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PDUFA Dates for Ophthalmic Drug Candidates, February 2026
PDUFA Dates for Ophthalmic Drug Candidates, February 2026

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

US FDA Approves Tenpoint’s Yuvezzi Drops for Presbyopia
US FDA Approves Tenpoint’s Yuvezzi Drops for Presbyopia

Tenpoint Therapeutics announced Jan. 28 that the US FDA had approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) for presbyopia. The company said it expects to launc...

BioAge Leads Latest Ophthalmic Fundraising with $115 Million Offering
BioAge Leads Latest Ophthalmic Fundraising with $115 Million Offering

BioAge led recent ophthalmic fundraising efforts with a $115 million upsized public offering to advance an oral treatment candidate for DME. Financing announced in the past four weeks totaled $308....

New US Law Institutes Major Pharmacy Benefit Manager Reforms in 2029
New US Law Institutes Major Pharmacy Benefit Manager Reforms in 2029

The $1.2 trillion US spending package signed into law on Feb. 3 includes major reforms to pharmacy benefit manager (PBM) practices. These provisions go into effect for health plan years that come a...

2026-2027 Ophthalmic Meetings Calendar
2026-2027 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.

Market Scope’s G360 Attendee Survey Looks at Patient Fears over Laser Therapy
Market Scope’s G360 Attendee Survey Looks at Patient Fears over Laser Therapy

Market Scope conducted an online survey of Glaucoma 360 meeting attendees in January and February as part of our 11-year partnership with the Glaucoma Research Foundation for its annual meeting. Th...

Clinical Trial Updates for Ophthalmic Candidates, February 2026
Clinical Trial Updates for Ophthalmic Candidates, February 2026

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

Ocular Therapeutix Reports Positive Results for Axpaxli vs. Eylea in Phase III Wet AMD Trial
Ocular Therapeutix Reports Positive Results for Axpaxli vs. Eylea in Phase III Wet AMD Trial

Ocular Therapeutix reported on Feb. 17 positive topline results in the SOL-1 Phase III superiority trial of Axpaxli vs. Eylea (aflibercept) in wet age-related macular degeneration (AMD). Axpaxli, a...

Samsung Bioepis’ Deals with Regeneron Clear Way for Eylea Biosimilar
Samsung Bioepis’ Deals with Regeneron Clear Way for Eylea Biosimilar

Samsung Bioepis reported Feb. 12 that it had reached a settlement and license agreement with Regeneron that will allow its biosimilar to Eylea, branded Opuviz, to be launched in the US in January 2...

American College of Eye Technicians Offers Fast-Track Virtual Training Program
American College of Eye Technicians Offers Fast-Track Virtual Training Program

The American College of Eye Technicians (ACET) recently opened enrollment for its fast-track virtual training program, an eight-week session that combines interactive activities and coursework to p...

STAAR Names Warren Foust and Deborah Andrews as Interim Co-CEOs Amid Search for Permanent Leader
STAAR Names Warren Foust and Deborah Andrews as Interim Co-CEOs Amid Search for Permanent Leader

STAAR Surgical, of Lake Forest, California, reported Feb. 2 that it had appointed Warren Foust and Deborah Andrews as interim co-CEOs, while the company conducts a global search for a permanent CEO...

EU-India Free Trade Agreement to Phase in Lower Pharma and Device Tariffs
EU-India Free Trade Agreement to Phase in Lower Pharma and Device Tariffs

A free trade agreement reached Jan. 27 by the European Union and India will reduce or eliminate tariffs on about 90 percent of goods, including pharmaceuticals and medical devices, between the two ...

Emerging Companies Pursuing Ophthalmic Indications, February 2026
Emerging Companies Pursuing Ophthalmic Indications, February 2026

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

Weekly Poll of MDs and ODs, February 2026
Weekly Poll of MDs and ODs, February 2026

AOA Sounds Alert on Eyebot Vision Kiosks, Calls for Greater Oversight
AOA Sounds Alert on Eyebot Vision Kiosks, Calls for Greater Oversight

The American Optometric Association (AOA) is sounding an alert on Eyebot kiosks, where consumers can get 90-second vision tests and doctor-reviewed eyeglass prescriptions. Through a partnership wit...

