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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…
Ocular Therapeutix Enrolls First Patient in Phase 3 Wet AMD Study
Ocular Therapeutix announced that the first patients have been enrolled in its Phase 3 SOL-R clinical trial. This study aims to assess the repeat dosing of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for treating wet age-related macular degeneration…
Nicox Concludes U.S. Recruitment for Phase 3 NCX 470 Trial
Nicox announced the recruitment and randomization of the final patient in the United States for its Denali Phase 3 trial of NCX 470. This milestone marks a significant step in evaluating the safety and efficacy of NCX 470 for patients…
Trial Results for Susvimo Show Sustained Efficacy in DME and DR
Genentech and Roche released compelling 2-year data from the phase 3 Pagoda and Pavilion studies evaluating Susvimo (ranibizumab injection) 100 mg/mL, marking a significant development in the treatment landscape for diabetic macular edema (DME) and diabetic retinopathy (DR). Reintroduction of…
Okyo Pharma’s Phase 2 Trial for Neuropathic Corneal Pain
Okyo Pharma announced its plan to initiate a phase 2 clinical trial for OK-101 in the treatment of neuropathic corneal pain (NCP), scheduled to begin in the third quarter of 2024. This one-year study follows promising results from preclinical animal…