Latest Industry News & Trends

Fall of Restasis Weighs on Dry Eye Revenue in 2024

Restasis continued to act as a brake on prescription dry eye pharmaceutical revenue in 2024 as its US sales kept plummeting. AbbVie reported that sales of the one-time blockbuster drug in the US fe...

Eyenovia Scraps Phase III Study of Low-Dose Atropine Candidate in Myopia

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...

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...

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...

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...

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...

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...

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...

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...

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....

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...

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...

AAO Puts FDA Deputy Director of Ophthalmology on the Hot Seat

William Boyd, MD, deputy director of ophthalmology at the US FDA’s Office of New Drugs, had a quick answer when asked to name the biggest unmet need in ophthalmology. “We need and want more therapi...

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...

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...

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...

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...

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...

Spinogenix Unveils Glaucoma Program to Evaluate Once-Daily Neuroprotective Pill

Los Angeles-based Spinogenix reported Oct. 16 that it was launching a program to evaluate SPG302 as a potential neuroprotective therapeutic for glaucoma. Spinogenix describes SPG302 as a once-a-day...

Orasis Licenses Qlosi Presbyopia Drops to Optus in Korea for $18 Million, Plus Royalties

Orasis Pharmaceuticals announced Oct. 16 that it had licensed its Qlosi presbyopia drops to Optus Pharmaceuticals for the Korean market. Under the deal, Optus will pay upfront and milestone payment...

Nicox and Soleus Sign $16.5 Million Deal for Vyzulta Royalties, Equity Financing

France’s Nicox announced Oct. 14 a deal with Soleus Capital under which Soleus will acquire Nicox’ royalties from the glaucoma treatment Vyzulta for $15 million, while providing $1.5 million in equ...

Eyenovia Launches Clobetasol Drops for Postoperative Pain and Inflammation

Eyenovia announced Sept. 26 the US launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, known as Clobetasol, for postoperative inflammation and pain following oc...

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 ...

AbbVie Withdraws EU Marketing Application for Durysta Implant for Glaucoma

Europe’s Committee for Medicinal Products for Human Use (CHMP) announced Sept. 19 that AbbVie had withdrawn its marketing authorization application for the sustained-release glaucoma implant Duryst...

NEI Researchers Identify Protein That Clears Cataracts in Animals

Researchers at the National Eye Institute (NEI), working with counterparts in China, have discovered a reversible cataract response in hibernating squirrels that may point toward a nonsurgical trea...

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...

Eyenovia Launches Clobetasol Drops for Postoperative Pain, Inflammation

Eyenovia announced Sept. 26 the US launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, known as Clobetasol, for postoperative inflammation and pain following oc...

AbbVie Withdraws EU Marketing Application for Durysta

Europe’s Committee for Medicinal Products for Human Use (CHMP) announced Sept. 19 that AbbVie had withdrawn its marketing authorization application for the sustained-release glaucoma implant Duryst...

Tepezza Receives Approval in Japan to Treat Active Thyroid Eye Disease

Amgen reported Sept. 24 that Tepezza had gained approval in Japan for the treatment of active or high clinical activity score thyroid eye disease (TED). The Thousand Oaks, California, company said ...

Amgen’s Pavblu is Fifth Aflibercept Biosimilar to Gain US Approval in 2024

The FDA has approved Amgen’s Pavblu (aflibercept-ayyh), making it the fifth Eylea biosimilar to reach the milestone in the US in 2024. FDA records show Pavblu was approved Aug. 23. Labeling shows i...

Harrow to Add Nearly 150 Jobs as it Continues Expanding in Nashville

Harrow reported Sept. 25 that it is creating nearly 150 new jobs as it expands its corporate headquarters in Nashville, Tennessee. The move follows the company increasing its total leased space in ...

Ripple, AbbVie to Collaborate on Fully Biodegradable Bimatoprost Implant for Glaucoma

Ripple Therapeutics, of Toronto, Canada, announced Sept. 17 that it had signed a collaboration agreement with AbbVie to develop RTC-620, a fully biodegradable sustained-release intracameral bimatop...

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...

Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error

Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...

Visiox to Merge with Ocuvex to Advance Two Ophthalmic Drug Candidates

Visiox Pharmaceuticals announced Aug. 19 that it had agreed to merge with Ocuvex Therapeutics, a privately held company in New Hyde Park, New York. A Visiox news release said Ocuvex has a pipeline ...

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...

Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results

A new analysis of 2008 clinical study data has given a boost to Livionex’ topical drop candidate for cataracts, the John Moran Eye Center reported Aug. 16. The drop, called C-KAD, is a formulation ...

