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UK MHRA approves phase 2a study for ANXV for diabetic retinopathy
(Image credit: AdobeStock/Janis Smits) UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the start of a clinical Proof of Concept phase 2a study with the drug candidate ANXV in the eye disease diabetic retinopathy (DR). Patients with newly…
FDA clears IND for Opus Genetics’ OPGx-BEST1 gene therapy for inherited retinal disease
(Image Credit: AdobeStock/Corona Borealis) The US Food and Drug Administration (FDA) has accepted Opus Genetics’ Investigational New Drug (IND) application for OPGx-BEST1, a gene therapy for the treatment of bestrophin-1 (BEST1)-related inherited retinal disease (IRD). Best disease, or vitelliform macular…
Study establishes reference data set for geographic atrophy lesion progression
(Image Credit: AdobeStock/tadamichi) The lesion characteristics of patients with geographic atrophy (GA) were found to affect the lesion growth rate, with fovea-sparing, multifocal, and bilateral lesions having the fastest growth rates in a study published in Translational Vision Science &…
RemeGen and Santen Enter into Exclusive Licensing Agreement for Ophthalmic Innovative Drug RC28-E in Greater China and Asian countries – PR Newswire
RemeGen and Santen Enter into Exclusive Licensing Agreement for Ophthalmic Innovative Drug RC28-E in Greater China and Asian countries PR Newswire Source: Author: | Date: 2025-08-18 07:00:00 Source: Author: | Date: 2025-08-18 07:00:00
FDA Green Lights Amneal's $201M Generic Eye Drug: Q3 2025 Launch Set for Pred Forte Alternative – Stock Titan
FDA Green Lights Amneal’s $201M Generic Eye Drug: Q3 2025 Launch Set for Pred Forte Alternative Stock Titan Source: Author: | Date: 2025-06-12 07:00:00 Source: Author: | Date: 2025-06-12 07:00:00
Glaukos Submits FDA Application for Epioxa Therapy
Glaukos Corporation has officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its innovative corneal cross-linking therapy, Epioxa (Epi-on). This next-generation treatment is designed for patients with keratoconus and represents a significant advancement…
Opus Gets FDA SPA for APX3330 Phase 3 Trial
Opus Genetics has announced a key regulatory milestone, securing a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of APX3330. The oral treatment is being evaluated for moderate to…
EYLEA HD Succeeds in Phase 3 RVO Trial
Regeneron Pharmaceuticals has announced that its Phase 3 QUASAR trial evaluating EYLEA HD (aflibercept 8 mg) has met its primary endpoint, marking a significant advancement in the treatment of retinal vein occlusion (RVO). About the QUASAR Trial The QUASAR trial…
Aurion’s AURN001 Shows Positive Phase 1/2 Results
Aurion Biotech has released topline data from its Phase 1/2 clinical trial (CLARA), evaluating AURN001, an allogeneic cell therapy product candidate for treating corneal edema secondary to corneal endothelial dysfunction. These results highlight the therapy’s potential as a groundbreaking treatment…
FDA Clears ViGeneron’s VG801 for Stargardt Disease
The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for VG801, ViGeneron’s novel gene therapy candidate designed to treat Stargardt disease and other retinal dystrophies caused by mutations in the ABCA4 gene. This marks…