February 2026 Ophthalmic News Briefs
February 2026 Ophthalmic News Briefs

Belgian investment company Groupe Bruxelles Lambert (GBL) reported Feb. 9 that it would invest 500 million euros (US $594 million, calculated on Feb. 11, 2026) in UK-based ophthalmic company Rayner...

US FDA Will Drop Two-Study Requirement for New Drug Approvals
US FDA Will Drop Two-Study Requirement for New Drug Approvals

The US FDA plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, according to a journal article published Feb. 18. Going forward, the agency’s “defaul...

2025 Ophthalmic Revenue Roundup for Bausch + Lomb and Glaukos
2025 Ophthalmic Revenue Roundup for Bausch + Lomb and Glaukos

Bausch + Lomb reported Feb. 18 that its 2025 revenue totaled $5.1 billion, a 6 percent increase over $4.8 billion in 2024. The company’s Q4-2025 revenue was $1.4 billion, a 10 percent increase over...

US FDA Expands Indication for STAAR’s Evo ICL to Patients Up to Age 60
US FDA Expands Indication for STAAR’s Evo ICL to Patients Up to Age 60

STAAR Surgical announced Feb. 17 that the US FDA had approved an expanded age indication for Evo and Evo+ implantable Collamer lenses (ICLs), extending their use from patients 21 to 45 years old to...

Ocular Therapeutix Reports Positive Results for Axpaxli vs. Eylea in Phase III Wet AMD Trial
Ocular Therapeutix Reports Positive Results for Axpaxli vs. Eylea in Phase III Wet AMD Trial

Ocular Therapeutix reported on Feb. 17 positive topline results in the SOL-1 Phase III superiority trial of Axpaxli vs. Eylea (aflibercept) in wet age-related macular degeneration (AMD). Axpaxli, a...

AOA Sounds Alert on Eyebot Vision Kiosks, Calls for Greater Oversight
AOA Sounds Alert on Eyebot Vision Kiosks, Calls for Greater Oversight

The American Optometric Association (AOA) is sounding an alert on Eyebot kiosks, where consumers can get 90-second vision tests and doctor-reviewed eyeglass prescriptions. Through a partnership wit...

Eye PCR Gains CE Marking for FixOflex Endocapsular Device
Eye PCR Gains CE Marking for FixOflex Endocapsular Device

Eye PCR announced Feb. 13 that its FixOflex endocapsular device had gained CE marking under the European Union Medical Device Regulation, clearing the way for a “controlled market introduction.” Th...

Private Equity Firm Sells Maker of RetEval ERG Device to Ametek
Private Equity Firm Sells Maker of RetEval ERG Device to Ametek

The private equity firm DW Healthcare Partners announced Feb. 3 that it had sold LKC Technologies, maker of the RetEval electroretinogram device, to the global electronic instrument manufacturer Am...

Okyo Pharma Appoints Flavio Mantelli, MD, PhD, as Chief Medical Officer
Okyo Pharma Appoints Flavio Mantelli, MD, PhD, as Chief Medical Officer

London’s Okyo Pharma announced Feb. 10 that it had appointed Flavio Mantelli, MD, PhD, as chief medical officer. Mantelli most recently served as chief medical officer of Dompé, where he led the cl...

Belgian Company Invests 500 Million Euros for 45 Percent Stake in Rayner
Belgian Company Invests 500 Million Euros for 45 Percent Stake in Rayner

Belgian investment company Groupe Bruxelles Lambert (GBL) reported Feb. 9 that it would invest 500 million euros (US $594 million, calculated on Feb. 11, 2026) in UK-based ophthalmic company Rayner...

2025 and Quarterly Ophthalmic Revenue Roundup for Amgen, Santen, Hoya, Lumibird, and Ocular Therapeutix
2025 and Quarterly Ophthalmic Revenue Roundup for Amgen, Santen, Hoya, Lumibird, and Ocular Therapeutix

Amgen, of Thousand Oaks, California, reported Feb. 3 that its 2025 revenue for Tepezza was $1.90 billion, a 3 percent increase over $1.85 billion in 2024, primarily driven by higher net selling pri...

New US Law Institutes Major Pharmacy Benefit Manager Reforms in 2029
New US Law Institutes Major Pharmacy Benefit Manager Reforms in 2029

The $1.2 trillion US spending package signed into law on Feb. 3 includes major reforms to pharmacy benefit manager (PBM) practices. These provisions go into effect for health plan years that come a...