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 (...

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 ...

Oculis Shuts Down Phase III Trial of OCS-01 Due to Third-Party Administrative Error

Swiss company Oculis reported Aug. 27 in its Q2-2024 financial statement that it was shutting down the Phase III OPTIMIZE-2 trial of its OCS-01 eye drop candidate for postsurgical inflammation and ...

European Commission Approves SIFI’s Akantior Drops for Acanthamoeba Keratitis

Italy’s SIFI announced Aug. 26 that the European Commission had approved Akantior (polihexanide 0.08%) drops for the treatment of Acanthamoeba keratitis (AK), a parasitic infection of the eye, in p...

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...

Livionex’ Cataract Drop Candidate to Advance After New Analysis of Study Results

A new analysis of 2008 clinical study data has given a boost to Livionex’ topical drop candidate for cataracts, the John Moran Eye Center reported Aug. 16. The drop, called C-KAD, is a formulation ...

Visiox to Merge with Ocuvex to Advance Candidates for Glaucoma, Postsurgical Pain and Inflammation

Visiox Pharmaceuticals announced Aug. 19 that it had agreed to merge with Ocuvex Therapeutics, a privately held company in New Hyde Park, New York. A Visiox news release said Ocuvex has a pipeline ...

Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser

Eyenovia announced in its Q2-2024 financial results that it planned to seek marketing clearance for an advanced Gen-2 Optejet microdoser. Eyenovia, of New York, said production was expected to begi...

Ocumension Acquires Rights to Alcon Eye Drops in Exchange for Equity Stake

China’s Ocumension Therapeutics announced Aug. 13 that it would acquire or secure Chinese rights to a portfolio of Alcon dry eye treatments and procedural drops. In exchange, Ocumension will issue ...

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...

Ocumension Acquires Rights to Alcon Eye Drops in Exchange for 16.7 Percent Equity Stake

China’s Ocumension Therapeutics announced Aug. 13 that it would acquire or secure Chinese rights to a portfolio of Alcon dry eye treatments and procedural drops. In exchange, Ocumension will issue ...

Santen Licenses Cloudbreak Topical Pterygium Candidate for Japan, Korea, and Southeast Asia

Japan’s Santen announced Aug. 6 that it had signed an agreement to license CBT-001, a topical pterygiumtreatment candidate from Cloudbreak Pharma. The deal covers the territories of Japan, South Ko...

Formosa Licenses Clobetasol Propionate Drops to Apotex for Canada

Taiwan-based Formosa Pharmaceuticals announced Aug. 5 that it had agreed to license to Apotex exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain...

ANI to Acquire Alimera Sciences, Maker of Iluvien and Yutiq, for $381 Million

ANI Pharmaceuticals announced June 24 that it would acquire Alimera Sciences, maker of Iluvien and Yutiq, in a deal worth $381 mil-lion up front. The deal is expected to close in late Q3-2024, the ...

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...

ANI Pharmaceuticals to Acquire Alimera Sciences, Maker of Iluvien and Yutiq, for $381 Million

ANI Pharmaceuticals announced June 24 that it would acquire Alimera Sciences, maker of Iluvien and Yutiq, in a deal worth $381 million up front. The deal is expected to close in late Q3-2024, the c...

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...

Ophthalmic Company Revenue Totals $11 Billion, a Drop of 0.2 Percent, in Q1-2024

Ophthalmic manufacturer revenue in Q1-2024 totaled $11.0 billion. Revenue decreased 0.2 percent from the same quarter in 2023 and dropped 1.7 percent from Q4-2023. The total includes Market Scope e...

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...

Emerging Companies Pursuing Ophthalmic Indications, June 2024

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

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...

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...

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...

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...

Q1-2024 Ophthalmic Revenue Roundup for Alcon, Carl Zeiss Meditec, and Harrow

Alcon reported May 13 that its Q1-2024 net sales were $2.4 billion, a 5 percent increase (+7 percent cc) over $2.3 billion in Q1-2023. Surgical net sales totaled $1.34 billion, consisting of $433 m...

Formosa Licenses Clobetasol Propionate Drops to Tabuk Pharmaceuticals for MENA Region

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...

Outlook Submits UK Marketing Application for Ophthalmic Bevacizumab in Wet AMD

Outlook Therapeutics announced May 13 that it had submitted a marketing authorization application to the UK’s Medicines and Healthcare Products Regulatory Agency for ONS-5010 (bevacizumab gamma) fo...

OcuTerra to Wind Down Operations After Disappointing Phase II Results in DR

OcuTerra Therapeutics, of Boston, Massachusetts, announced May 1 on LinkedIn that it would wind down operations. The company had been developing nesvategrast (OTT166 5%), an eye drop candidate for ...

