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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…
EC Approves Opuviz, Eylea Biosimilar
Samsung Bioepis and Biogen have announced that the European Commission (EC) has approved Opuviz 40 mg/mL for injection. This biosimilar, also known as SB15, references the widely used treatment Eylea (aflibercept). The approval encompasses a range of retinal conditions, providing…
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…
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…
Formosa: Positive Phase 3 Results for APP13007 in China
Formosa Pharmaceuticals recently announced the completion of CPN-303, a Phase 3 clinical trial conducted in Chinese cataract surgery patients to evaluate APP13007 (GPN00833). This trial, managed by Formosa’s licensee Grand Pharma (0512.HK), demonstrated positive top-line results, showcasing APP13007’s effectiveness in…
GenSight: Lumevoq Most Effective for ND4-LHON
GenSight Biologics recently published a meta-analysis focused on assessing the efficacy of various treatments for Leber Hereditary Optic Neuropathy (LHON) due to the MT-ND4 mitochondrial gene mutation, known as ND4-LHON. The study, which appears in Survey of Ophthalmology, represents a…
FDA Fast Tracks FLQ-101 for Retinopathy of Prematurity
The U.S. FDA has granted fast track designation to FLQ-101, FELIQS’ oral and intravenous solution targeting retinopathy of prematurity (ROP). This designation will accelerate the regulatory review process for FLQ-101, a promising treatment for a condition currently lacking approved preventative…