Phase III Study of Low-Dose Atropine in Myopia After Endpoint Missed
Eyenovia reported Nov. 15 that it would scrap the Phase III CHAPERONE trial of low-dose atropine in pediatric myopia after an independent data review committee determined that the trial is not meet...
Sandoz Gains EU Approval for its Aflibercept Biosimilar Known as Afqlir
Swiss drugmakerSandoz announced Nov. 15 that the European Commission had granted marketing authorization for Afqlir (aflibercept), an Eylea biosimilar. Afqlir, available as a 2 mg vial kit and pre-...
Q3-2024 Ophthalmic Revenue Roundup for Alcon, Hoya, RxSight, Sight Sciences, and Iridex
Alcon reported Nov. 12 that its Q3-2024 net sales totaled $2.4 billion, a 6 percent increase over $2.3 billion in Q3-2023. Surgical net sales for implantables, consumables, and equipment/other were...
Kalaris Will Merge with AlloVir and Advance Candidate for Exudative Retinal Disease
Kalaris Therapeutics announced Nov. 8 that it would merge with biotech company AlloVir in an all-stock transaction to advance Kalaris’ next-generation anti-VEGF candidate TH103 for exudative retina...
Advancium Signs Option to License Retinoblastoma Candidate from Aileron
Aileron Therapeutics and Advancium Health Network announced Oct. 31 an exclusive option agreement for Advancium to acquire ALRN-6924, a clinical-stage oncology agent developed by Aileron prior to i...
Arctic Vision Licenses Chinese Rights for Xipere to Santen for $85 Million
Clearside Biomedical’s Asia-Pacific partner, Arctic Vision, announced Nov. 7 that it had licensed Chinese commercialization rights for ARVN001, marketed in the US as Xipere, to Santen Pharmaceutica...
US FDA Grants Fast Track Designation to Feliqs’ ROP Candidate
Japanese biopharmaceutical company Feliqs announced Nov. 1 that the US FDA had granted its lead asset, FLQ-101, fast track designation for the prevention of retinopathy of prematurity (ROP). FLQ-10...
US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD
LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobiomodulation system for treatment of patients with dry age-related macul...
Q3-2024 Ophthalmic Revenue Roundup for AbbVie, Apellis, Glaukos, STAAR, and Lensar
AbbVie, of North Chicago, Illinois, reported Oct. 30 that its Q3-2024 eye care net revenue was $525 million, a 13.5 percent decline (-11.2 percent cc) from $605 million in Q3-2023. Restasis revenue...
NovaBay Accepts Higher Offer from PRN to Purchase Assets
NovaBay reported Nov. 6 that it had accepted a higher offer from PRN Physician Recommended Nutriceuticals, LLC, which revised its bid for NovaBay’s Avenova product line after a competing overture f...
US FDA Asks for Added Data on Neurotech MacTel Candidate, Pushes Back PDUFA Date
Neurotech Pharmaceuticals announced Nov. 8 that it had submitted additional data requested by the US FDA to support its biologic license application (BLA) for NT-501, an encapsulated cell therapy i...
US FDA Gives Green Light to Phase I Trial of HuidaGene’s CRISPR RNA-Editing Candidate for Wet AMD
HuidaGene Therapeutics announced Nov. 4 that the US FDA had cleared its investigational new drug (IND) application for a Phase I trial of HG202, a gene therapy candidate targeting wet age-related m...
DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal
Taiwan-based Formosa Pharmaceuticals announced Oct. 31 that it had entered into an exclusive licensing agreement with DÁVI Farmacêutica, of Portugal, for the rights there to market clobetasol propi...
Tarsus Appoints Elizabeth Yeu, MD, as Chief Medical Officer
Tarsus Pharmaceuticals, maker of Xdemvy for Demodex blepharitis, announced Nov. 5 that it had appointed Elizabeth Yeu, MD, as chief medical officer. Yeu had served as Tarsus’ chief medical advisor ...
Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA
Japan’s Astellas Pharma announced Oct. 28 that it had withdrawn its marketing authorization application in the EU for avacincaptad pegol, a complement-5 inhibitor targeting geographic atrophy (GA) ...
Q3-2024 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Novartis
Regeneron of Tarrytown, New York, reported Oct. 31 that its Q3-2024 US revenue for Eylea (aflibercept) 2 mg and Eylea HD (a higher dose of aflibercept at 8 mg) was $1.54 billion, a 3 percent increa...
Vabysmo Improved Vision in Underrepresented Populations with DME in Elevatum Study
Genentech, a member of the Roche Group, announced Oct. 18 positive topline one-year results from the postmarket Elevatum study evaluating Vabysmo (faricimab-svoa) for the treatment of diabetic macu...
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH
Michelle E. Tarver, MD, PhD, has been named director of the FDA’s Center for Devices and Radiological Health (CDRH), after serving as acting director since July 2024. She is a board-certified ophth...
NovaBay Receives Higher Asset Purchase Bid from RVL-Affiliated Company
NovaBay reported Oct. 29 that it had received a better offer for its assets than the one it had accepted from PRN Physician Recommended Nutriceuticals, LLC. NovaBay’s board determined that the unso...
Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III
Alkeus Pharmaceuticals reported positive topline results on Oct. 23 from the Phase III SAGA trial of gildeuretinol acetate (ALK-001), a once-daily oral therapy candidate targeting geographic atroph...
RevOpsis Awarded $1.8 Million NEI Grant to Advance Retinal Candidate RO-104
RevOpsis Therapeutics announced Oct. 15 that it had been awarded a Small Business Innovation Research grant of $1.8 million from the National Eye Institute (NEI) to advance lead asset RO-104 for ex...
