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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
Peptide Eye Drops Offer Hope for Dry AMD
Researchers from the Natural Product Drug Development Center at the Korea Institute of Science and Technology (KIST), led by Dr. Moon-Hyeong Seo, have developed an innovative therapeutic agent for dry age-related macular degeneration (AMD) in the form of peptide-based eye…
Galimedix Begins Phase 2 Trial for GAL-101 in Dry AMD
Galimedix Therapeutics has announced the initiation of a phase 2 clinical study called eDREAM (NCT06659549), evaluating the efficacy and safety of GAL-101 eye drops in patients with dry age-related macular degeneration (AMD) and geographic atrophy (GA). About the Phase 2…
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…
4DMT Reveals Preclinical Data on TVE Platform
4D Molecular Therapeutics (4DMT) has announced the publication of preclinical data underscoring the capabilities of its Therapeutic Vector Evolution (TVE) platform. The research focuses on the intravitreal R100 vector and the R100-based genetic medicine 4D-150. This groundbreaking study, titled “Design…
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…
2023 Recap: Top 15 Research in Ophthalmology
2024 Recap is here! Click to review:Top 10 Breakthroughs in Ophthalmology Research In the fast-evolving landscape of ophthalmology research, 2023 has proven to be a pivotal year marked by groundbreaking discoveries and innovation. From revolutionary cell replacement therapies to novel…