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Lenz Launches Vizz Drops for Presbyopia in US
Lenz Launches Vizz Drops for Presbyopia in US

Lenz Therapeutics announced Sept. 30 that Vizz (aceclidine ophthalmic solution) 1.44% for presbyopia is now commercially available in the US. The company said its sales force was distributing sampl...

Kala to Shut Down Eye Drop Program for Corneal Defect After Phase IIb Failure
Kala to Shut Down Eye Drop Program for Corneal Defect After Phase IIb Failure

Kala Bio reported Sept. 29 that it would cease development of lead asset KPI-012 and end its mesenchymal stem cell secretome program after the eye drop candidate failed to reach its primary endpoin...

Outlook Meets with US FDA, Plans to Resubmit BLA for Lytenava This Year
Outlook Meets with US FDA, Plans to Resubmit BLA for Lytenava This Year

Outlook Therapeutics reported Sept. 29 that it had met with the US FDA regarding its latest rejection of the company’s biologics license application (BLA) for Lytenava, an ophthalmic formulation of...

Harrow Agrees to Reacquire Melt Pharmaceuticals
Harrow Agrees to Reacquire Melt Pharmaceuticals

Harrow, of Nashville, Tennessee, reported Sept. 26 that it had agreed to reacquire Melt Pharmaceuticals, a clinical stage company developing sedation and analgesia medicines for short-duration medi...

Klotho Agrees to Acquire Turn Bio’s Technology Designed to Restore Cell Function
Klotho Agrees to Acquire Turn Bio’s Technology Designed to Restore Cell Function

Klotho Neurosciences reported Sept. 30 that it had signed a letter of intent to acquire select assets from Mountain View, California-based Turn Biotechnologies. Details of the proposed cash and sto...

Visufarma Becomes Part of India’s Lupin Limited
Visufarma Becomes Part of India’s Lupin Limited

Visufarma BV, of the Netherlands, will become part of India-based Lupin Limited following Visufarma’s acquisition by a Lupin subsidiary. Visufarma has been owned by GHO Capital Partners, of London,...

STAAR Counters Opposition to Alcon Acquisition
STAAR Counters Opposition to Alcon Acquisition

STAAR Surgical reported Sept. 26 that its second largest active stockholder, Soleus Capital Master Fund, with 6 percent of outstanding shares, intends to vote in favor of Alcon’s acquisition of STA...

US FDA Accepts Idebenone NDA for Priority Review, Sets PDUFA Date of Feb. 28, 2026
US FDA Accepts Idebenone NDA for Priority Review, Sets PDUFA Date of Feb. 28, 2026

Chiesi announced Sept. 22 that the US FDA had accepted its new drug application (NDA) for oral idebenone to treat Leber hereditary optic neuropathy (LHON). Regulators set a Prescription Drug User F...

Regulators in Japan Approve Aflibercept (Eylea) Biosimilar from Alvotech and Fuji
Regulators in Japan Approve Aflibercept (Eylea) Biosimilar from Alvotech and Fuji

Iceland’s Alvotech announced Sept. 19 that its commercialization partner in Japan, Fuji Pharma, has received marketing approval for AVT06, a biosimilar to Eylea (aflibercept), from the Japanese Min...

Alcon and BVI Launch New Vitrectomy Systems at Euretina Congress in Paris
Alcon and BVI Launch New Vitrectomy Systems at Euretina Congress in Paris

Equipment manufacturers launched new vitrectomy systems or instruments at the 2025 Euretina congress, held Sept. 4-7 at the Palais des Congrès in Paris. They had a large audience. Euretina set an a...

Topcon Launches Tera Imager for Detection and Management of Dry Eye
Topcon Launches Tera Imager for Detection and Management of Dry Eye

Topcon Healthcare announced Sept. 18 the launch of its Tera Dry Eye Imager, a multimodal platform designed to detect, grade, and manage dry eye disease. Topcon said Tera pairs automation with high-...

Horizon Surgical Systems Names Rajesh Rajpal, MD, as CMO, CSO
Horizon Surgical Systems Names Rajesh Rajpal, MD, as CMO, CSO

Horizon Surgical Systems, of Malibu, California, announced Sept. 23 that it appointed Rajesh K. Rajpal, MD, as its chief medical officer (CMO) and chief strategy officer (CSO). Horizon is developin...

