Latest Industry News & Trends

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...

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...

Ophthalmologists Report 5.5 Percent Increase in Q3-2024 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 5.5 percent in Q3-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...

Select US FDA Approvals and Clearances in November 2024

The US FDA granted one clearance through the ophthalmic device division using the 510(k) pathway in November 2024, according to the agency’s database. Novoxel, a newcomer to ophthalmology but not m...

PDUFA Dates for Ophthalmic Drug Candidates

The US FDA has scheduled the following Prescription Drug User Fee Act (PDUFA) target action dates for ophthalmic drug, drug/device, and biologic candidates.

NIH Joins Push to Fund Breakthroughs in Oculomics Diagnostic Tech

The National Institutes of Health (NIH) is joining the push to fund the development of technologies and biomarkers to diagnose systemic disease through the eye, a field known as oculomics. The NIH ...

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...

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.

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...

Clinical Trial Updates for Ophthalmic Candidates, December 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Lineage Leads Latest Ophthalmic Fundraising with $66 Million Offering

Lineage Cell Therapeutics led recent ophthalmic fundraising efforts with a registered direct offering worth up to $66 million to advance its RPE cell therapy candidate. Financing announced in the p...

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...

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...

Emerging Companies Pursuing Ophthalmic Indications, December 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

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...

December 2024 Ophthalmic News Briefs

Dutch company Ophtec announced Nov. 18 that it had gained CE marking for its Artiplus phakic IOL. The company said the lens offered a solution for relatively young presbyopes, typically in their ea...

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...

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...

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...

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...

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...

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...

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...

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...

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-...

Gene Therapies Make Progress Toward Goal of Restoring Sight

Gene therapies again generated buzz at the 2024 AAO meeting—as they have at recent meetings—but perhaps most exciting were reports of a treatment that could partially restore severe vision loss fro...

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...

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...

Ophthalmology Continues to Draw Investors, Eyecelerator Meeting Shows; Retina Stands Out

Ophthalmology remains an appealing investment, driven largely by procedural growth. While hundreds of companies are working toward technology enhancements and innovative therapies, ophthalmology pr...

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...

US FDA Asks for Added Data on Neurotech MacTel Candidate, Delays 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 Grants De Novo Classification to LumiThera’s System for Dry AMD

LumiThera announced Nov. 4 that the US FDA had granted market authorization through the de novo pathway for the Valeda photobio-modulation system for treatment of patients with dry age-related macu...

EyePoint Leads Latest Ophthalmic Fundraising with $161 Million Public Offering

EyePoint Pharmaceuticals led recent ophthalmic fundraising efforts with a $161 million upsized underwritten public offering. Proceeds in part will fund clinical development of Duravyu. Financing an...

The New Opus Genetics Charts a Course to Gene Therapy Approval

Ben Yerxa, PhD, and George Magrath, MD, say they have a way out of the jungle in which ocular gene therapy development has been trapped since the US FDA approved Luxturna in 2017. “You have to be r...

Are Drugs for GA in the ‘Trough of Disillusionment’?

The celebrations and excitement that accompanied the launch in 2023 of the first two drugs approved in the US for the treatment geographic atrophy (GA) gave way to a hangover and regrets at the 202...

Weighing the Ophthalmic Impact of Boom in GLP-1 Receptor Agonist Treatment

Recent studies indicate that up to 6 percent of the US population is currently taking a GLP-1 receptor agonist, a class of drugs prescribed to help manage blood glucose levels for diabetes and weig...

Alcon Looks to Refine Retinal Surgery with Unifeye, Unipexy

Alcon launched at the 2024 AAO meeting two new retinal surgical devices—Unifeye for air-gas exchange and Unipexy for retinopexy. Each is a one-person, hand-held, single-use gas delivery device. The...

Clinical Trial Updates for Ophthalmic Candidates, November 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Pine 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...

Emerging Companies Pursuing Ophthalmic Indications, November 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

November 2024 Ophthalmic News Briefs

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...

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...

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...

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...

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...

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...

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...

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 ...