Korean Companies GC Biopharma, Novelty Nobility to Collaborate on GA Drug Discovery
South Korean companies GC Biopharma and Novelty Nobility announced Oct. 28 that they would jointly research and develop a novel treatment candidate for geographic atrophy (GA). The companies said a...
Pine Pharmaceuticals Stops Compounding IVT Avastin, Creating Concerns Over Shortage
Pine Pharmaceuticals, of Tonawanda, New York, stopped repackaging Avastin (bevacizumab) for ophthalmic use in October 2024, according to the American Academy of Ophthalmology and American Society o...
Q3-2024 Ophthalmic Revenue Roundup for Roche and J&J Vision
Swiss company Roche reported Oct. 23 that Q3-2024 Vabysmo sales were CHF 1 billion ($1.15 billion, converted on Oct. 23, 2024), a 59 percent increase over CHF 656 million in Q3-2023. The company sa...
US FDA Accepts NDA For Lenz’ Presbyopia Drop Candidate
Lenz Therapeutics announced Oct. 21 that the US FDA had accepted its new drug application (NDA) for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. The FDA assigned a Pre...
Ocuphire Pharma Acquires Opus Genetics, Will Operate Under Opus Name
Ocuphire Pharma announced Oct. 22 that it would acquire Opus Genetics in an all-stock transaction. The combined company will operate under the Opus name and will trade on the Nasdaq under the ticke...
ARPA-H Seeks Proposals for Tear Duct-Based Diagnostic System, Plus Custom Dosing Platform
ARPA-H announced Oct. 18 that it had launched a new program to develop a tear-based biomarker measurement system that can be inserted into the tear duct to provide continuous health monitoring, pai...
Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients
Science Corporation, of Alameda, California, reported Oct. 22 preliminary results that showed its Prima retinal implant allowed for functional vision in patients who had lost their central visual f...
Grifols, BARDA Partner on Ocular Immunoglobulin Drops for Sulfur Mustard Exposure
Barcelona-basedGrifols reported Oct. 22 that it is partnering with the US government’s BARDA to test ocular surface immunoglobulin (OSIG) eye drops for their ability to treat ocular damage from sul...
Corza Launches Onatec Ophthalmic Microsurgical Suture Portfolio
Corza Medical, of Westwood, Massachusetts, reported Oct. 21 that it had launched its Onatec ophthalmic microsurgical suture portfolio of needles and suture material. The company said Onatec needles...
Bausch + Lomb Gains US FDA Approval of enVista Envy Trifocal IOL
Bausch + Lomb reported Oct. 14 that the US FDA had approved itsenVista Envy trifocal intraocular lens. The lens is available on a limited basis in the US and will be launched more broadly in 2025. ...
Spinogenix Unveils Glaucoma Program to Evaluate Once-Daily Neuroprotective Pill
Los Angeles-based Spinogenix reported Oct. 16 that it was launching a program to evaluate SPG302 as a potential neuroprotective therapeutic for glaucoma. Spinogenix describes SPG302 as a once-a-day...
Eyenuk, AAO Collaborate to Offer AI-Driven DR Screening for Underserved Patients in Delaware
Eyenuk and the American Academy of Ophthalmology (AAO) reported Oct. 16 that they had teamed up under the AAO’s EyeCare America program to provide eye disease screening for underserved communities ...
US FDA Grants 510(k) Clearance to Flex Module for Heidelberg Spectralis OCT
Heidelberg Engineering announced Oct. 14 that the US FDA had granted 510(k) clearance to its Flex Module for the Spectralis diagnostic imaging platform. The Flex Module mounts the Spectralis to a m...
Orasis Licenses Qlosi Presbyopia Drops to Optus in Korea for $18 Million, Plus Royalties
Orasis Pharmaceuticals announced Oct. 16 that it had licensed its Qlosi presbyopia drops to Optus Pharmaceuticals for the Korean market. Under the deal, Optus will pay upfront and milestone payment...
Nicox and Soleus Sign $16.5 Million Deal for Vyzulta Royalties, Equity Financing
France’s Nicox announced Oct. 14 a deal with Soleus Capital under which Soleus will acquire Nicox’ royalties from the glaucoma treatment Vyzulta for $15 million, while providing $1.5 million in equ...
Cure Blindness Project Expands Sight-Saving Care to Six New Countries
Cure Blindness Project is expanding to six new countries—Burundi, Democratic Republic of the Congo, Liberia, Pakistan, Paraguay, and Zambia, the charity reported Oct. 10. Paraguay marksthe charity’...
Lensar Marks 1 Million Procedures Using its Femtosecond Cataract Lasers
Lensar reported Oct. 8 that surgeons had performed more than 1 million procedures using its Lensar femtosecond cataract systems. The Orlando, Florida, company introduced its original Lensar Laser S...
EU Grants Orphan Drug Status to Theriva’s Retinoblastoma Candidate
Theriva Biologics, of Rockville, Maryland, announced Oct. 16 that the European Commission had granted orphan medicinal product designation for VCN-01, its treatment candidate for retinoblastoma. VC...
Aldeyra Resubmits NDA for Reproxalap in Dry Eye
Aldeyra Therapeutics announced Oct. 3 that it had resubmitted its new drug application (NDA) to the US FDA for topical ocular reproxalap in dry eye. The US FDA issued a complete response letter in ...
