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Recently Added News

11/8/2024
BreakingDeviceRegulationRetina
US FDA Grants De Novo Classification to LumiThera’s Photobiomodulation System for Dry AMD
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...

11/8/2024
BreakingCataractCornealDry EyeGlaucomaLaserPharmaPresbyopiaRefractiveRetinaRevenueSurgical
Q3-2024 Ophthalmic Revenue Roundup for AbbVie, Apellis, Glaukos, STAAR, and Lensar
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...

11/8/2024
BreakingDealsDry Eye
NovaBay Accepts Higher Offer from PRN to Purchase Assets
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...

11/8/2024
BreakingRegulationRetina
US FDA Asks for Added Data on Neurotech MacTel Candidate, Pushes Back PDUFA Date
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...

11/8/2024
BreakingChinaGene TherapyRegulationRetina
US FDA Gives Green Light to Phase I Trial of HuidaGene’s CRISPR RNA-Editing Candidate for Wet AMD
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...

11/8/2024
BreakingCataractDealsEuropePharma
DÁVI Licenses Clobetasol Propionate Post-op Drops from Formosa for Portugal
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...

11/8/2024
BreakingDry EyeIndustry
Tarsus Appoints Elizabeth Yeu, MD, as Chief Medical Officer
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 ...

11/1/2024
BreakingEuropePharmaRegulationRetina
Astellas Withdraws EU Marketing Application for Avacincaptad Pegol in GA
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) ...

11/1/2024
BreakingIOLPharmaRetinaRevenue
Q3-2024 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, and Novartis
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...

11/1/2024
BreakingPharmaRetinaStudy
Vabysmo Improved Vision in Underrepresented Populations with DME in Elevatum Study
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...

11/1/2024
BreakingDeviceRegulation
Michelle Tarver, MD, PhD, an Ophthalmologist, Named Director of FDA’s CDRH
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...

11/1/2024
BreakingDealsDry Eye
NovaBay Receives Higher Asset Purchase Bid from RVL-Affiliated Company
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...

Past News Stories

11/1/2024
BreakingClinical TrialPharmaRetina
Alkeus’ Oral Gildeuretinol for GA Shows Positive Topline Results in Phase III
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...

11/1/2024
BreakingFundingPharmaRetina
RevOpsis Awarded $1.8 Million NEI Grant to Advance Retinal Candidate RO-104
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...

11/1/2024
BreakingDealsPharmaRetina
Korean Companies GC Biopharma, Novelty Nobility to Collaborate on GA Drug Discovery
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...

10/25/2024
BreakingPharmaRetina
Pine Pharmaceuticals Stops Compounding IVT Avastin, Creating Concerns Over Shortage
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...

10/25/2024
BreakingIOLPharmaRetinaRevenueSurgical
Q3-2024 Ophthalmic Revenue Roundup for Roche and J&J Vision
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...

10/25/2024
BreakingPresbyopiaRegulation
US FDA Accepts NDA For Lenz’ Presbyopia Drop Candidate
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...

10/25/2024
BreakingDealsGene TherapyPresbyopiaRefractiveRetina
Ocuphire Pharma Acquires Opus Genetics, Will Operate Under Opus Name
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...

10/25/2024
BreakingDiagnosticDry EyeFundingStudy
ARPA-H Seeks Proposals for Tear Duct-Based Diagnostic System, Plus Custom Dosing Platform
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...

10/25/2024
BreakingClinical TrialLow VisionProsthesisRetina
Preliminary Results Show Prima Implant Allows for Functional Vision in Advanced GA Patients
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...

10/25/2024
BreakingCornealDealsDry EyeFundingStudy
Grifols, BARDA Partner on Ocular Immunoglobulin Drops for Sulfur Mustard Exposure
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...

10/25/2024
BreakingInstrumentsSingle-UseSurgical
Corza Launches Onatec Ophthalmic Microsurgical Suture Portfolio
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...

10/18/2024
BreakingCataractIOLRegulationSurgical
Bausch + Lomb Gains US FDA Approval of enVista Envy Trifocal IOL
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. ...

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