Samsung Bioepis’ Deals with Regeneron Clear Way for Eylea Biosimilar in US, Other Markets
Samsung Bioepis’ Deals with Regeneron Clear Way for Eylea Biosimilar in US, Other Markets

Samsung Bioepis reported Feb. 12 that it had reached a settlement and license agreement with Regeneron that will allow its biosimilar to Eylea, branded Opuviz, to be launched in the US in January 2...

Nordic Pharma Launches Lacrifill Canalicular Gel for Dry Eye in Europe
Nordic Pharma Launches Lacrifill Canalicular Gel for Dry Eye in Europe

Dutch drugmaker Nordic Pharma announced Feb. 5 the European launch of Lacrifill canalicular gel for dry eye. The treatment gained CE marking in April 2025. Lacrifill is a cross-linked hyaluronic ac...

American College of Eye Technicians Offers Fast-Track Virtual Training Program
American College of Eye Technicians Offers Fast-Track Virtual Training Program

The American College of Eye Technicians (ACET) recently opened enrollment for its fast-track virtual training program, an eight-week session that combines interactive activities and coursework to p...

MeiraGTx Licenses ZipBio’s Protein Therapeutic Technology for GA
MeiraGTx Licenses ZipBio’s Protein Therapeutic Technology for GA

MeiraGTx has obtained exclusive rights to protein therapeutic technology for geographic atrophy (GA) from ZipBio, the companies announced Feb. 3. The agreement includes an upfront payment, as well ...

Arctic Vision to Acquire MDCO Technology’s Ophthalmic Device Business
Arctic Vision to Acquire MDCO Technology’s Ophthalmic Device Business

China’s Arctic Vision announced Feb. 2 that it would acquire the ophthalmic device business of MDCO Technology. Arctic Vision said MDCO markets a premium intraocular lens (IOL), a phakic lens, and ...

Alvotech’s Deal with Regeneron, Bayer Clears Way for Eylea Biosimilar in Multiple Markets
Alvotech’s Deal with Regeneron, Bayer Clears Way for Eylea Biosimilar in Multiple Markets

Alvotech, of Reykjavik, Iceland, reported Jan. 29 that it had reached a settlement and license agreement with Regeneron and Bayer that resolves all remaining patent disputes worldwide for its biosi...

Quarterly and 2025 Ophthalmic Revenue Roundup for Roche, Regeneron, AbbVie, Novartis, and Astellas
Quarterly and 2025 Ophthalmic Revenue Roundup for Roche, Regeneron, AbbVie, Novartis, and Astellas

Swiss company Roche reported Jan. 29 that global sales of Vabysmo for 2025 were CHF 4.1 billion ($5.2 billion, converted Dec. 25, 2025), a 6 percent increase on a reported basis (+12 percent cc) ov...

Sandoz Launches Aflibercept Biosimilar Enzeevu in Canada
Sandoz Launches Aflibercept Biosimilar Enzeevu in Canada

Swiss drugmaker Sandoz announced Feb. 2 that it had launched its Eylea biosimilar, branded Enzeevu, in Canada. Enzeevu (aflibercept-abzv) gained approval in Canada in October 2025 for all the refer...

STAAR Names Warren Foust and Deborah Andrews as Interim Co-CEOs Amid Search for Permanent Leader
STAAR Names Warren Foust and Deborah Andrews as Interim Co-CEOs Amid Search for Permanent Leader

STAAR Surgical, of Lake Forest, California, reported Feb. 2 that it had appointed Warren Foust and Deborah Andrews as interim co-CEOs, while the company conducts a global search for a permanent CEO...

Harrow Ends Compounded Product Sales in California, Plans to Sell All Products Under Harrow Label
Harrow Ends Compounded Product Sales in California, Plans to Sell All Products Under Harrow Label

Harrow reported Feb. 2 that it had stopped selling compounded products in California through its ImprimisRx subsidiary on Feb. 1, after settling a disciplinary action brought by the California Boar...

US FDA Gives Green Light to Trial of Life Bio’s Cell Rejuvenation Candidate in Optic Neuropathies
US FDA Gives Green Light to Trial of Life Bio’s Cell Rejuvenation Candidate in Optic Neuropathies

Life Biosciences reported on Jan. 28 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase I trial of ER-100, a cell rejuven...