Nanoscope Plans to Submit BLA for Optogenetic RP Candidate in Q1-2025
Nanoscope Therapeutics announced Oct. 10 that it had met with the US FDA regarding MCO-010, an ambient-light-activatable optogenetic monotherapy to restore vision in patients with advanced retiniti...
FTC Sends More Than $1.1 Million to Consumers Misled by LCA-Vision Ads
The Federal Trade Commission (FTC) announced Oct. 3 that it was sending more than $1.1 million in settlement payments to consumers who were misled by deceptive bait-and-switch advertising by LCA-Vi...
Rayner Begins US Study of RayOne Galaxy Trifocal Spiral IOL
UK-based Rayner reported Oct. 1 that the first RayOne Galaxy lenses had been implanted in the US as part of an FDA investigational device exemption (IDE) study. Rayner describes the Galaxy, a trifo...
US FDA Removes Clinical Hold on Ocugen’s IND for OCU200 in DME
Ocugen announced Oct. 9 that the US FDA had lifted its clinical hold on the investigational new drug (IND) application for a Phase I trial of OCU200, a recombinant fusion protein consisting of tums...
Beyeonics One Introduces ‘Invisible Light’ Infrared Illumination
Israel’s Beyeonics Vision announced Oct. 8 that it had incorporated “invisible light” technology, based on infrared night vision, into the Beyeonics One surgical visualization system. Beyeonics sai...
iCare Launches ST500 Slit Lamp Mounted Rebound Tonometer
Finland’s iCare, a subsidiary of Revenio Group, has launched its iCare ST500 rebound tonometer that can be attached to a slit lamp. The device gained US FDA 510(k) clearance on Sept. 27. The compan...
Iridex Appoints Patrick Mercer as Chief Executive Officer
Iridex reported Oct. 3 that it had appointed Patrick Mercer as chief executive officer, to go along with his role as president, effective Oct. 1. Mercer had also served as the company’s chief opera...
Opthea Appoints Parisa Zamiri, MD, PhD, as Chief Medical Officer
Australian drug developer Opthea announced Oct. 8 that it had appointed Parisa Zamiri, MD, PhD, as chief medical officer. Zamiri, an ophthalmologist, has clinical experience in medical retina, immu...
Oak Hill Bio Promotes Josh Distler, JD, to Chief Executive Officer
Oak Hill Bio, of Cambridge, Massachusetts, announced Oct. 7 that it had promoted Josh Distler, JD, to chief executive officer. Distler is a co-founder of Oak Hill and previously served as the compa...
Harrow Relaunches Triesence Ophthalmic Corticosteroid in US
Nashville, Tennessee-based Harrow reported Oct. 3 that it had relaunchedTriesence (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative‑free synthetic corticosteroid, in the US. ...
Eyenovia Launches Clobetasol Drops for Postoperative Pain, Inflammation
Eyenovia announced Sept. 26 the US launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, known as Clobetasol, for postoperative inflammation and pain following oc...
EU Regulators Approve Vevizye from Novaliq; Théa Will Commercialize Dry Eye Drop
Germany’s Novaliq announced Oct. 2 that the European Commission had approved its dry eye treatment Vevizye (cyclosporine ophthalmic solution) 0.1%. The product is indicated for the treatment of mod...
Zeiss Invests $24 Million to Expand Production Site in Chesterfield, Missouri
German company Carl Zeiss Meditec opened a new state-of-the-art research and production facility on Oct. 1 in Chesterfield, Missouri, expanding its footprint in the city, which is part of the St. L...
Ross Segan, MD, MBA, FACS, Takes Helm of FDA’s OPEQ
Ross Segan, MD, MBA, FACS, has becomedirector of the US FDA’s Office of Product Evaluation and Quality (OPEQ). The office, part of FDA’s Center for Devices and Radiological Health (CDRH), oversees ...
NEI Researchers Identify Protein That Clears Cataracts in Animals
Researchers at the National Eye Institute (NEI), working with counterparts in China, have discovered a reversible cataract response in hibernating squirrels that may point toward a nonsurgical trea...
SIFI Launches Akantior Drops for Acanthamoeba Keratitis in Germany
Italy’s SIFI announced Sept. 30 the launch in Germany of its Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in patients 12 a...
Aurion Launches Vyznova Corneal Cell Therapy in Japan
Aurion Biotech announced Sept. 24 that it had launched Vyznova (neltependocel), a cell therapy for bullous keratopathy of the cornea, in Japan. Japanese regulators approved Vyznova in March 2023. T...
Boehringer Ingelheim to Advance Surrozen’s Bi-specific Antibody in Retinal Disease
Surrozen announced Sept. 24 that development partner Boehringer Ingelheim will advance SZN-413, a bi-specific antibody targeting retinal vascular disease. The milestone triggers a $10 million payme...
Switzerland’s Rejuveron Life Sciences Rebrands as Centenara Labs
Switzerland’s Rejuveron Life Sciences announced Sept. 19 that it had rebranded as Centenara Labs. The company develops and invests in therapeutic candidates to promote healthy aging. Centenara said...
Nanoscope Licenses Optogenetic Technology from Max Planck Innovation
Nanoscope Therapeutics announced Sept. 30 that it had acquired a license for CatCh optogenetic technology from Max Planck Innovation, the technology transfer arm of the Max Planck Society. Financia...
US FDA Grants Fast Track Designation to Priovant’s Uveitis Candidate
Priovant Therapeutics, of Durham, North Carolina, reported Sept. 23 that the US FDA had granted fast track designation for brepocitinib in non-infectious intermediate or posterior uveitis or panuve...