EU Regulators Rain on Apellis’ Party at 2024 Euretina Congress

The big news at the 24th Euretina congress was something that didn’t happen at the congress. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) embarrassed Apelli...

Orasis Leads Latest Ophthalmic Deals with $78 Million Financing

Orasis Pharmaceuticals led recent ophthalmic fundraising efforts with $78 million in Series D and structured capital to support the launch of Qlosi drops for presbyopia. Financing announced in the ...

Emerging Companies Pursuing Ophthalmic Indications, October 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Retina Specialists Grapple with Functional Endpoints in Clinical Trials

European regulators’ repeated rejection of Syfovre made one thing very clear to retina specialists at Euretina: “Treatment should have an impact on everyday function,” said Thomas Ach, MD (Germany)...

Retina Surgeons at European Meetings Ask, ‘What’s New?’

Experienced retina surgeons among the approximately 8.1 thousand attendees at Euretina in Barcelona, Spain, were underwhelmed by the surgical devices that industry had on display. “There is nothing...

First GA Therapies at Crossroads as EU Regulators Unconvinced Benefits Outweigh Risks

The negative opinion of Syfovre by a key EU regulatory committee has thrown the global marketing plans for complement inhibitors for GA into disarray. Two companies—Apellis Pharmaceuticals and Aste...

Clinical Trial Updates for Ophthalmic Candidates, October 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Harrow to Add Nearly 150 Jobs as it Expands in Nashville, Relaunches Triesence

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 ...

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 ...

October 2024 Ophthalmic News Briefs

Oculus has announced the addition of frequency doubling perimetry (FDP) to its Easyfield VR visual field diagnostic headset. The German ophthalmic diagnostic company, with US headquarters in Arling...

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...

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...

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. ...

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 ...

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...

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...

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 ...

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...

Ophthalmic Company Revenue Up 2.6 Percent; Several Public Firms Report Record-High Quarters

Ophthalmic manufacturer revenue in Q2-2024 totaled $11.7 billion. Revenue increased 2.6 percent from the same quarter in 2023 and increased 5.9 percent from Q1-2024. The total includes Market Scope...

Ophthalmologists Report 0.5 Percent Increase in Q2-2024 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 0.5 percent in Q2-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...

New Drugs for Exudative Retinal Disease Lift Companies Over Patent Cliffs

Roche faced an ophthalmic patent cliff in the US before Regeneron. First, Roche introduced an extended duration alternative to its flagship inhibitor of vascular endothelial growth factor (anti-VEG...

ONL Leads Latest Ophthalmic Fundraising with $65M Series D Round

ONL Therapeutics led recent ophthalmic fundraising efforts with a $65 million Series D round to continue advancing its small-molecule Fas inhibitor for retinal disease. Financing announced in the p...

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...

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...

Emerging Companies Pursuing Ophthalmic Indications, September 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

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...

Clinical Trial Updates for Ophthalmic Candidates, September 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

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...

September 2024 Ophthalmic News Briefs

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 ...

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 (...

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 ...

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...

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...

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...

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...

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 ...

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...

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...

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, ...

Wnt Agonists and Optogenetics Create Excitement at 2024 ASRS Meeting in Sweden

Impressive new science and challenging business conditions topped the discussions at the American Society of Retina Specialists’ 2024 annual meeting. The conference took place July 17-20 in Stockho...

Select US FDA Approvals and Clearances in July 2024

The US FDA granted two clearances through the ophthalmic device division using the 510(k) pathway in July 2024, according to the agency’s database. Topcon gained clearance for its Maestro2 OCT in c...

MeiraGTx Leads Latest Ophthalmic Fundraising with $50 Million Offering

MeiraGTx led recent ophthalmic fundraising efforts with a $50 million offering of ordinary shares as it moves forward with its extensive pipeline of gene therapy candidates. Financing announced in ...

Clinical Trial Updates for Ophthalmic Candidates, August 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Emerging Companies Pursuing Ophthalmic Indications, August 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

August 2024 Ophthalmic News Briefs

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 for t...

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 ...

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...

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...

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...

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...

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...

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...

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 ...

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...

