Latest Industry News & Trends

US FDA Approves Lenz’ Vizz (Aceclidine) Drops for Presbyopia

Lenz Therapeutics announced July 31 that the US FDA had approved Vizz (aceclidine ophthalmic solution) 1.44% for presbyopia. The company said Vizz was the first once-daily, preservative-free eye dr...

Boehringer Ingelheim and Re-Vana Sign Potential $1 Billion Collaboration Deal

Boehringer Ingelheim and Re-Vana Therapeutics will collaborate to develop extended-release therapies for eye diseases in a deal worth potentially more than $1 billion for Re-Vana, the companies ann...

Alcon Launches Tryptyr (Acoltremon) Drops for Dry Eye in US

Alcon announced July 29 the US commercial availability of Tryptyr (acoltremon ophthalmic solution) 0.003% to treat the signs and symptoms of dry eye. Tryptyr is a first-in-class TRPM8 agonist, dose...

New Minnesota Law Expands ODs’ Authority to Prescribe Drugs, Perform Injections

A new law passed in Minnesota expands optometrists’ authority to prescribe certain medications and allows them to administer some in-office injections. The Minnesota Optometric Association (MOA) ha...

Exonate Plans Phase IIb Trial of Retinal Eye Drop Candidate in NPDR

British company Exonate announced July 29 that it planned a Phase IIb clinical trial for lead compound EXN407, an eye drop candidate targeting retinal vascular diseases, in patients with non-prolif...

Novartis Reports Q2-2025 Lucentis Revenue of $173 Million

Novartis reported July 17 that its Q2-2025 Lucentis revenue outside the US was $173 million, a 37 percent decline (-39 percent cc) from $275 million in Q2-2024. The Swiss company said sales decline...

Onconetix to Merge with Glaucoma Drop Maker Ocuvex

Onconetix, of Cincinnati, Ohio, announced July 16 a definitive merger agreement with Ocuvex, maker of Omlonti (omidenepag isopropyl 0.002%) drops for glaucoma. The combined company will carry the O...

Outlook Therapeutics Appoints Bob Jahr as CEO

Outlook Therapeutics announced July 1 that it had appointed Bob Jahr as chief executive officer. Jahr will also take a seat on Outlook’s board, the company said. Lawrence A. Kenyon, who had served ...

ForSight Leads Latest Ophthalmic Fundraising with $125 Million in Series B

Israel’s ForSight Robotics led recent ophthalmic fundraising efforts with $125 million in Series B funding as it prepares its robotic cataract surgery system for human trials. Financing announced i...

EyeDura Wins Two Octane Awards for Sustained-Release Eye Drop Platform

EyeDura Therapeutics earned the judges’ top award during Octane’s capital and growth company presentations, which spotlighted early-stage, high-potential ophthalmic ventures. The company was a favo...

Weekly Surgeon Poll, July 2025

July 2025 Ophthalmic News Briefs

Hoya Vision Care announced June 2 that it had acquired Centennial Optical, a Canadian distributor of ophthalmic frames, eyeglass lenses, sunglasses, lab supplies, and optical accessories. Financial...

Clearside Explores Strategic Alternatives, Transitions Workforce

Clearside Biomedical reported July 17 that it was exploring strategic alternatives to continue advancing its suprachoroidal space delivery platform and ophthalmic pipeline, while transitioning all ...

Kowa Licenses Nicox’ Glaucoma Drop for US, Other Territories in $222 Million Deal

France’s Nicox announced July 17 that Japan’s Kowa had licensed its glaucoma candidate, NCX 470 (0.1% bimatoprost), for the US and all other unlicensed territories in a deal worth up to €191.5 mill...

EyeDura and its Eye Drop Platform Continue to Win Honors from Accelerators

EyeDura Therapeutics reported July 15 that the company had earned the Judges’ Choice and People’s Choice awards at the Octane Ophthalmology Tech Forum, held June 27 in Newport Beach, California. Th...

Israel’s PainReform Enters Ophthalmology with Investment in LayerBio

Israel’s PainReform announced July 10 that it had signed a strategic agreement with LayerBio, which is developing OcuRing-K, a sustained-release intraocular implant designed to deliver anti-inflamm...