US FDA Grants Orphan Drug Status to Atsena’s XLRS Gene Therapy Candidate
Atsena Therapeutics announced Sept. 17 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s orphan drug designation. The candidate was granted rare...
Eyconis Appoints Mark J. Bachleda, PharmD, MBA, as CEO
Eyconis announced Sept. 19 that it had appointed Mark J. Bachleda, PharmD, MBA, as chief executive officer and a member of its board of directors. Bachleda has served in executive leadership roles ...
Luxa Biotechnology Appoints Keith Dionne, PhD, as CEO
Luxa Biotechnology announced Oct. 1 that it had appointed Keith Dionne, PhD, as chief executive officer. Luxa, of Fort Lee, New Jersey, is advancing RPESC-RPE-4W, a cell product derived from adult ...
Zeiss Announces Broad US Rollout of Micor 700 for Phaco-less Cataract Surgery
Carl Zeiss Meditec reported Sept. 26 that it had begun broad US distribution of the Micor 700, the first hand-held device to extract a crystalline lens in cataract surgery without the need for ultr...
AbbVie Withdraws EU Marketing Application for Durysta
Europe’s Committee for Medicinal Products for Human Use (CHMP) announced Sept. 19 that AbbVie had withdrawn its marketing authorization application for the sustained-release glaucoma implant Duryst...
Nicox, Glaukos Sign Research and Option Agreement for Glaucoma Candidate
France’s Nicox announced Sept. 23 that it had signed an exclusive research and license option agreement with Glaukos for NCX 1728, Nicox’s novel nitric oxide (NO)-donating phosphodiesterase-5 (PDE5...
Tepezza Receives Approval in Japan to Treat Active Thyroid Eye Disease
Amgen reported Sept. 24 that Tepezza had gained approval in Japan for the treatment of active or high clinical activity score thyroid eye disease (TED). The Thousand Oaks, California, company said ...
Amgen’s Pavblu is Fifth Aflibercept Biosimilar to Gain US Approval in 2024
The FDA has approved Amgen’s Pavblu (aflibercept-ayyh), making it the fifth Eylea biosimilar to reach the milestone in the US in 2024. FDA records show Pavblu was approved Aug. 23. Labeling shows i...
Europe’s CHMP Recommends Two Aflibercept Biosimilars for Approval
Europe’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions on Sept. 19 for two new aflibercept (Eylea) biosimilars—Afqlir from Swiss drugmaker Sandoz and Opuviz, which ...
Microsurgical Technology (MST) to Commercialize Vista Vitrectomy Products
Microsurgical Technology (MST) announced Sept. 17 that it had partnered with Vista Ophthalmics to commercialize Vista’s products—the Vista 1-Step vitrectomy probe and the Vista IS for maintaining t...
AAVantgarde Bio Appoints Jayashree Sahni, MD, as Chief Medical Officer
Italy’s AAVantgarde Bio announced Sept. 9 that it had appointed Jayashree Sahni, MD, FRCOphth, EMBA, as chief medical officer. Sahni, a retina specialist, was senior global program clinical head at...
Harrow to Add Nearly 150 Jobs as it Continues Expanding in Nashville
Harrow reported Sept. 25 that it is creating nearly 150 new jobs as it expands its corporate headquarters in Nashville, Tennessee. The move follows the company increasing its total leased space in ...
Bausch + Lomb Explores Sale to Separate from Bausch Health
Bausch + Lomb is working with Goldman Sachs to explore a sale of the company, the Financial Times reported Sept. 14, with private equity the most likely buyer. The move is being evaluated as a way ...
Apellis Receives Negative CHMP Opinion on Pegcetacoplan in GA After Re-examination
Apellis Pharmaceuticals announced Sept. 20 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had reaffirmed its June 2024 negative opinion on the company’s ...
NYU Langone Hails Recovery of Man Over a Year after Landmark Whole Eye Transplant
A surgical team at NYU Langone Health performed the world’s first whole eye and partial-face transplant in May 2023 for Aaron James, who had survived a high-voltage electrical accident at work. Ove...
NovaBay to Sell Avenova Products for $9.5 Million as Part of Dissolution Plan
NovaBay Pharmaceuticals has agreed to sell its Avenova products to PRNPhysician Recommended Nutriceuticals for $9.5 million in cash, the companies announced Sept. 20. The deal is expected to close ...
US FDA Warns Regener-Eyes Maker Over Plant Conditions, Unapproved Products
The US FDA has sent a warning letter to Regenerative Processing Plant in Palm Harbor, Florida, finding fault with its manufacturing processes and raising concerns that its eye drop products may sti...
Indian Regulators Approve First Ophthalmic AI Software—Medios DR from Remidio
India’s Remidio announced Sept. 13 that regulators there had approved its Medios DR software for autonomous detection of diabetic retinopathy (DR). Medios DR becomes the first ophthalmic artificial...
Nicox Reports that Ocumension Has Gained Approval for Zerviate in China
France’s Nicox announced Sept. 18 that partner Ocumension Therapeutics had received regulatory approval in China to commercialize Nicox’ Zerviate (cetirizine ophthalmic solution) 0.24% for ocular i...
Ripple, AbbVie to Collaborate on Fully Biodegradable Bimatoprost Implant for Glaucoma
Ripple Therapeutics, of Toronto, Canada, announced Sept. 17 that it had signed a collaboration agreement with AbbVie to develop RTC-620, a fully biodegradable sustained-release intracameral bimatop...