Beacon Leads Latest Ophthalmic Fundraising with $170 Million in Series B

Beacon Therapeutics led recent ophthalmic fundraising efforts with $170 million in Series B funding to advance its candidates for retinal disease. Financing announced in the past four weeks totaled...

Emerging Companies Pursuing Ophthalmic Indications, July 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Clinical Trial Updates for Ophthalmic Candidates, July 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

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...

US FDA Approves Vabysmo Prefilled Syringe for Wet AMD, DME, and RVO Indications

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...

Weekly Surgeon Poll, July 2024

July 2024 Ophthalmic News Briefs

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...

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...

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...

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...

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...

US FDA Approves Aflibercept (Eylea) Biosimilar from Formycon, Klinge

German companies Formycon and Klinge Biopharma announced June 28 that the US FDA had approved their aflibercept (Eylea) biosimilar for wet age-related macular degeneration (AMD), diabetic macular e...

Roche’s Vabysmo Gains Positive CHMP Opinion in EU for Third Indication—RVO

Swiss drugmaker Roche announced June 28 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended the extension of Vabysmo’s labeling to include tre...

RevOpsis Enlists India’s Kemwell Biopharma to Manufacture Wet AMD Candidate

RevOpsis Therapeutics, of San Carlos, California, announced June 17 that it had entered into a strategic manufacturing partnership with India’s Kemwell Biopharma. The deal aims to accelerate develo...

Alcon Gains US FDA 510(k) Clearance for Unity VCS and CS Systems

Alcon reported June 24 that itsUnity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS) had received US FDA 510(k) clearance. The company said it would be seeking real-world feedbac...

Harrow Looks to Relaunch Triesence in 2024, as Production Testing Continues

Nashville, Tennessee-based Harrow reported June 20 that it was moving closer to relaunching Triesence in 2024 after successfully achieving a production testing milestone. Triesence (triamcinolone a...

US FDA Accepts BLA for Neurotech’s MacTel Candidate, Grants Priority Review

Neurotech Pharmaceuticals announced June 20 that the US FDA had accepted its biologic license application (BLA) and granted priority review for NT-501, an encapsulated cell therapy implant candidat...

US FDA Gives Green Light to Trial of 4DMT’s Gene Therapy Candidate for GA

4D Molecular Therapeutics announced June 24 that the US FDA had cleared its investigational new drug application for a Phase I clinical trial of 4D-175, an intravitreal gene therapy candidate targe...

Ophthalmologists Report 6 Percent Decline in Q1-2024 Procedure Volume

US ophthalmologists reported that ophthalmic procedures decreased 6.0 percent in Q1-2024 compared with the same quarter in 2023, according to Market Scope’s latest survey. Year-over-year performanc...

EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD

Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...

COVID-19 Virus Crosses Blood-Retinal Barrier, Researchers at University of Missouri Find

The virus that causes COVID-19 can breach the blood-retinal barrier, with potential long-term consequences for eye health, researchers at the University of Missouri School of Medicine have discover...

Low-Dose Aspirin Shows No Effect in Incidence, Progression of AMD

An analysis of more than 3,100 older adults, published May 23 in JAMA Ophthalmology, showed that low-dose aspirin taken for three years did not affect the incidence or progression of age-related ma...

Apellis Reports Syfovre Preserved Visual Function at 36 Months in Extension Study

Apellis Pharmaceuticals reported June 10 that Syfovre (pegcetacoplan injection), its treatment for geographic atrophy (GA), preserved visual function at 36 months in the GALE long-term extension st...

Clinical Trial Updates for Ophthalmic Candidates, June 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

Opthea Leads Latest Fundraising with $113.2M Placement, Entitlement Offer

Opthea led recent ophthalmic fundraising efforts with a $113.2 million placement and entitlement offer, as it continues to advance its wet AMD candidate. Financing announced in the past four weeks ...

Merck to Acquire Retinal Drug Developer EyeBio in Deal Worth up to $3 Billion

Merck, of Rahway, New Jersey, announced May 29 that it was acquiring Eyebiotech Limited (EyeBio) for an upfront payment of $1.3 billion and up to $1.7 billion in future milestone payments. The deal...