Amneal Gains US FDA Approval for Generic Prednisolone Acetate Eye Drop

Amneal Pharmaceuticals announced June 12 that it had received US FDA approval for its generic prednisolone acetate ophthalmic suspension, 1%, which references AbbVie’s Pred Forte. The sterile, topi...

Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes

Materials company W.L. Gore & Associates announced June 3 the commercial launch of its 0.5 mL silicone-free Improject syringe plunger. The new plunger is specifically designed for prefilled syringe...

ARVO Showcases Manufacturers Looking to Refine Ocular Injections

Big ideas typically dominate the headlines, such as AI, gene therapy, or oculomics, but innovation also happens in small things. The 2025 ARVO meeting displayed a surprising amount of attention to ...

EVs in Ophthalmology Are All About Disease, Not Driving

EVs are having a moment in ophthalmology, and it has nothing to do with Elon Musk. The EVs that are riveting observers in ophthalmology are extracellular vesicles, and according to Sun Young Lee MD...

Harrow Acquires US Rights to Formosa’s Clobetasol, Now Branded Byqlovi

Harrow announced June 9 that it had acquired the US commercial rights to Formosa Pharmaceuticals’ clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain. According to a filing...

US FDA Aims to Speed Drug Review to Under Two Months With New Voucher Program

The US FDA reported June 17 the launch of a new priority review voucher program designed to review prescription drug applications within one to two months of submission. The current average is 10 t...

Regeneron Declines to Submit New Bid for 23andMe After Higher Offer from Co-founder

Drugmaker Regeneron has declined to submit a new bid for genetic testing company 23andMe, a company spokesperson told Reuters on June 16. 23andMe reported June 13 that TTAM Research Institute, a no...

Aldeyra Resubmits NDA to US FDA for Reproxalap in Dry Eye

Aldeyra Therapeutics announced June 17 that it had resubmitted its new drug application (NDA) to the US FDA for topical ocular reproxalap in dry eye. Aldeyra reported in May that reproxalap achieve...

Harrow Acquires US Rights to Formosa’s Clobetasol, Now Branded Byqlovi

Harrow announced June 9 that it had acquired the US commercial rights to Formosa Pharmaceuticals’ clobetasol propionate 0.05% eye drops for postsurgical inflammation and pain. According to a filing...

Spain’s Faes Farma Acquires Italy’s SIFI in Deal Worth $310.4 Million

Faes Farma, of Bilbao, Spain, announced June 11 that it had signed an agreement to acquire 100 percent of Italian ophthalmic company SIFI. The deal values SIFI at €270 million (US $310.4 million, c...

Qlaris Bio Will Advance Fixed-Dose Combo Therapy for Glaucoma with QLS‑111 and Latanoprost

Qlaris Bio announced June 11 that it is developing a preservative-free, fixed-dose combination therapy with its lead asset, QLS-111, and latanoprost, a common prostaglandin analog prescribed for gl...

FDA Begins Listening Tour with Pharma CEOs to Improve Regulatory Process

The US FDA is holding a listening tour, led by FDA Commissioner Marty A. Makary, MD, MPH,to meet directly with pharmaceutical and biotech CEOs, according to an announcement on May 28. The goal is t...

Outlook Launches Lytenava (Bevacizumab) in Germany, UK for Wet AMD

Outlook Therapeutics announced June 2 that it had launched Lytenava (bevacizumab gamma) in Germany and the UK for the treatment of wet age-related macular degeneration (AMD). The company said it wa...

23andMe Seeks New Bids after $305 Million Offer from its Co-founder

Bankrupt genetic testing company 23andMe told a US judge that it wants to reopen bidding on its assets after receiving a $305 million offer from its co-founder Anne Wojcicki, Reuters reported June ...

Gore Launches Silicone-Free Plunger for Ophthalmic Prefilled Syringes

Materials company W.L. Gore & Associates announced June 3 the commercial launch of its 0.5 mL silicone-free Improject syringe plunger. The new plunger is specifically designed for prefilled syringe...

US FDA Approves Alcon’s Tryptyr (Acoltremon) Drops for Dry Eye

Alcon announced May 28 that the US FDA had approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of the signs and symptoms of dry eye. The company ...

Formosa Licenses Clobetasol Drops to Adalvo for European, Brazilian Markets

Taiwan-based Formosa Pharmaceuticals announced May 28 that it had agreed to license to Malta’s Adalvo Limited exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical infla...