US FDA Approves Preservative-Free Lumify Drops from Bausch + Lomb

Bausch + Lomb announced April 26 that the US FDA had approved a preservative-free formulation of Lumify redness reliever eye drops. Lumify is an over-the-counter formulation of low-dose brimonidine...

Q1-2024 Ophthalmic Revenue Roundup for Roche, Novartis, and Nicox

Swiss company Roche reported April 24 that Vabysmo sales in Q1-2024 were CHF 847 million ($926.5 million, calculated April 24, 2024), up from CHF 432 million (US $487 million) in Q1-2023. Vabysmo r...

Second Shake-up May be Underway in the Glaucoma Pharmaceuticals Market

Allergan and Novartis replaced Merck and Pfizer at the top of the glaucoma pharmaceuticals market a decade ago. Now it could be their turn to pass the baton. Allergan, acquired by AbbVie in 2020 an...

Viatris, Ocuphire Announce US Launch of Ryzumvi to Reverse Pupil Dilation

Viatris and Ocuphire Pharma announced April 1 the US launch of Ryzumvi (phentolamine ophthalmic solution) 0.75% for the reversal of pharmacologically induced mydriasis. The US FDA approved Ryzumvi ...

Outlook Leads Latest Ophthalmic Fundraising with $164M in Private Placements

Retinal drug developer Outlook Therapeutics led recent ophthalmic fundraising efforts with two private placements, for proceeds totaling $164 million. Financing announced in the past four weeks tot...

Study Attempts to Clarify Best Fit for Vyzulta

Constance Okeke, MD, is helping to clear the confusion that can come from having multiple choices. “There are so many medicines coming into glaucoma that it can be difficult for a clinician to know...

Eyecelerator Celebrates Fourth Anniversary While Showcasing Innovation in Ophthalmology

A nor’easter storm that disrupted many travel itineraries failed to deter the nearly 600 industry personnel and clinicians who attended Eyecelerator ahead of the 2024 ASCRS meeting. This year’s con...

Chambers Retires from US FDA After 36-Plus Years of Ophthalmic Drug Review

Wiley Chambers, MD, an ophthalmologist who conducted or supervised the review of ophthalmic drugs at the US FDA for 36½ years, retired from the agency Jan. 13, 2024. The 65-year-old is now serving ...

Generic Drugmakers Sued by Large Employers in Price Fixing Scheme

Nine large employers—including American Airlines, Aramark, General Motors, Target, and Lowe’s—have filed a new lawsuit against leading makers of generic drugs, claiming the drugmakers have engaged ...

US Accuses Regeneron of Fraudulent Drug Price Reporting for Eylea

The US Justice Department has accused New York-based Regeneron of fraudulently manipulating Medicare’s drug pricing process for Eylea, costing the Medicare system hundreds of millions of dollars. T...

Eyenovia Explores Strategic Alternatives as it Rolls Out Mydcombi, Postsurgical Steroid

Eyenovia reported April 8 that it is exploring strategic alternatives to maximize shareholder value, even as it rolls out Mydcombi for pupil dilation and prepares to launch its clobetasol propionat...

Pravin Dugel, MD, Becomes President, CEO of Ocular Therapeutix

Ocular Therapeutix announced April 15 that its executive chairman, Pravin Dugel, MD, would assume the roles of president and chief executive officer, and that Antony Mattessich is stepping down, ef...

Leading Generic Drugmakers Sued by Large Employers in Price Fixing Scheme

Nine large employers—including American Airlines, Aramark, General Motors, Target, and Lowe’s—have filed a new lawsuit against leading makers of generic drugs, claiming the drugmakers have engaged ...

US Accuses Regeneron of Fraudulent Drug Price Reporting for Eylea

The US Justice Department has accused New York-based Regeneron of fraudulently manipulating Medicare’s drug pricing process for Eylea, costing the Medicare system hundreds of millions of dollars. T...

Eyenovia Explores Strategic Alternatives as it Rolls Out Mydcombi, Postsurgical Steroid

Eyenovia reported April 8 that it is exploring strategic alternatives to maximize shareholder value, even as it rolls out Mydcombi for pupil dilation and prepares to launch its clobetasol propionat...

Nicox Appoints Gavin Spencer, PhD, as Chief Executive Officer

France’s Nicox announced that it had appointed Gavin Spencer, PhD, as chief executive officer, effective Feb. 28. Spencer was most recently executive vice president, chief business officer, and hea...