NEI Awards U. of Houston Researchers $3.6 Million to Investigate Vision-Critical Gene
NEI Awards U. of Houston Researchers $3.6 Million to Investigate Vision-Critical Gene

A research team at the University of Houston was awarded more than $3.6 million from the National Eye Institute to investigate a gene that causes blinding retinal diseases when mutated. When workin...

Amneal Gains US FDA Approval for Generic Bimatoprost 0.01% Eye Drop
Amneal Gains US FDA Approval for Generic Bimatoprost 0.01% Eye Drop

Amneal Pharmaceuticals announced Sept. 23 that it had received US FDA approval for its generic bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL, and 7.5 mL), which references AbbVie’s Lumigan. B...

US FDA Grants Fast Track Status to Sanofi’s Wet AMD Gene Therapy Candidate
US FDA Grants Fast Track Status to Sanofi’s Wet AMD Gene Therapy Candidate

France’s Sanofi announced Sept. 11 that the US FDA had granted fast track designation to SAR402663, a one-time IVT gene therapy candidate for wet age-related macular degeneration. SAR402663 deliver...

Ophthalmic Company Revenue Down 1.9 Percent in Q2-2025 as Multiple Firms Report Declines
Ophthalmic Company Revenue Down 1.9 Percent in Q2-2025 as Multiple Firms Report Declines

Ophthalmic manufacturer revenue in Q2-2025 totaled $11.7 billion. Revenue decreased 1.9 percent from the same quarter in 2024 and increased 6.3 percent from Q1-2025. The total includes Market Scope...

Ophthalmologists Report 2.2 Percent Increase in Q2-2025 Procedure Volume
Ophthalmologists Report 2.2 Percent Increase in Q2-2025 Procedure Volume

US ophthalmologists reported that ophthalmic procedures increased 2.2 percent in Q2-2025 compared with the same quarter in 2024, according to Market Scope’s latest survey. Year-over-year performanc...

Annexon Aims to Make Difference in GA by Focusing on Neuroprotection
Annexon Aims to Make Difference in GA by Focusing on Neuroprotection

Excitement is growing around vonaprument (previously called ANX007), the drug that Annexon Biosciences is developing to treat geographic atrophy (GA). The international Phase III trial of the poten...

AI Integration and Workflow Consolidation Drive Diagnostic Innovation
AI Integration and Workflow Consolidation Drive Diagnostic Innovation

After years of steady hardware development, the ophthalmic diagnostic market is now oriented around two strategic imperatives: deep integration of artificial intelligence (AI) and consolidation of ...

New World Medical Launches ClearPath ST with Smaller Tube Lumen
New World Medical Launches ClearPath ST with Smaller Tube Lumen

New World Medical (NWM) announced Sept. 2 that it had launched the Ahmed ClearPath ST glaucoma drainage device, featuring a smaller tube lumen, or diameter. NWM, of Rancho Cucamonga, California, sa...

Ciliatech’s Intercil Uveal Spacer for Glaucoma Gains CE Marking; Already Cleared in UK
Ciliatech’s Intercil Uveal Spacer for Glaucoma Gains CE Marking; Already Cleared in UK

France’s Ciliatech announced Aug. 27 that European regulators had granted CE marking for the Intercil Uveal Spacer, a surgical implant for glaucoma. The Intercil, also known as the cilioscleral int...

Regulatory Panel in Japan Recommends Izervay for Approval in GA
Regulatory Panel in Japan Recommends Izervay for Approval in GA

A Japanese panel has recommended approval for Astellas Pharma’s avacincaptad pegol (known in the US as Izervay) to slow the progression of geographic atrophy (GA), according to a Pharma Japan repor...

Kriya Leads Latest Ophthalmic Fundraising with $320 Million in Series D
Kriya Leads Latest Ophthalmic Fundraising with $320 Million in Series D

Kriya, of Durham, North Carolina, led recent ophthalmic fundraising efforts with a $320 million Series D round to fund its pipeline of gene therapy candidates. Financing announced in the past four ...