June 2024 Ophthalmic News Briefs

Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas OCT system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlined workflow and advanced analyt...

Opus Genetics, Abu Dhabi to Collaborate on Retinal Gene Therapies in UAE

Opus Genetics and Abu Dhabi’s Department of Health announced June 5 that they had agreed to collaborate on the development of gene therapies for patients with rare inherited retinal diseases in the...

Low-Dose Aspirin Shows No Effect in Incidence, Progression of AMD

An analysis of more than 3,100 older adults, published May 23 in JAMA Ophthalmology, showed that low-dose aspirin administered for three years did not affect the incidence or progression of age-rel...

Apellis Reports Syfovre Preserved Visual Function at 36 Months in Extension Study

Apellis Pharmaceuticals reported June 10 that Syfovre (pegcetacoplan injection), its treatment for geographic atrophy (GA), preserved visual function at 36 months in the GALE long-term extension st...

Adverum Appoints Rabia Gurses Ozden, MD, as Chief Medical Officer

Adverum Biotechnologies announced June 11 that it had appointed Rabia Gurses Ozden, MD, as chief medical officer. Ozden is stepping down from the seat she held on Adverum’s board. Retina specialist...

Nidek Launches RS-1 Glauvas OCT System

Japan’s Nidek announced June 3 that it had launched the RS-1 Glauvas optical coherence tomography (OCT) system. The device is CE marked as a Class IIa device. Nidek said the RS-1 Glauvas’ streamlin...

Belite Bio Receives Sakigake (Pioneer Drug) Nod in Japan for Tinlarebant in Stargardt

Belite Bio announced June 12 that Japanese regulators had granted the Sakigake, or pioneer therapy, designation to its lead candidate, tinlarebant, an oral tablet targeting Stargardt disease. Belit...

LambdaVision Reports First Closing of Seed Round to Advance Artificial Retina

LambdaVision, of Farmington, Connecticut, reported May 29 that it had secured the first closing of a seed round, let by Aurelia Foundry Fund, a fund spun out of Massachusetts Institute of Technolog...

Regenxbio Appoints Simpson as President, CEO; Co-founder Mills Transitions to Chairman

Regenxbio announced June 12 that its chief operating officer, Curran Simpson, had been appointed president and chief executive officer. He will also join the board of directors. Co-founder Kenneth ...

US FDA Gives Green Light to Trial of Avirmax’ Gene Therapy Candidate for Wet AMD with PCV

Avirmax Biopharma announced May 30 that the US FDA had cleared its investigational new drug application for a Phase I/IIa clinical trial of its intravitreal gene therapy candidate targeting wet age...

Merck to Acquire Retinal Drug Developer EyeBio in Deal Worth up to $3 Billion

Merck, of Rahway, New Jersey, announced May 29 that it was acquiring Eyebiotech Limited (EyeBio) for an upfront payment of $1.3 billion and up to $1.7 billion in future milestone payments. The deal...

EU Regulators Approve Outlook’s Lytenava (Bevacizumab) for Wet AMD

Outlook Therapeutics announced May 28 that the European Commission had granted marketing authorization for Lytenava, an ophthalmic formulation of bevacizumab for the treatment of wet age-related ma...

HanAll Licenses Turn Bio mRNA Technology for Eye and Ear Diseases

South Korea-based HanAll Biopharma announced May 28 that it had licensed Turn Biotechnologies’ epigenetic reprogramming technology for eye and ear diseases. The company said the deal could be worth...

US FDA Approves First Interchangeable Biosimilars to Eylea

The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...

Q1-2024 Ophthalmic Revenue Roundup for AbbVie, Iridex, and Biogen

AbbVie, of North Chicago, Illinois, reported April 26 that its Q1-2024 eye care net revenue totaled $538 million, an 11.7 percent decline (-10.4 percent cc) from $608 million in Q1-2023. Restasis r...

Champalimaud Vision Award Recognizes Eye Hospital Serving Gaza and West Bank

A sparsely attended Champalimaud Vision Award Lecture at the 2024 ARVO meeting highlighted the work of St. John of Jerusalem Eye Hospital in Gaza, Jerusalem, and the West Bank. Leonor Beleza, presi...