Chambers Retires from US FDA After 36-Plus Years of Ophthalmic Drug Review

Wiley Chambers, MD, an ophthalmologist who conducted or supervised the review of ophthalmic drugs at the US FDA for 36 1/2 years, retired from the agency Jan. 13, 2024. The 65-year-old is now servi...

2023 Ophthalmic Revenue Roundup for Harrow, Alimera Sciences, and EyePoint

Nashville, Tennessee-based Harrow reported March 19 that its 2023 revenue was $130.2 million, a 47 percent increase over $88.6 million in 2022. The company generated record quarterly revenue in Q4-...

Ophthalmic Company Revenue in Q4-2023 Rises 0.4 Percent

Ophthalmic manufacturer revenue in Q4-2023 totaled $11.2 billion. Revenue increased 0.4 percent from the same quarter in 2022 and increased 1.0 percent from Q3-2023. The total includes Market Scope...

US FDA Approves Clobetasol Propionate Eye Drops for Postsurgical Pain, Inflammation

Taiwan-based Formosa Pharmaceuticals announced March 4 that the US FDA had approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for inflammation and pain following ocular surgery. ...

Santen Files for Marketing Approval in Japan for Atropine Drops to Delay Myopia

Santen Pharmaceutical announced Feb. 28 that it had filed for marketing approval in Japan for DE-127 (0.025% atropine sulfate hydrate eye drop), designed to slow the progression of myopia. The prod...

Celanese Announces Launch of Glaukos’ iDose TR Travoprost Implant

Celanese announced the commercial launch Feb. 29 of Glaukos’ iDose TR intracameral travoprost implant for glaucoma. Celanese, a specialty materials and chemical company based in Dallas, Texas, prod...

NovaBay, Eyenovia Team Up to Co-promote Ophthalmic Products

Eyenovia and NovaBay Pharmaceuticals announced March 13 the signing of a co-promotion agreement to commercialize their prescription ophthalmic products. Under the agreement, NovaBay will market Eye...

US FDA Approves Clobetasol Propionate Eye Drops for Postsurgical Pain, Inflammation

Taiwan-based Formosa Pharmaceuticals announced March 4 that the US FDA had approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for inflammation and pain following ocular surgery. ...

Celanese Announces Commercial Launch of Glaukos’ iDose TR Travoprost Implant

Celanese announced the commercial launch Feb. 29 of Glaukos’ iDose TR intracameral travoprost implant for glaucoma. Celanese, a global specialty materials and chemical company based in Dallas, Texa...

AbbVie Names Robert Michael to Succeed Richard Gonzalez as CEO

AbbVie reported Feb. 20 that it had named Robert A. Michael—the company’s current president and chief operating officer—to succeed Richard A. Gonzalez as chief executive officer. Michael also will ...

Regulators in Singapore Accept NDA from AffaMed for Dextenza

Shanghai-based AffaMed Therapeutics announced Feb. 19 that the Singapore Health Sciences Authority had accepted its new drug application (NDA) for Dextenza (0.4 mg dexamethasone intracanalicular in...

Harrow Licenses Rights to Five Drugs to Apotex for Canada

Harrow reported Feb. 15 that it had licensed to Apotex exclusive marketing and distribution rights to Verkasia and over-the-counter Cationorm Plus in the Canadian market. In addition, Apotex will p...

Nicox Licenses NCX 470 (Bimatoprost) Drop for Glaucoma to Kowa for Japan for $3.2 Million Up Front

France’s Nicox announced Feb. 8 that it had signed a deal granting Japanese drug company Kowa exclusive Japanese rights to develop and commercialize Nicox’ NCX 470 (0.1% bimatoprost) eye drop for g...

Apellis Seeks Re-examination of EU Marketing Application for Pegcetacoplan in GA after Negative CHMP Opinion

Apellis Pharmaceuticals announced Jan. 26 that, as expected, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended refusal of the company’s marketing...

2023 Ophthalmic Revenue Roundup for Roche, Novartis, and Lumibird

Swiss company Roche reported Feb. 1 that global sales of Vabysmo for 2023 were CHF 2.36 billion ($2.78 billion, converted Feb. 1, 2024), a 299 percent increase (+324 percent cc) over CHF 591 millio...

New Company Eyconis Formed to Develop Ascendis Pharma's Ophthalmology Assets

Denmark’s Ascendis Pharma announced Jan. 29 that it had founded Eyconis, a separate company to develop and commercialize its ophthalmic assets globally. The company is launching with a $150 million...

2023 Ophthalmic Revenue Roundup for J&J Vision and Nicox

Johnson & Johnson reported Jan. 23 that its full year 2023 global surgical vision revenue was $1.37 billion, a 4.9 percent increase (+5.8 percent cc) over $1.31 billion in 2022. Revenue was down 1....

