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ONS-5010 Falls Short in NORSE EIGHT Trial for Wet AMD
ONS-5010 (LYTENAVA), an ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (AMD), failed to meet the noninferiority endpoint in the NORSE EIGHT clinical trial, according to preliminary topline results announced by Outlook Therapeutics. About the NORSE EIGHT Trial…
Avirmax Launches ABI-110 Gene Therapy Trial for Wet AMD
Avirmax Biopharma has reached a major milestone in its mission to revolutionize the treatment of wet age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV) by successfully dosing the first patient in the phase I/IIa clinical trial of ABI-110, the…
CHMP Endorses FYB203: Aflibercept Biosimilar Approval
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to aflibercept. This development marks a significant milestone in expanding affordable…
USC Receives $6M Grant for Dry AMD Therapy
The California Institute for Regenerative Medicine (CIRM) has awarded a $6 million, two-year grant to researchers at the USC Dr. Allen and Charlotte Ginsburg Institute for Biomedical Therapeutics and the USC Roski Eye Institute. This funding will advance preclinical studies…
Positive Phase 3 Results for MELT-300 Sedation
Melt Pharmaceuticals has reported promising topline results from the pivotal Phase 3 trial of MELT-300, a novel, non-intravenous, non-opioid sedation tablet developed for use during cataract surgeries. The study, conducted under an FDA-approved Special Protocol Assessment (SPA) agreement, demonstrated that…
Ocugen Shares Positive OCU410 Trial Results for GA
Ocugen has released encouraging preliminary findings from the Phase 1 portion of its Phase 1/2 OCU410 ArMaDa clinical trial, focused on treating geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The results demonstrate the potential of OCU410 as…
FDA Awards Designations to Gildeuretinol for Stargardt
Key Takeaways • Gildeuretinol (ALK-001) has received Rare Pediatric Disease and Fast Track designations, alongside prior Breakthrough Therapy and Orphan Drug statuses, emphasizing its potential to transform treatment for Stargardt disease. • Data from the TEASE-1…
FDA Reviews Aldeyra’s Dry Eye Drug
Aldeyra Therapeutics has announced a major milestone as the FDA formally accepted its resubmitted New Drug Application (NDA) for reproxalap, a topical ocular therapy for the treatment of dry eye disease. Alongside this regulatory progress, Aldeyra has expanded its exclusive…
Alcon’s IOL Faces Probe by CDSCO
The Central Drugs Standard Control Organisation (CDSCO) has formed a committee to investigate allegations of quality issues with an intraocular lens (IOL) supplied by Alcon. The Swiss-American company specializes in eye care products, including lenses for cataract surgery. Specifics of…
Eyenovia Pediatric Myopia Trial Falls Short
Eyenovia has announced that its Phase 3 CHAPERONE study, aimed at treating pediatric progressive myopia, failed to meet its primary endpoint. The trial evaluated the company’s proprietary drug-device combination using low-dose atropine delivered via the Optejet platform. A review by…