Santen Gains Approval in Japan for RVL’s Blepharoptosis Drops Under Name Upneeq Mini
Santen Gains Approval in Japan for RVL’s Blepharoptosis Drops Under Name Upneeq Mini

RVL Pharmaceuticals announced Jan. 8 that its partner Santen had gained manufacturing and marketing approval in Japan for RVL’s eye drop formulation of oxymetazoline hydrochloride, to be known in J...

Opus Launches Trial in Abu Dhabi for RP Gene Therapy Candidate
Opus Launches Trial in Abu Dhabi for RP Gene Therapy Candidate

Opus Genetics announced Jan. 27 that it had launched a clinical trial in Abu Dhabi, the capital of the United Arab Emirates, for its gene therapy candidate targeting MERTK-related retinitis pigment...

Merged Southeastern US Eye Banks Will Be Known as Precision Ocular Network
Merged Southeastern US Eye Banks Will Be Known as Precision Ocular Network

Two Southeastern US eye banks, Advancing Sight Network and Miracles In Sight, announced Jan. 27 that their merged operations would be known as Precision Ocular Network. The organizations announced ...

US FDA Grants Orphan Drug Status to BlueRock’s RP Cell Therapy Candidate
US FDA Grants Orphan Drug Status to BlueRock’s RP Cell Therapy Candidate

Bayer subsidiary BlueRock Therapeutics announced Jan. 22 that the US FDA had granted orphan drug status to OpCT-001, its cell therapy candidate for retinitis pigmentosa (RP). Orphan drug designatio...

US FDA Grants Fast Track Status to Drug Farm’s ROSAH Candidate
US FDA Grants Fast Track Status to Drug Farm’s ROSAH Candidate

Drug Farm, of Shanghai, China, announced Jan. 27 that the US FDA had granted fast track designation to DF-003, an oral alpha kinase 1 (ALPK1) inhibitor targeting the rare genetic disease ROSAH synd...

Orbis International Appoints Kathleen Sherwin, MBA, as President and CEO
Orbis International Appoints Kathleen Sherwin, MBA, as President and CEO

Orbis International announced Jan. 12 that it had appointed Kathleen Sherwin as president and chief executive officer. New York-based Orbis said Sherwin brings more than 25 years of experience adva...

US FDA Approves Re-administration of Glaukos’ iDose TR
US FDA Approves Re-administration of Glaukos’ iDose TR

Glaukos announced Jan. 28 that the US FDA had approved a supplement to its new drug application allowing for re-administration of iDose TR, the company’s intracameral travoprost implant for glaucom...

US FDA Approves Tenpoint’s Yuvezzi Drops for Presbyopia
US FDA Approves Tenpoint’s Yuvezzi Drops for Presbyopia

Tenpoint Therapeutics announced Jan. 28 that the US FDA had approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) for presbyopia. The company said it expects to launc...

EU-India Free Trade Agreement to Phase in Lower Pharma and Device Tariffs
EU-India Free Trade Agreement to Phase in Lower Pharma and Device Tariffs

A free trade agreement reached Jan. 27 by the European Union and India will reduce or eliminate tariffs on about 90 percent of goods, including pharmaceuticals and medical devices, between the two ...

US FDA Rolls Out PreCheck Program to Speed Approval of Drug Manufacturing Plants
US FDA Rolls Out PreCheck Program to Speed Approval of Drug Manufacturing Plants

The US FDA announced Jan. 21 that it would begin accepting applications on Feb. 1, 2026, for its new PreCheck Pilot Program to improve the regulatory process for US manufacturing facilities. The ag...

Nidek Launches the Phantom Open-Field Refraction System
Nidek Launches the Phantom Open-Field Refraction System

Japanese company Nidek reported Jan. 26 that it had launched the Phantom Open-Field Refractive System. An open-field system eliminates the traditional phoropter in front of the patient; instead, vi...

US FDA Gives Green Light to Phase II Trial of Novaliq’s Topical Uveitis Candidate
US FDA Gives Green Light to Phase II Trial of Novaliq’s Topical Uveitis Candidate

Germany’s Novaliq reported on Jan. 26 that the US FDA had signed off on its investigational new drug (IND) application, allowing the company to proceed with a Phase II trial of NOV05, its topical, ...

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