Zeiss Plans to Use Creal's Technology to Reimagine Refractive Exams
Zeiss will integrate Swiss company Creal’s light field display technology into its refractive diagnostic equipment under a collaboration agreement, the two companies reported Sept. 10. Creal descri...
Oculus Debuts Frequency Doubling Perimetry with Easyfield VR
Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset, along with standard automated perimetry. The German ophthalmic diagnosti...
OcuDyne Reports Positive Pilot Study Results Using Ophthalmic Artery Angioplasty in GA
OcuDyne, of Brooklyn Park, Minnesota, reported Sept. 9 that it had successfully completed a pilot study using its Optic System to perform ophthalmic artery angioplasty in patients with geographic a...
US FDA Gives Go-Ahead to Trial of BlueRock’s Cell Therapy Candidate for Photoreceptor Diseases
Bayer subsidiary BlueRock Therapeutics announced Sept. 3 that the US FDA had cleared its investigational new drug application for a Phase I/IIa trial of OpCT-001, an induced pluripotent stem cell (...
iStar Medical Appoints Richard Beckman, MD, as Chief Medical Officer
Belgium’s iStar Medical announced Sept. 4 that it had appointed Richard Beckman, MD, as chief medical officer and member of the company’s board. Beckman most recently served as CMO of Adverum Biote...
US FDA Grants Orphan Drug Status to Skyline’s Gene Therapy Candidate for RP
China’s Skyline Therapeutics announced Sept. 3 that the US FDA had granted orphan drug designation to SKG1108, an intravitreal gene therapy candidate for retinitis pigmentosa (RP). SKG1108 is a rec...
Belite Bio Appoints Hendrik P.N. Scholl, MD, MA, as Chief Medical Officer
Belite Bio announced Sept. 1 that it had appointed Hendrik P.N. Scholl, MD, MA, as chief medical officer, effective immediately. Scholl specializes in inherited retinal and macular dystrophies, and...
BioCryst Appoints Donald Fong, MD, as Chief Medical Officer
BioCryst Pharmaceuticals, of Durham, North Carolina, announced Sept. 5 that it had appointed Donald S. Fong, MD, MPH, as the company’s new chief medical officer, effective immediately. Fong joined ...
Carl Zeiss Meditec Introduces Hyperopia Treatment Using Lenticule Extraction
German company Carl Zeiss Meditec reported Aug. 24 that it had become the first medical device manufacturer to introduce in the CE market the treatment of hyperopia using lenticule extraction. This...
Injectsense Completes First Human Implantation of its Ultraminiaturized IOP Sensor
Injectsense, of Emeryville, California, announced Aug. 27 that it had implanted its first ultraminiature wireless sensor for measuring intraocular pressure (IOP). Glaucoma specialist Juan Mura, MD,...
Light Control May Prevent Eye Damage in Premature Infants, Study Shows
A study in mice at the Science of Light Center at Cincinnati Children’s shows that lighting conditions can change how newborn eyes develop, with darkness fostering the development of more rods, the...
Tern Therapeutics Launches with $15 Million Financing and Pipeline in CLN2 Batten Disease
Tern Therapeutics announced its launch Aug. 27, along with closing of a $15 million financing. The company also reported that it had licensed gene therapy candidates RGX-381 and RGX-181 (now design...
NovaSight Gains Approval in China for CureSight System for Amblyopia
Israel-based NovaSight reported Sept. 4 that its CureSight eye-tracking system for amblyopia in children had gained approval from Chinese regulators, expanding the device’s availability to the thre...
Visionix Unveils its VX 610 Automated Fundus Camera
Visionix USA has announced the launch of its VX 610 non-mydriatic automated fundus camera. The VX 610 boasts a range of automated features, including auto alignment, auto focus, and auto capture, w...
Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error
Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...
Health Canada Gives Green Light to Phase III Trial of Ocugen’s Gene Therapy Candidate for RP
Ocugen announced Aug. 26 that Health Canada had cleared the way for a Canadian Phase III trial of OCU400, a modifier gene therapy candidate for retinitis pigmentosa (RP). Ocugen, of Malvern, Pennsy...
Rayner to Roll Out First Spiral IOL at 2024 ESCRS Congress
UK-based Rayner reported Aug. 26 that it was set to launch the first spiral intraocular lens models—the RayOne Galaxy and Galaxy Toric—at the 2024 ESCRS Congress, set for Sept. 6-10 in Barcelona, S...
Alcon Reports Q2-2024 Net Sales of $2.5 Billion
Alcon reported Aug. 20 that its Q2-2024 net sales totaled $2.5 billion, a record quarter for the company and a 3 percent increase (+6 percent cc) over $2.4 billion in Q2-2023. Surgical net sales fo...
European Commission Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis
Italy’s SIFI announced Aug. 26 that the European Commission had approved Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in p...
Precision Lens and Estate of Paul Ehlen to Pay US $12M over Kickbacks
Minnesota-based ophthalmic distributor Precision Lens and the estate of co-founder Paul Ehlen have agreed to pay the US government $12 million to resolve a case involving kickback payments in vario...
Six States Sue Regeneron over Eylea Drug Price Reporting
The attorneys general for Colorado, Georgia, Michigan, North Carolina, Texas, and Washington have filed suit in federal district court against Regeneron Pharmaceuticals, claiming the drugmaker infl...
Revenio’s iCare Subsidiary Acquires AI Screening Company Thirona Retina
Finland’s Revenio Group announced Aug. 20 that its iCare subsidiary had assumed ownership of the Dutch artificial intelligence (AI) software company Thirona Retina. iCare had made a minority invest...
Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results
A new analysis of 2008 clinical study data has given a boost to Livionex’ topical drop candidate for cataracts, the John Moran Eye Center reported Aug. 16. The drop, called C-KAD, is a formulation ...
SriniVas Sadda, MD, Named Doheny Endowed Chair, Capping Year of New Roles
The Doheny Eye Institute announced Aug. 14 that SriniVas Sadda, MD, had been named the A. Ray Irvine Jr., MD, Endowed Chair. He also was recently named president of the Association for Research in ...
Visiox to Merge with Ocuvex to Advance Candidates for Glaucoma, Postsurgical Pain and Inflammation
Visiox Pharmaceuticals announced Aug. 19 that it had agreed to merge with Ocuvex Therapeutics, a privately held company in New Hyde Park, New York. A Visiox news release said Ocuvex has a pipeline ...
EMA Accepts Marketing Application for Aflibercept (Eylea) Biosimilar from Alvotech
Biosimilar company Alvotech and its partner Advanz Pharma announced Aug. 15 that the European Medicines Agency (EMA) had accepted a marketing authorization application for AVT06, Alvotech’s propose...
Acelyrin Shifts Pipeline to Focus on TED Candidate, Lays Off About 40 Workers
Acelyrin reported Aug. 13 that it would reduce its workforce and shift its pipeline strategy to prioritize lonigutamab, its candidate for thyroid eye disease (TED). The announcement came amid posit...
US FDA Grants Tentative Approval to Generic Brimonidine Tartrate Ophthalmic Solution (Lumify) from Lupin
Indian drugmaker Lupin announced Aug. 14 that it had received tentative approval from the US FDA for its abbreviated new drug application for brimonidine tartrate ophthalmic solution 0.025%, a gene...
US FDA Grants Rare Pediatric Disease Designation to Atsena’s X-Linked Retinoschisis Gene Therapy Candidate
Atsena Therapeutics announced Aug. 14 that ATSN-201, its gene therapy candidate for X-linked retinoschisis (XLRS), had received the US FDA’s rare pediatric disease designation. XLRS is a monogenic ...
US FDA Grants Rare Pediatric Disease Designation to Opus’ LCA5 Gene Therapy Candidate
Opus Genetics announced Aug. 20 that OPGx-LCA5, its gene therapy candidate for Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene, had received the US FDA’s rare p...
Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser
Eyenovia announced in its Q2-2024 financial results that it planned to seek marketing clearance for an advanced Gen-2 Optejet microdoser. Eyenovia, of New York, said production was expected to begi...
SalioGen Therapeutics Appoints Kali Stasi, MD, PhD, as Chief Medical Officer
SalioGen Therapeutics announced Aug. 19 that it had appointed Kalliopi “Kali” Stasi, MD, PhD, as chief medical officer. SalioGen said Stasi will be responsible for bringing the company’s SGT-1001, ...
Ocumension Acquires Rights to Alcon Eye Drops in Exchange for 16.7 Percent Equity Stake
China’s Ocumension Therapeutics announced Aug. 13 that it would acquire or secure Chinese rights to a portfolio of Alcon dry eye treatments and procedural drops. In exchange, Ocumension will issue ...
Q2-2024 Ophthalmic Revenue Roundup for AbbVie, Carl Zeiss Meditec, Amgen, STAAR, Astellas, Immunocore, Tarsus, Biogen, Lensar, and Iridex
AbbVie, of North Chicago, Illinois, reported July 25 that Q2-2024 net revenue for its eye care products totaled $533 million, a 13.3 percent decline (-10.9 percent cc) from $617 million in Q2-2023....
US FDA Approves Aflibercept (Eylea) Biosimilar from Sandoz
Swiss drugmaker Sandoz announced Aug. 12 that the US FDA had approved Enzeevu, an aflibercept (Eylea) biosimilar, for wet age-related macular degeneration (AMD). Enzeevu (aflibercept-abzv) will be ...
Lenz Submits NDA to US FDA for LNZ100 Presbyopia Drop Candidate
Lenz Therapeutics announced Aug. 12 that it had submitted a new drug application to the US FDA for LNZ100, a once-daily, preservative-free eye drop candidate for presbyopia. Lenz, of San Diego, Cal...
US FDA Approves Generic Prednisolone Acetate Drops from India’s Lupin for Ocular Inflammation
Indian drugmaker Lupin announced Aug. 5 that the US FDA had approved its abbreviated new drug application for prednisolone acetate ophthalmic suspension, 1%, a generic equivalent of AbbVie’s Pred F...
LumiThera Gains CPT Code to Report Retinal PBM Therapy, a Step Toward Reimbursement
LumiThera announced Aug. 7 that a new Category III CPT code had been established, effective Jan. 1, 2025, to report “Photobiomodulation therapy of retina, single session.” The company said the code...
Santen Licenses Cloudbreak Topical Pterygium Candidate for Japan, Korea, and Southeast Asia
Japan’s Santen announced Aug. 6 that it had signed an agreement to license CBT-001, a topical pterygiumtreatment candidate from Cloudbreak Pharma. The deal covers the territories of Japan, South Ko...
US FDA Approves Expanded Access Program for Ocugen’s RP Candidate
Ocugen announced Aug. 5 that the US FDA had approved an expanded access program to allow for the treatment of adults with retinitis pigmentosa (RP) with OCU400—a modifier gene therapy product candi...
Lensar Ends Collaboration with Oertli for Phaco Portion of Ally Cataract System
Lensar has terminated its collaboration agreement with Swiss company Oertli, according to a filing Aug. 5 with the US Securities and Exchange Commission. The two had been developing the Ally Adapti...
