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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…

Cequa Shows Positive Phase 4 Results for Dry Eye

Sun Pharmaceutical has shared new Phase 4 clinical trial data, showcasing the efficacy of Cequa (cyclosporine ophthalmic solution) 0.09% in treating dry eye disease (DED). The results reveal that Cequa provides sustained improvements in patients whose symptoms were inadequately managed…

Bausch + Lomb Recycles 94M Eye Care Waste Units

Bausch + Lomb has announced a major milestone in its sustainability efforts. Through its exclusive recycling initiatives—ONE by ONE Recycling and Biotrue Eye Care Recycling programs—the company has collected 94,119,275 units of used contact lenses, eye care products, and lens…

MediPrint Announces Positive Results for Glaucoma Lens

MediPrint Ophthalmics has revealed positive findings from its Phase 2b clinical trial for LL-BMT1, a 3D-printed, drug-eluting contact lens designed to treat mild to moderate glaucoma. These results, presented by Ian Ben Gaddie, OD, FAAO, at the American Academy of…

Atsena & Nippon Shinyaku Partner on ATSN-101

Atsena Therapeutics, Inc. and Nippon Shinyaku Co., Ltd. have entered an exclusive licensing agreement to advance and commercialize ATSN-101, an investigational gene therapy for Leber congenital amaurosis type 1 (LCA1), in both the United States and Japan. ATSN-101 is designed…

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