US FDA Again Rejects Outlook’s Lytenava for Wet AMD, Citing Lack of Efficacy Evidence
US FDA Again Rejects Outlook’s Lytenava for Wet AMD, Citing Lack of Efficacy Evidence

Outlook Therapeutics reported Aug. 28 that the US FDA had issued a complete response letter rejecting the company’s resubmitted biologics license application (BLA) for Lytenava, an ophthalmic formu...

Select US FDA Approvals and Clearances in August 2025
Select US FDA Approvals and Clearances in August 2025

The US FDA’s ophthalmic device division granted clearance to two devices using the 510(k) pathway in August 2025, according to the agency’s database. Forus Health gained clearance for its 3nethra N...

PDUFA Dates for Ophthalmic Drug Candidates, September 2025
PDUFA Dates for Ophthalmic Drug Candidates, September 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.

Sandoz’ Deal with Regeneron Will Bring Enzeevu to Market in US by Q4-2026
Sandoz’ Deal with Regeneron Will Bring Enzeevu to Market in US by Q4-2026

Swiss drugmaker Sandoz announced Sept. 9 that it had reached an agreement with Regeneron to resolve all patent disputes related to Sandoz’ FDA-approved Eylea (aflibercept) biosimilar, branded in th...

Researchers See Early Promise in Electromechanical Reshaping of Cornea
Researchers See Early Promise in Electromechanical Reshaping of Cornea

Researchers in California are exploring the possibility of electromechanical reshaping of the cornea for laser-free refractive surgery. Michael Hill, a professor of chemistry at Occidental College,...

STAAR’s Largest Shareholder to Vote Against Alcon Acquisition
STAAR’s Largest Shareholder to Vote Against Alcon Acquisition

New York-based Broadwood Partners, STAAR Surgical’s largest shareholder, filed a preliminary proxy statement with the SEC on Sept. 15, urging fellow shareholders to reject Alcon’s acquisition of ST...

Clinical Trial Updates for Ophthalmic Candidates, September 2025
Clinical Trial Updates for Ophthalmic Candidates, September 2025

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

FDA Looks to End Advisory Panel Meetings
FDA Looks to End Advisory Panel Meetings

US FDA leaders may end advisory panel meetings that weigh the risks and benefits of drugs, KFF Health News reported Sept. 12. The news outlet quoted George Tidmarsh, MD, PhD, head of the FDA’s Cent...

2025-2027 Ophthalmic Meetings Calendar
2025-2027 Ophthalmic Meetings Calendar

Market Scope regularly updates its list of ophthalmic meetings to keep the information current. Please contact us at matthewdouty@market-scope.com if we do not have your meeting listed. Thank you.

Euretina Presentations Included Surprises on Vitreous Cutters, PBM Treatment
Euretina Presentations Included Surprises on Vitreous Cutters, PBM Treatment

Doctors who attend the annual Euretina congress often hear paper presentations similar to those at the American Society of Retina Specialists meeting, but sessions also provide important difference...

Two European Retina Innovation Meetings, Two Audiences
Two European Retina Innovation Meetings, Two Audiences

Euretina once again scheduled its European Innovation Spotlight to go head-to-head with the Ophthalmology Futures Retina Forum. Both were held Sept. 3 in Paris, France. The two events seem similar ...

Former LumiThera Diagnostic Business Relaunches as OpZira After Alcon Deal
Former LumiThera Diagnostic Business Relaunches as OpZira After Alcon Deal

LumiThera’s former ophthalmic diagnostic business has been spun off and relaunched as OpZira, the new company announced Sept. 3. As part of Alcon’s acquisition of the Valeda Light Delivery System f...

Moran Celebrates Approval of AI Tech to Help Time Injections for Wet AMD
Moran Celebrates Approval of AI Tech to Help Time Injections for Wet AMD

The John A. Moran Eye Center is celebrating European regulatory approval of AI technology that assists ophthalmologists in timing intravitreal injections in wet age-related macular degeneration (AM...

Emerging Companies Pursuing Ophthalmic Indications, September 2025
Emerging Companies Pursuing Ophthalmic Indications, September 2025

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

Weekly Surgeon Poll, September 2025
Weekly Surgeon Poll, September 2025

September 2025 Ophthalmic News Briefs
September 2025 Ophthalmic News Briefs

The UK-based National Institute for Health and Care Excellence (NICE) announced Sept. 11 that it had approved idebenone (marketed as Raxone by Chiesi Pharmaceuticals) for the treatment of Leber her...