BlueRock Exercises Option to License Retinal Cell Therapy Candidate from Fujifilm and Opsis

Bayer subsidiary BlueRock Therapeutics announced Jan. 23 that it had exercised its option to license OpCT-001, an induced pluripotent stem cell (iPSC) derived cell therapy candidate for primary pho...

Abpro to Gain Nasdaq Listing in Merger with SPAC, Has Retinal Candidate in Pipeline

Privately held Abpro reported Jan. 22 that it will gain a listing on the Nasdaq through a merger with Atlantic Coastal Acquisition Corp. II, a special purpose acquisition company (SPAC) based in Ne...

Clinical Trial Updates for Ophthalmic Candidates, January 2024

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

2023 in Review: GA Treatments Burst onto Retinal Pharma Scene—with Hiccups

New drugs to treat geographic atrophy (GA) hit the US market in 2023, but not without controversy. The US FDA approved Syfovre (pegcetacoplan injection) for commercial distribution for the treatmen...

2023 in Review: Two Drugs with New Mode of Action Mark Upheaval in Dry Eye

The US FDA approved a new class of drugs to treat the signs and symptoms of dry eye disease in 2023. Two new treatments in the class, Miebo and Vevye, are both based on perfluorocarbon (PFC) molecu...

2023 in Review: Roche’s Vabysmo Retinal Drug Crosses $1 Billion in Annual Sales

Vabysmo (faricimab), the new drug from Roche for exudative retinal disease that entered the market in 2022, reached “blockbuster” status in 2023. A blockbuster drug is defined as a drug with $1 bil...

US FDA PDUFA Target Action Dates for Ophthalmic Candidates, 2024

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

Quake in Japan Affects Some Ophthalmic Companies, News Outlet Reports

Santen Pharmaceutical, Astellas Pharma, and Nitto Medic were among Japanese ophthalmic drugmakers facing delays in manufacturing drugs in the aftermath of a massive earthquake on New Year’s Day, ne...

Eyenovia Reacquires Rights to MicroPine in US, Canada from Bausch + Lomb

Eyenovia announced Jan. 16 that it had reacquired the rights to pediatric myopia candidate MicroPine in the US and Canada from Bausch + Lomb. The investigational formulation of atropine, intended f...

India Orders Tougher Drug-Making Standards After Overseas Deaths

Prime Minister Narendra Modi’s government has stepped up scrutiny of India’s pharmaceutical factories after being stung by a series of overseas deaths linked to Indian-made drugs. The news agency R...

Amneal Launches Generic Fluorometholone Ophthalmic Suspension

Amneal Pharmaceuticals announced Jan. 10 that it had received US FDA approval for and launched generic fluorometholone eye drops. The product is indicated for the treatment of corticosteroid-respon...

Bayer Receives EU Approval for High-Dose Eylea

German drugmaker Bayer announced Jan. 8 that the European Commission had granted marketing authorization in the EU for high-dose Eylea (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the...

Harrow Launches Dry Eye Drug Vevye in US

Harrow, of Nashville, Tennessee, reported Jan. 11 that dry eye drugVevye is now available in the US. Vevye (cyclosporine ophthalmic solution) 0.1% is a non‑preserved, twice-daily-dosed prescription...

Quake in Japan Affects Some Ophthalmic Companies, News Outlet Reports

Santen Pharmaceutical, Astellas Pharma, and Nitto Medic were among Japanese ophthalmic drugmakers facing delays in manufacturing drugs in the aftermath of a massive earthquake on New Year’s Day, ne...

Ophthalmic Drugmaker Visiox to Merge with SPAC to Gain Nasdaq Listing

Privately held Visiox Pharmaceuticals reported Dec. 27 that it will gain a listing on the Nasdaq through a merger with PowerUp Acquisition Corp., a special purpose acquisition company (SPAC) based ...

Genentech Names Ashley Magargee as CEO

Genentech, a member of the Roche Group, reported Dec. 12 that it had appointed Ashley Magargee as chief executive officer. Magargee has been serving as interim CEO since Alexander Hardy stepped dow...

White House Threatens to Use March-in Rights to Lower Drug Prices

The White House on Dec. 7 rolled out a framework to use the government’s march-in rights on drugs developed with taxpayer dollars, saying if drugmakers refuse to make their products available at an...

Ophthalmic Company Revenue Increases 3.4 Percent in Third Quarter of 2023

Ophthalmic manufacturer revenue in Q3-2023 totaled $11.1 billion. Revenue increased 3.4 percent from the same quarter in 2022 and decreased 2.7 percent from Q2-2023. The total includes Market Scope...