Regeneron Buys 23andMe, Says Move will Strengthen its Genetics-Guided Drug Development

Regeneron, of Tarrytown, New York, reported May 19 that it had been named the successful bidder in a bankruptcy auction for the assets of 23andMe, a company that provides direct-to-consumer genetic...

US FDA Approves Genentech’s Susvimo Refillable Implant for DR

Genentech, a member of the Roche Group, announced May 22 that the US FDA had approved Susvimo, a refillable ranibizumab implant, for diabetic retinopathy (DR). The South San Francisco, California, ...

Two AI-Driven Drug Discovery Firms Win 2025 Astellas Future Innovator Prize

Two AI-driven drug discovery companies—DeepSeq.AI and Serna Bio—have won the 2025 Astellas Future Innovator Prize. The accelerator competition, in its sixth year, is offered by drugmaker Astellas P...

US FDA Grants Breakthrough Status to Belite Bio’s Oral Stargardt Candidate

Belite Bio announced May 21 that the US FDA had granted breakthrough therapy status to tinlarebant, an oral tablet targeting Stargardt disease. Sponsor companies receiving breakthrough designation ...

Competition from Generics, Strong Dollar Shape the Global Glaucoma Pharma Market

Generic competition and a strong dollar continue to batter manufacturers’ revenue in the global glaucoma pharmaceuticals market. Companies are reacting to the challenges in diverse ways. Divestment...

Weekly Surgeon Poll, May 2025

May 2025 Ophthalmic News Briefs

London’s Okyo Pharma announced April 30 that it would accelerate development of topical urcosimod, formerly OK-101, in neuropathic corneal pain, following early closure of its Phase II trial. The t...

Formosa Licenses Clobetasol Propionate Drops to Chile’s Saval for Latin America

Taiwan-based Formosa Pharmaceuticals announced April 25 that it had agreed to license to Chile’s Laboratorios Saval exclusive rights to market clobetasol propionate 0.05% eye drops for postsurgical...

US FDA Rejects Regeneron’s sBLA for Eylea HD Dosing Interval Beyond 16 Weeks

Regeneron announced April 18 that the US FDA had issued a complete response letter rejecting the company’s supplemental biologics license application (sBLA) to add extended dosing intervals up to e...

PDUFA Dates for Ophthalmic Drug Candidates, April 2025

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

Retina Pharma and Premium IOLs Continue to Drive Ophthalmic Market

The ophthalmology industry produced an estimated $48.8 billion in revenue in 2024, with an expected compound annual growth rate (CAGR) of 4.5 percent. Market Scope estimates the industry will reach...

Clinical Trial Updates for Ophthalmic Candidates, April 2025

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

Job and Funding Cuts in US HHS Department Hit Ophthalmic Community

The Trump administration’s overhaul of the US Health and Human Services Department (HHS) through mass firings, funding cuts, and restructuring continues to affect those working to protect vision. J...

April 2025 Ophthalmic News Briefs

Carl Zeiss Meditec announced March 21 the availability in Canada of the Visulas Combi, a green and YAG ophthalmic laser workstation combining photodisruption, photocoagulation, and slit lamp techno...

US FDA Accepts Outlook’s Resubmitted BLA for Lytenava, Sets PDUFA Date of Aug. 27

Outlook Therapeutics announced April 8 that the US FDA had accepted the resubmitted biologics license application (BLA) for ONS-5010 (bevacizumab-vikg, Lytenava), an ophthalmic formulation of bevac...

Chinese Regulators Approve Tapcom Fixed-Combo Glaucoma Drop from Santen

Japan’s Santen announced April 4 that China’s National Medical Products Administration had approved the marketing authorization application for Tapcom (tafluprost 0.0015%/timolol maleate 0.5% ), a ...

Onconetix Signs Letter of Intent for Potential Business Combination with Ocuvex

Onconetix, of Cincinnati, Ohio, announced April 8 that it had signed a non-binding letter of intent contemplating a potential business combination with Ocuvex, maker of Omlonti (omidenepag isopropy...

Eyenovia Weighs Potential All-Stock Reverse Merger with Betaliq

Eyenovia, of New York, reported March 20 that it was contemplating an all-stock reverse merger with Betaliq, of Tampa, Florida. The new, publicly listed company would combine Betaliq’s EyeSol water...