Q2-2024 Ophthalmic Revenue Roundup for Hoya, Harrow, RxSight, Sight Sciences, Ocular Therapeutix, and EyePoint
Japan-based Hoya Corporation announced Aug. 1 that its medical care segment (IOLs, endoscopes, artificial bone) had revenue for the quarter ending June 30, 2024—the first quarter of its fiscal year...
USC Alums Gift Eye Care Practice to Roski Eye Institute
Richard Weise, MD, and his wife, Cathy, have gifted their ophthalmic practice, the Glendale Eye Medical Group, of Glendale, California, to the USC Roski Eye Institute, the university announced July...
Physician With Blepharospasm Fights MACs’ Proposed Limits on Botulinum Toxin Injections
Patients with blepharospasm, a rare ophthalmic disease, are facing a proposal by five of the seven Medicare administrative contractors to limit the botulinum toxin injections that control their sym...
Mallinckrodt Announces Availability of Acthar Gel SelfJect Injector in the US
Ireland-based Mallinckrodt announced Aug. 6 that its H.P. Acthar Gel single-dose prefilled SelfJect injector was available in the US. The US FDA approved the supplemental new drug application (sNDA...
NEI Would Fold Into Another NIH Institute Under Lawmaker’s Proposed Restructuring
The status of the National Eye Institute (NEI) as a separate unit within the National Institutes of Health (NIH) would come to an end under a proposal by a US House committee chair to consolidate t...
Formosa Licenses Clobetasol Propionate Drops to Apotex for Canada
Taiwan-based Formosa Pharmaceuticals announced Aug. 5 that it had agreed to license to Apotex exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain...
Eyedaptic Unveils Eye6 with Ivy AI-Assisted Visual Aid
Eyedaptic, of Laguna Hills, California, reported Aug. 5 that it had unveiled its Eye6 with Ivy next-generation wearable vision aid for those with age-related macular degeneration or other retinal d...
HCP Cureblindness Rebrands as Cure Blindness Project
HCP Cureblindness has rebranded as the Cure Blindness Project, the group announced July 29. The move is designed to better reflect the eye charity’s expanded geographical footprint and commitment t...
ViaLase Gains CE Marking for Femtosecond Laser for Glaucoma Treatment
ViaLase announced July 30 that the European Union had granted CE marking for its ViaLase Laser for the treatment of adults with primary open-angle glaucoma. The system uses an OCT-guided femtosecon...
Q2-2024 Ophthalmic Revenue Roundup for Regeneron, Roche, Bausch + Lomb, Novartis, and Four Others
Regeneron, of Tarrytown, New York, reported Aug. 1 that its Q2-2024 US revenue for Eylea was $1.53 billion, a 2 percent increase from $1.5 billion in Q2-2023. Eylea HD accounted for $304 million of...
Roche’s Vabysmo Gains EU Approval for Third Indication—RVO
Swiss drugmaker Roche announced July 30 that the European Commission had approved Vabysmo for a third indication, the treatment of macular edema due to retinal vein occlusion (RVO). Vabysmo (farici...
Novaliq Receives Positive CHMP Opinion for Vevizye in Dry Eye
Germany’s Novaliq announced July 29 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended marketing authorization in the European Union for Vevi...
Eyenovia, SGN Nanopharma Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser
Eyenovia, of New York, announced July 30 that it had entered into a collaboration agreement with SGN Nanopharma to develop SGN’s micellar nanoparticle platform-based cyclosporine formulation for us...
OHSU Researchers Discover Link Between Proteins in Tears, Pain After Eye Surgery
Researchers at Oregon Health & Science University (OHSU) say they have discovered a connection between postsurgical ocular pain and levels of certain proteins found in patients’ tears. Some patient...
US FDA Grants Rare Pediatric Drug Status to Theriva’s Retinoblastoma Candidate
Theriva Biologics, of Rockville, Maryland, announced July 31 that the US FDA had granted rare pediatric drug designation for VCN-01, its treatment candidate for retinoblastoma. The FDA had already ...
Adverum Receives US FDA’s RMAT Designation for Ixo-vec in Wet AMD
Adverum Biotechnologies announced Aug. 1 that Ixo-vec, its intravitreal gene therapy candidate for wet age-related macular degeneration (AMD), had received the US FDA’s regenerative medicine advanc...
Bausch + Lomb Acquires Dry Eye Diagnostic Company Trukera Medical
Bausch + Lomb announced July 23 that it had acquired dry eye diagnostic company Trukera Medical from its private equity owner, AccelMed Partners, and other shareholders. No financial details were d...
Eyenovia, Senju Will Collaborate on Chronic Dry Eye Candidate with Optejet Microdoser
Eyenovia, of New York, announced July 23 that it had entered into a collaboration agreement with Japan’s Senju Pharmaceutical to develop Senju’s corneal epithelial wound healing candidate, SJP-0035...
Samsara Says First SING IMT for AMD Has Been Implanted in China
Samsara Vision, of Far Hills, New Jersey, announced July 22 that the first SING IMT procedure for age-related macular degeneration (AMD) had been completed in China. The SING IMT, which stands for ...
New OTC Eye Lubricants Available from AbbVie, Ocusoft
AbbVie has introduced two new preservative-free lubricant eye drop products—Refresh Tears PF and Refresh Relieva PF Xtra. AbbVie, of North Chicago, Illinois, said the new products feature a soft-sq...