FDA Approves 11 Ophthalmic Drug Products in 2023, Rejects Three More

2023 was a busy year for the US FDA in ophthalmology. Among the 11 drug products approved were the first two therapies in the US to treat geographic atrophy; two new drops for dry eye; and a second...

EyePoint’s Sustained-Release Anti-VEGF Implant for Wet AMD Meets All Endpoints in Phase II

EyePoint Pharmaceuticals reported Dec. 4 that EYP-1901, a sustained-release anti-VEGF implant candidate, met its primary endpoint and all secondary endpoints in the Phase II DAVIO 2 trial in wet ag...

Genentech, Nvidia Combine AI Expertise to Accelerate Drug Development

Genentech and Nvidia reported Nov. 21 that the two companies had formed a multi-year strategic research collaboration to accelerate Genentech’s proprietary algorithms and speed drug development. Ge...

Santen Receives EU Approval for Catiolanze (Preservative-Free Latanoprost) in Glaucoma

Japanese drugmaker Santen Pharmaceutical announced Nov. 17 that the European Commission had approved its marketing authorization application for preservative-free Catiolanze (cationic emulsion of l...

AbbVie Signs Option Deal with Aldeyra for License to Develop Reproxalap

Aldeyra Therapeutics announced Nov. 1 that AbbVie had signed an exclusive option agreement to license to develop, manufacture, and commercialize reproxalap, Aldeyra’s candidate in development for d...

Weekly Surgeon Poll, November 2023

Q3-2023 Ophthalmic Revenue Roundup for Immunocore, Harrow, RxSight, and Three Others

UK-headquartered Immunocore reported Nov. 7 that its Q3-2023 net revenue from Kimmtrak (tebentafusp) was £49.7 million ($60.7 million, converted at a rate of £1.00 to $1.2214), an increase of 9 per...

Kodiak Will Restart its Tarcocimab Program After Strong Results in Phase III DR Trial

Kodiak Sciences announced Nov. 6 that it would restart its tarcocimab tedromer development program after strong positive results from a Phase III trial in diabetic retinopathy (DR). The Palo Alto, ...

Outlook Plans New Clinical Trial for Lytenava After Meeting with US FDA

Outlook Therapeutics reported Nov. 2 that it plans to hold another clinical trial of Lytenava, an ophthalmic formulation of bevacizumab, for wet age-related macular degeneration (AMD), in the wake ...

Q3-2023 Ophthalmic Revenue Roundup for Regeneron, Bausch + Lomb, AbbVie, and Five Others

Regeneron of Tarrytown, New York, reported Nov. 2 that its Q3-2023 US revenue for Eylea (aflibercept) 2 mg and Eylea HD (a higher dose of aflibercept at 8 mg) was $1.49 billion, with Eylea HD accou...

Ocuphire Pharma Appoints George Magrath, MD, as Chief Executive Officer

Ocuphire Pharma announced Nov. 1 that it had appointed George Magrath, MD, as chief executive officer and a member of its board of directors. Magrath succeeds Rick Rodgers, interim CEO and presiden...

Australia’s Opthea Appoints Fred Guerard, PharmD, as US-Based CEO

Australian company Opthea announced Oct. 27 that the company’s chief executive officer, Megan Baldwin, PhD, will transition to founder and chief innovation officer, and that US-based Frederic Guera...

Q3-2023 Ophthalmic Revenue Roundup for Roche, Novartis, J&J Vision, and Nicox

Swiss company Roche reported Oct. 19 that Q3-2023 Vabysmo sales were CHF 656 million ($732 million, converted Oct. 19), a 309 percent increase over CHF 173 million in Q3-2022. Vabysmo was approved ...

US FDA Approves Genentech’s Vabysmo for Retinal Vein Occlusion

Genentech, a member of the Roche Group, announced Oct. 27 that the US FDA had approved Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the...

Stuart Therapeutics Licenses its Glaucoma Neuroprotection Candidate to Glaukos

Stuart Therapeutics announced Oct. 18 that it had granted Glaukos exclusive worldwide rights to develop and commercialize Stuart’s ST-113 drug candidate for neuroprotection in glaucoma. ST-113 is a...

US FDA Clears IND for Trial of Endogena’s RPE Regeneration Candidate in GA

Swiss company Endogena Therapeutics announced Oct. 24 that the US FDA had cleared its investigational new drug (IND) application for a clinical trial of EA-2351, a regenerative treatment candidate ...

