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Cornea Transplant Market Continues to Face Procurement Challenges, as New Approaches on Rise
Cornea Transplant Market Continues to Face Procurement Challenges, as New Approaches on Rise

An estimated 1 million corneas are needed each year to meet the demand of those who could benefit from a transplant. Several factors contribute to the global shortage of corneal tissue. In many cou...

Lineage Leads Latest Ophthalmic Fundraising with $66 Million Offering
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...

NYU Langone Health Hails Recovery of Man Over a Year after Landmark Whole Eye Transplant
NYU Langone Health 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...

ARPA-H Pledges $125 Million to Advance Whole Eye Transplantation
ARPA-H Pledges $125 Million to Advance Whole Eye Transplantation

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...

CMS Cuts Ophthalmologists’ Procedure Fees, While Raising ASC, HOPD Facility Fees
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...

MACs Finalize Coverage for Standalone and Combo MIGS Procedures
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...

Amgen Launches Eylea Biosimilar Pavblu After Court Win Over Regeneron
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
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
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’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...

Weekly Surgeon Poll, December 2024
Weekly Surgeon Poll, December 2024

December 2024 Ophthalmic News Briefs
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...

Bausch + Lomb Acquires Elios Vision, Developer of Excimer Laser Trabeculostomy
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 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
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
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
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
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
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
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
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’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
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 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
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
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
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 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
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
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
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 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
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
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 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 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
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
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
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 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 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
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 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...

Q3-2024 Ophthalmic Revenue Roundup for Alcon, Hoya, RxSight, Sight Sciences, and Iridex
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 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
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
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
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...

Zeiss Bolsters Launch of Micor 700 at AAO Meeting With US Surgeons Discussing Adoption
Zeiss Bolsters Launch of Micor 700 at AAO Meeting With US Surgeons Discussing Adoption

Carl Zeiss Meditec featured its Micor 700 at the 2024 meeting of the American Academy of Ophthalmology in Chicago, Illinois, with presentations that included booth talks by select US surgeons who h...

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

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