Cipla to Market Clobetasol Drops in 11 Countries, Including India, Under License with Formosa

Indian company Cipla has obtained exclusive rights to market clobetasol propionate eye drops in 11 countries, including India, for inflammation and pain following ocular surgery under a license agr...

US FDA Accepts NDA for Sydnexis’ Low-Dose Atropine for Myopia, Sets PDUFA Date of Oct. 23, 2025

Sydnexis, of Del Mar, California, reported March 11 that the US FDA had accepted its new drug application for SYD-101, a low-dose atropine eye drop to slow the progression of pediatric myopia. The ...

G360’s New Horizons Forum Highlights Innovations and Discusses the Future of Glaucoma Therapy

The Glaucoma 360 New Horizons Forum provided an update on technologies with high interest, as well as devices just gaining attention. The forum was held Feb. 7 in San Francisco, California, and dre...

US FDA Approves Expanded Label for Izervay to Extend Treatment for GA Beyond 12 Months

Japan’s Astellas Pharma announced Feb. 12 that the US FDA had approved expanded labeling for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy (GA), extending the allowed du...

2024 and Quarterly Ophthalmic Revenue Roundup for Regeneron, Carl Zeiss Meditec, Hoya, and STAAR

Regeneron, of Tarrytown, New York, reported Feb. 4 that its 2024 US revenue for Eylea 2 mg (aflibercept 2 mg) and Eylea HD (aflibercept 8 mg) totaled nearly $5.97 billion, a 1 percent increase over...

Harrow, Cencora Partner to Improve Drug Access for Retina Specialists, Patients

Drugmaker Harrow reported Jan. 27 that it had partnered with Cencora to launch a program called “Harrow Cares,” with the goal of making Harrow products iHeezo and Triesence more accessible and affo...

Chinese Regulators Accept Marketing Application for Zhaoke’s Low-Dose Atropine Drop for Myopia

Vyluma announced Jan. 29 that China’s National Medical Products Administration had accepted the marketing application from Zhaoke Ophthalmology for NVK002 (low-dose atropine 0.01%) targeting myopia...

2024 Ophthalmic Revenue Roundup for J&J Vision, Lumibird, and Nicox

Johnson & Johnson reported Jan. 22 that its full year 2024 global surgical vision revenue was $1.41 billion, a 3.2 percent increase (+4.3 percent cc) over $1.37 billion in 2023. Revenue was down 3....

Outlook Reports Final Results of Lytenava Trial, Plans BLA Resubmission in Q1-2025

Outlook Therapeutics reported Jan. 16 the final results of the NORSE EIGHT trial of ONS-5010 (Lytenava), an ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD). ONS...

Arctic Vision Gains Approval of Arcatus (Xipere) for Uveitic Macular Edema in Australia, Singapore

Clearside Biomedical announced Jan. 22 that its Asia-Pacific partner, Arctic Vision, had gained approval in Australia and Singapore for Arcatus, known as Xipere in the US, for uveitic macular edema...

Senju Files for Marketing Approval of Dry Eye Candidate SJP-0132 in Japan

Japan’s Senju Pharmaceutical announced Jan. 17 that it had submitted a marketing application in Japan for SJP-0132, a TRPV1 antagonist eye drop candidate targeting dry eye. TRPV1 antagonists have a...

2024 in Review: Complement Therapies for GA Fall Short in Bid for Approval in EU

Apellis Pharmaceuticals and Astellas Pharma were unable to build on their regulatory wins in the US to get a victory in Europe. The European Medicines Agency’s Committee for Medicinal Products for ...

Weekly Surgeon Poll, January 2025

Unity Biotechnology Appoints Federico Grossi, MD, PhD, as Chief Medical Officer

Unity Biotechnology announced Jan. 6 that it had appointed Federico Grossi, MD, PhD, as chief medical officer. Grossi was most recently chief medical officer at Apellis Pharmaceuticals, where he he...

Roche’s Vabysmo Prefilled Syringe Approved in EU for Wet AMD, DME, and RVO

Swiss drugmaker Roche announced Dec. 13 that the European Medicines Agency had approved the Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe for wet age-related macular degeneration (AMD), ...

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...