STAAR’s Largest Shareholder to Vote Against Alcon Acquisition
STAAR’s Largest Shareholder to Vote Against Alcon Acquisition

New York-based Broadwood Partners, STAAR Surgical’s largest shareholder, filed a preliminary proxy statement with the SEC on Sept. 15, urging fellow shareholders to reject Alcon’s acquisition of ST...

Kwangdong Licenses Ocugen’s RP Gene Therapy Candidate for Korea
Kwangdong Licenses Ocugen’s RP Gene Therapy Candidate for Korea

Ocugen announced Sept. 15 that it had reached a licensing agreement with Kwangdong Pharmaceutical for exclusive Korean rights to OCU400—Ocugen’s modifier gene therapy candidate for retinitis pigmen...

Sandoz’ Deal with Regeneron Will Bring Enzeevu to Market in US No Later than Q4-2026
Sandoz’ Deal with Regeneron Will Bring Enzeevu to Market in US No Later than Q4-2026

Swiss drugmaker Sandoz announced Sept. 9 that it had reached an agreement with Regeneron to resolve all patent disputes related to Sandoz’ FDA-approved Eylea (aflibercept) biosimilar, branded in th...

FDA Drug Official Looks to End Advisory Panel Meetings
FDA Drug Official Looks to End Advisory Panel Meetings

US FDA leaders may end advisory panel meetings that weigh the risks and benefits of drugs, KFF Health News reported Sept. 12. The news outlet quoted George Tidmarsh, MD, PhD, head of the FDA’s Cent...

Moria’s Donor Cornea Storage Medium Xtra4 Gains US FDA 510(k) Clearance
Moria’s Donor Cornea Storage Medium Xtra4 Gains US FDA 510(k) Clearance

France’s Moria Surgical announced Sept. 12 that the US FDA had granted 510(k) clearance to Xtra4, a storage medium designed to preserve human donor corneas for up to 14 days under refrigeration (35...

UK’s NICE Approves First Treatment for Leber Hereditary Optic Neuropathy (LHON)
UK’s NICE Approves First Treatment for Leber Hereditary Optic Neuropathy (LHON)

The UK-based National Institute for Health and Care Excellence (NICE) announced Sept. 11 that it had approved idebenone (marketed as Raxone by Chiesi Pharmaceuticals) for the treatment of Leber her...

Formycon, Klinge License Eylea Biosimilar to Horus for France, Other European Countries
Formycon, Klinge License Eylea Biosimilar to Horus for France, Other European Countries

German companies Formycon and Klinge Biopharma announced Sept. 17 that they had reached a deal with France-based Horus Pharma to license their Eylea (aflibercept) biosimilar for France and other se...

Alteogen Gains EU Approval for Eylea Biosimilar Eyluxvi
Alteogen Gains EU Approval for Eylea Biosimilar Eyluxvi

South Korea’s Alteogen announced Sept. 17 that the European Commission had granted marketing authorization for Eyluxvi (formerly ALT-L9), its biosimilar to Eylea (aflibercept 2 mg). The biosimilar ...

Vivani Sets Date for Spin-off of Cortigent Subsidiary (Formerly Second Sight)
Vivani Sets Date for Spin-off of Cortigent Subsidiary (Formerly Second Sight)

Vivani Medical, of Alameda, California, reported Sept. 17 that it had set the record date for its spin-off of Cortigent, its subsidiary developing brain implant devices. Vivani shareholders holding...

€1 Million Champalimaud Vision Award Goes to Three Prominent Eye Charities
€1 Million Champalimaud Vision Award Goes to Three Prominent Eye Charities

The winners of the 2025 António Champalimaud Vision Award are the Fred Hollows Foundation; Lions Clubs International Foundation (LCIF) with its SightFirst program; and the International Agency for ...

Xpanceo and Intra-Ker Unveil Corneal Implant that Projects Images onto Retina
Xpanceo and Intra-Ker Unveil Corneal Implant that Projects Images onto Retina

Xpanceo, of the United Arab Emirates, and Intra-Ker, of Italy, announced Sept. 3 successful proof of concept of their intracorneal implant, designed to restore vision in patients with corneal blind...

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