EMA Grants PRIME Designation to 4DMT’s 4D-150 Gene Therapy Candidate in Wet AMD

4D Molecular Therapeutics announced Oct. 23 that the European Medicines Agency had granted Priority Medicine (PRIME) designation for 4DMT’s intravitreal gene therapy candidate 4D-150 in wet age-rel...

EMA Grants PRIME Designation to Annexon’s ANX007 IVT Candidate for GA

Annexon announced Oct. 24 that the European Medicines Agency had granted Priority Medicine (PRIME) designation to ANX007 for the treatment of geographic atrophy (GA) secondary to age-related macula...

Roche Drops Development of Oral Drug Candidate for DR

Swiss drugmaker Roche reported in its Q3-2023 earnings call on Oct. 19 that it had ended development of vicasinabin (RG7774), an oral candidate for non-proliferative diabetic retinopathy, after com...

Novartis Spins Out Sandoz, a Leading Provider of Generic Ophthalmic Drugs

Swiss company Novartis spun out Sandoz, its generics and biosimilars business, on Oct. 4. Sandoz is a leading provider in the US of generic ophthalmic drugs for a wide range of eye diseases. It has...

US FDA Approves Presbyopia Drop Qlosi from Orasis

Orasis Pharmaceuticals announced Oct. 18 that the US FDA had approved Qlosi (pilocarpine hydrochloride 0.4%), a twice-daily eye drop for presbyopia. The company said it expected Qlosi, a preservati...

Padagis Launches Generic Brinzolamide Drop for Glaucoma

Specialty pharma company Padagis announced Oct. 13 the launch of its brinzolamide ophthalmic suspension, a generic version of Novartis’ Azopt for glaucoma. Padagis with offices in the US and Israel...

First Patient Dosed in Phase III Trial of Innovent’s Anti-VEGF, Anti-Complement Candidate for Wet AMD

China’s Innovent Biologics announced Oct. 8 that the first patient had been dosed in a Phase III trial of efdamrofusp alfa (IBI302), a recombinant fully human anti-VEGF and anti-complement bispecif...

Pine Pharmaceuticals Recalls Ophthalmic Drug Products Produced at 503B Facility

Pine Pharmaceuticalsannounced Oct. 2 that it had issued two voluntary recalls of drug products that include ophthalmic drugs. Repackaged bevacizumab appears to be the most affected ophthalmic produ...

Melt Gains Exclusive License to Catalent’s Fast-Dissolve Technology with Certain Sedation Ingredients

Melt Pharmaceuticals announced Sept. 26 that it had entered into an exclusive development and license agreement with Catalent to use Catalent’s Zydis orally disintegrating tablet with MELT-300, a s...

US FDA Approves Ryzumvi from Viatris and Ocuphire for Reversal of Mydriasis

Viatris and Ocuphire Pharma announced Sept. 27 that the US FDA had approved Ryzumvi (phentolamine ophthalmic solution) 0.75% for the reversal of pharmacologically induced mydriasis. Ryzumvi is expe...

Théa Launches Preservative-Free Iyuzeh (Latanoprost) for Glaucoma in the US

Théa Pharma, the US subsidiary of France’s Laboratoires Théa, announced the launch Sept. 26 of once-daily Iyuzeh (latanoprost ophthalmic solution) 0.005% in the US market. Iyuzeh is the first prese...

Two-Year Results for Izervay Show Continued Slowing of GA Growth

Iveric Bio, an Astellas company, reported on Sept. 18 positive 24-month topline results from the Phase III GATHER2 trial of Izervay (avacincaptad pegol), its treatment for geographic atrophy (GA) s...

Mati Completes Facility to Manufacture Evolute Punctal Plug Portfolio

Mati Therapeutics, of Austin, Texas, reported Sept. 12 that it had completed a 10 thousand square foot facility in Bryan, Texas, to manufacture the company’s Evolute sustained drug delivery platfor...

Novartis Readies Spinout of Sandoz, a Leading Provider of Generic Ophthalmic Drugs

Swiss company Novartis reported Sept. 15 that its shareholders had approved its spinoff of Sandoz, its generics and biosimilars business. The target date for the spinoff is Oct. 4. Sandoz is a lead...

Precision Dropper Aims for Greater Patient Comfort, Less Waste

Precision Dropper, of Twin Falls, Idaho, on Sept. 15 introduced its universal adapter for eye drop bottles, designed to increase patient comfort and reduce waste when administering topical ocular m...

Brim Leads Latest Ophthalmic Fundraising with $45.8 Million Rights Issue

Brim Biotechnologies, of Taiwan, led recent ophthalmic fundraising efforts with a $45.8 million rights issue to advance its lead dry eye candidate. Funding announced in the past four weeks totaled ...