Cancer Company TME Pharma Plans to Spin Off NOX-E36 for Eye Disease
Germany’s TME Pharma, a clinical-stage cancer company, announced July 22 that it planned to spin off its asset NOX-E36 to advance it for eye disease. NOX-E36 is an L-stereoisomer RNA aptamer inhibi...
Advisory Panel Recommends Orphan Drug Status for SIFI’s Polihexanide in Fungal Keratitis
Italy’s SIFI announced July 22 that a European advisory panel had recommended orphan drug designation for its polihexanide eye drop for fungal keratitis. The Committee for Orphan Medicinal Products...
Beacon Appoints Lance Baldo, MD, as Chief Executive Officer
Beacon Therapeutics announced July 24 that it had named Lance Baldo, MD, as chief executive officer, effective Aug. 12, 2024. Most recently, Baldo served as chief medical officer at Freenome, an ea...
EssilorLuxottica Acquires Majority Stake in Diagnostics Maker Heidelberg
Eyewear conglomerate EssilorLuxottica announced July 17 that it had agreed to acquire an 80 percent stake in Heidelberg Engineering, a leader in ophthalmic diagnostic imaging. Financial details wer...
Claes H. Dohlman, MD, PhD, Corneal Research Pioneer and Inventor of the Boston KPro, Dies at 101
Claes H. Dohlman, MD, PhD, considered by many to be the father of modern corneal science, died July 14, Massachusetts Eye and Ear announced in a press release. He was 101. Dohlman, who was born in ...
Medicare Advantage Insurers Make Millions Off Ophthalmic Diagnoses They Add to Patient Records, WSJ Reports
Private insurers involved in the US Medicare Advantage program added hundreds of thousands of questionable diagnoses, including those for diabetic cataracts, to patient records in recent years to b...
J&J Vision Generates Q2-2024 Surgical Revenue of $367 Million
J&J Vision’s Q2-2024 global surgical revenue totaled $367 million, a 0.5 percent decrease (1.2 percent increase in constant currency) from $369 million in Q2-2023, parent Johnson & Johnson, of New ...
Beacon Will Evaluate Abeona’s AAV204 Capsid for Select Ophthalmic Indications
Beacon Therapeutics will evaluate Abeona Therapeutics’ patented AAV204 capsid for potential gene therapies for select ophthalmic indications, the companies announced July 11. AAV204, a novel AAV ca...
NexThera Files IND with US FDA for Trial of Wet AMD Eye Drop Candidate
NexThera, of Busan, South Korea, announced July 16 that it had filed an investigational new drug (IND) application with the US FDA for a Phase I/IIa trial of NT-101, an eye drop candidate for wet a...
Ophthalmic Chain in Colorado Closing All Six Clinics, Citing COVID-19 Financial Fallout
Rocky Mountain Eye Center, based in Pueblo, Colorado, announced on its website that it will close all of its six clinics on July 31, saying the practice was unable to recover from the financial fal...
Okyo Pharma to Initiate Phase II Trial for OK-101 in Neuropathic Corneal Pain
London’s Okyo Pharma announced July 11 that it would advance OK-101 into a Phase II clinical trial of neuropathic corneal pain (NCP). The US FDA cleared the investigational new drug (IND) applicati...
Eyenuk Appoints Bryan Haardt as Chief Executive Officer
Digital health care company Eyenuk, of Los Angeles, California, announced July 18 that it had appointed Bryan Haardt as chief executive officer. Paul Praino, who had been serving as Eyenuk’s interi...
Sydnexis Appoints Perry J. Sternberg as Chief Executive Officer
Sydnexis, of Del Mar, California, announced July 16 that Perry J. Sternberg had been appointed chief executive officer and as a member of the board of directors. He will join the company on Aug. 5,...
UK Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD
Outlook Therapeutics announced July 8 that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) had granted marketing authorization for Lytenava, an ophthalmic formulation of bevaciz...
Ophthalmic Devices to be Included in FDA TAP Program
The US FDA announced July 1 that it was expanding its TAP pilot program in October to include ophthalmic devices, as well as radiological health devices. The voluntary program, officially named the...
US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, RVO
Genentech, a member of the Roche Group, announced July 5 that the US FDA had approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD...
Genentech to Reintroduce Susvimo for Wet AMD, Ending Voluntary Recall
Genentech, a member of the Roche Group, announced July 8 that it was reintroducing Susvimo, a refillable ranibizumab intravitreal implant for wet age-related macular degeneration (AMD) in the US, e...
Ophthalmology Chain Clínica Baviera Enters UK Market with Acquisition of Optimax
European ophthalmology chain Clínica Baviera has extended its reach into the UK with the purchase of Optimax. Optimax (Eye Hospitals Group and subsidiaries) operates 19 clinics under the Optimax an...
Altos Biologics Files for European Approval of Aflibercept (Eylea) Biosimilar
Altos Biologics has submitted a marketing authorization application to the European Medicines Agency (EMA) for ALT-L9, an aflibercept (Eylea) biosimilar, according to a joint announcement by Altos ...
China’s DP Technology Will Advance Oral Lp-PLA2 Inhibitor for DR and DME
China’s DP Technology announced July 8 that it would advance DPT0415, a novel small molecule targeting lipoprotein‐associated phospholipase A2 (Lp-PLA2), as a potential oral treatment candidate for...
Alkeus Appoints Michel Dahan as President and CEO
Alkeus Pharmaceuticals announced July 2 that Michel Dahan had joined the company as president and chief executive officer. He had served as a member of the board since January 2023. Alkeus, of Camb...
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