US FDA Gives Green Light to Phase Ib Trial of Drug Farm’s Oral ALPK1 Inhibitor in ROSAH Patients

Drug Farm, of Shanghai, China, announced May 17 that the US FDA had cleared its investigational new drug (IND) application for a Phase Ib trial of its DF-003, an oral alpha kinase 1 (ALPK1) inhibit...

Guidelines for Suprachoroidal Drug Delivery Published in Journal Retina

Retina, The Journal of Retinal and Vitreous Diseases, has published new guidelines that represent best practices for injection of therapies into the suprachoroidal space (SCS). The article, publish...

2024 ARVO Meeting Sets Attendance Record, Showcases Novel Treatment Approaches

The 2024 meeting of the Association for Research in Vision and Ophthalmology set a record as the largest ARVO meeting ever. The 11,631 registered attendees passed the old record of 10,224 set in Va...

Researcher, Patient Guide Next Stage for a Wireless Intracortical Visual Prosthesis

Philip Troyk, PhD, and Brian Bussard are unsung heroes of the multi-decade effort to give blind people artificial vision by means of cortical implants. They want more people to join them. Troyk, a ...

US FDA Grants De Novo Authorization to Notal Vision’s Scanly AI-Powered Home OCT

Notal Vision announced May 16 that the US FDA had granted de novo marketing authorization for its patient-operated Scanly home optical coherence tomography (OCT) device. The Scanly uses artificial ...

RxSight Leads Latest Ophthalmic Fundraising with $115 Million Public Offering

RxSight led recent ophthalmic fundraising efforts with a $115 million public offering to continue commercialization of its Light Adjustable Lens portfolio. Financing announced in the past four week...

US FDA Approves First Interchangeable Biosimilars to Eylea

The FDA announced May 20 that it had approved the US’ first interchangeable biosimilars to Eylea (aflibercept)— Yesafili, from India’s Biocon Biologics, and Opuviz, which was jointly developed by B...

California-Based Science Corporation Acquires Pixium Vision’s Prima Implant

Science Corporation, of Alameda, California, reported April 25 that it had acquired the IP and related assets for the Prima retinal implant, developed by Pixium Vision SA, of France. Terms of the d...

Emerging Companies Pursuing Ophthalmic Indications, May 2024

Market Scope is tracking companies that have announced new candidates to diagnose and treat eye disease.

Euretina President Ramin Tadayoni, MD, PhD, Dies at 54

The European Society of Retina Specialists, or Euretina, reported April 20 that its president, retina specialist Ramin Tadayoni, MD, PhD, had died. He was 54. Tadayoni was attending the Brazilian R...

Xbrane, Stada Partner with Valorum to Commercialize Ranibizumab Biosimilar in US

Partners Xbrane Biopharma, of Sweden, and Germany’s Stada announced May 10 that they had entered into an exclusive licensing agreement with biosimilar company Valorum Biologics to market their rani...

Ophthalmic Companies Use ARVO Meeting to Boost Research

Many companies participate in ARVO’s annual meeting to catch the attention of external researchers and propel their research program or clinical trials forward. Two such companies in 2024 were John...

Artificial Intelligence Takes Leading Role at 2024 ARVO Meeting

Artificial intelligence was a prominent topic at the 2024 ARVO meeting. Discussions ranged from using AI in published ophthalmic research to employing it in early detection and monitoring of eye di...

2024 ARVO Awards Highlight New Focus on Inflammation

The Weisenfeld and Cogan awards and lectures at the 2024 ARVO meeting put a spotlight on inflammation. Martine Jager, MD, PhD (Netherlands), received the Weisenfeld Award in recognition of her pion...

Clinical Trial Updates for Ophthalmic Candidates, May 2024

Market Scope is tracking companies that have announced clinical trial updates or milestone achievements.

May 2024 Ophthalmic News Briefs

Taiwan-based Formosa Pharmaceuticals announced May 9 that it had entered into an exclusive licensing agreement with Tabuk Pharmaceuticals to market clobetasol propionate 0.05% eye drops for post-su...