Syfovre, Acthar Gel Receive J-Codes, While Luminopia Gets A-Code

The Centers for Medicare & Medicaid Services (CMS) issued J-codes in Q2-2023 for Syfovre and Acthar Gel and an A-code for Luminopia’s software for amblyopia treatment. The billing codes take effect...

Apotex Launches Brimonidine Tartrate 0.1% Ophthalmic Solution in US

Apotex announced Sept. 5 that it had launched its generic brimonidine tartrate 0.1% ophthalmic solution in the US. Brimonidine is an alpha-adrenergic receptor agonist indicated for the reduction of...

No Ophthalmic Drugs on List for Medicare Price Negotiation

No ophthalmic pharmaceutical or biologic product made the list of US Medicare Part D drugs subject to price negotiations in 2026. The White House published the list on Aug. 29. Most ophthalmic drug...

Apotex Launches Brimonidine Tartrate 0.1% Ophthalmic Solution in US

Apotex announced Sept. 5 that it had launched its generic brimonidine tartrate 0.1% ophthalmic solution in the US. Brimonidine is an alpha-adrenergic receptor agonist indicated for the reduction of...

US FDA Declines to Approve Outlook’s Ophthalmic Formulation of Bevacizumab for Wet AMD

Outlook Therapeutics reported on Aug. 30 that the US FDA had issued a complete response letter to the company’s biologics license application (BLA) for Lytenava, an ophthalmic formulation of bevaci...

US FDA Approves High-Dose Aflibercept from Regeneron for Wet AMD, DME, and DR

Regeneron Pharmaceuticals announced Aug. 18 that the US FDA had approved Eylea HD, its high-dose formulation of aflibercept, for wet age-related macular degeneration (AMD), diabetic macular edema (...

Apellis Issues Syfovre Safety Update, Recommends Not Using 19-Gauge Filter Needle in Certain Kits

Apellis Pharmaceuticals issued a safety update Aug. 22 regarding cases of rare, vision-threatening retinal vasculitis associated with injections of Syfovre (pegcetacoplan injection), its treatment ...

US FDA Approves Generic Bromfenac Drops from India’s Lupin for Postsurgical Pain and Inflammation

Indian drugmaker Lupin announced Aug. 16 that the US FDA had approved its abbreviated new drug application for bromfenac ophthalmic solution, 0.09%, a generic equivalent of Bausch + Lomb’s Bromday....

No Eye Drug Expected Among Initial Drugs Set for Medicare Price Negotiation

Ophthalmic drugs are not expected to make the list of drugs subject to US Medicare price negotiations in 2026 or 2027, according to a study published in March 2023 by the Journal of Managed Care & ...

US FDA Approves Xdemvy Eye Drops from Tarsus for Demodex Blepharitis

Tarsus Pharmaceuticals announced July 25 that the US FDA had approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. Xdemvy, formerly known as TP-03, is the ...

US FDA Approves Izervay IVT Injection from Iveric Bio for GA

Iveric Bio, an Astellas company, announced Aug. 4 that the US FDA had approved Izervay (avacincaptad pegol) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneratio...

Kriya Leads Latest Ophthalmic Fundraising with $150 Million in Series C

Kriya Therapeutics led recent ophthalmic fundraising efforts with $150 million in a Series C financing to advance its gene therapy candidates. Funding announced in the past four weeks totaled $456....

Clinical Trial Updates for Ophthalmic Candidates, August 2023

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

New Product Launches Confirm Opportunities in Retinal Pharmaceuticals

Two recent drug launches show that there still is plenty of opportunity for new products in retinal pharmaceuticals despite the dominance of Eylea in exudative retinal disease. Vabysmo sales took o...

August 2023 Ophthalmic News Briefs

New York’s Icahn School of Medicine at Mount Sinai announced July 5 that it had launched the Center for Ophthalmic Artificial Intelligence and Human Health. The center will incorporate AI into educ...

EMA Accepts Marketing Application for Geographic Atrophy Candidate from Iveric Bio

Iveric Bio, an Astellas company, announced Aug. 18 that the European Medicines Agency (EMA) had accepted for review its marketing authorization application for avacincaptad pegol, a complement C5 i...

Q2-2023 Ophthalmic Revenue Roundup for Alcon, Immunocore, Harrow, and Two Others

Alcon reported Aug. 15 that its Q2-2023 net sales totaled $2.4 billion, a 9 percent increase (+12 percent cc) over $2.2 billion in Q2-2022. Surgical net sales for implantables, consumables, and equ...