Ophthalmology Breaking News: Weekly Roundup (Sep 2, 2025)

Nicox’s NCX 470 Achieves Phase 3 Success, Clears Path for NDA in U.S. and China

📢 Nicox has reported positive topline results from the Denali Phase 3 trial of NCX 470 0.1%, meeting its primary endpoint and supporting upcoming NDA filings.

In a randomized, multicenter trial involving 696 patients with open-angle glaucoma or ocular hypertension, NCX 470 0.1% once daily showed noninferiority to latanoprost 0.005% in intraocular pressure (IOP) reduction. Mean IOP reductions for NCX 470 ranged from 7.9 to 10.0 mmHg compared to 7.1 to 9.8 mmHg for latanoprost at time-matched points across weeks 2, 6, and month 3. While superiority was not achieved, NCX 470 demonstrated statistically significant advantages at 3 of 6 timepoints.

These findings align with the earlier Mont Blanc Phase 3 trial, confirming efficacy and a consistent safety profile.

Dr. Don Budenz, Coordinating Investigator said;

“The Denali trial results validate the robust therapeutic profile of NCX 470 observed in the Mont Blanc trial”

🔗 Learn how Nicox’s dual-action eye drop could reshape IOP management in major markets.

European Commission Approves Mynzepli, Aflibercept Biosimilar for Retinal Diseases

📢 The European Commission has granted marketing authorization to Mynzepli (AVT06), a biosimilar to aflibercept, expanding treatment options for serious retinal diseases across the EU.

Mynzepli, developed by Alvotech and Advanz Pharma, is now approved for use in all EU member states, Iceland, Liechtenstein, and Norway. The biosimilar, available in a 40 mg/mL pre-filled syringe and vial, is indicated for conditions including neovascular AMD, diabetic macular edema, retinal vein occlusion, and myopic choroidal neovascularization—mirroring the approved uses of Eylea.

Regulatory approval follows successful comparative trials showing equivalent efficacy and safety to aflibercept. The EMA’s Committee for Medicinal Products for Human Use (CHMP) previously issued a positive opinion prior to EC approval.

Joseph McClellan, Chief Scientific and Technical Officer at Alvotech said;

“Timely access to effective therapies is essential for individuals affected by retinal diseases”

“The approval of Mynzepli represents important progress in providing innovative and affordable treatment options.”

🔗 Understand the implications of biosimilar expansion in ophthalmology care across the EU.

FDA Issues Second Complete Response Letter for Outlook Therapeutics’ Bevacizumab-Vikg

📢 Outlook Therapeutics has received a second Complete Response Letter (CRL) from the FDA for its wet AMD candidate ONS-5010 (bevacizumab-vikg), citing insufficient evidence of efficacy.

The CRL noted that the NORSE EIGHT study failed to meet its primary endpoint, and the FDA requires additional confirmatory evidence before approving the first on-label bevacizumab formulation for intravitreal use in the U.S. While the NORSE TWO trial had shown positive results, it was not enough to support the Biologics License Application.

Bob Jahr, CEO of Outlook Therapeutics said;

“There were no other outstanding deficiencies noted in the CRL”

“We intend to meet with the FDA to receive additional clarity on their requirements.”

This setback follows a prior CRL in 2023, which had cited manufacturing and inspection issues. Despite U.S. regulatory hurdles, the product -marketed as Lytenava- has been approved and launched in Europe and the UK.

🔗 Track the evolving landscape of anti-VEGF therapies and where ONS-5010 stands in global markets

GLP-1 Receptor Agonists Linked to Slight DR Risk, But Lower Severe Eye Complications

📢 A new study published in JAMA Network Open links GLP-1 receptor agonists (GLP-1 RAs) to a modest increase in diabetic retinopathy (DR) incidence, but a decreased risk of severe complications.

Led by Dr. David J. Ramsey of UMass Chan-Lahey School of Medicine, this retrospective cohort study assessed over 185,000 patients with type 2 diabetes. GLP-1 RA use was associated with a slight increase in incident DR (hazard ratio: 1.07), but no increased risk for NAION.

Crucially, among a subgroup of 32,695 patients with preexisting DR, GLP-1 RAs were linked to reduced risks of proliferative DR, diabetic macular edema, vitreous hemorrhages (HR: 0.74), neovascular glaucoma (HR: 0.78), and blindness (HR: 0.77).

The study authors noted;

“GLP-1 RAs may be a factor in reduced rates of vision loss leading to blindness,”

They emphasize the importance of regular ophthalmic monitoring for patients receiving GLP-1 RA therapy.

🔗 Review the complex impact of GLP-1 therapies on diabetic retinopathy and patient management strategies.

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