APX-3330
- Generic Name
- APX-3330
FDA Grants Fast Track Status to Opus Genetics' Eye Drop Treatment for Night Vision Impairment
• Opus Genetics receives FDA Fast Track designation for Phentolamine Ophthalmic Solution 0.75% to treat night driving impairment in post-keratorefractive surgery patients.
• The company completes enrollment in VEGA-3 Phase 3 trial evaluating the same solution for presbyopia, with 545 participants across 39 U.S. sites.
• LYNX-2 Phase 3 trial for post-surgical night vision impairment is 95% enrolled, with completion expected in first half of 2025.
Opus Genetics Advances LCA5 Gene Therapy Program with First Pediatric Patient Dosing and Promising Adult Data
• Opus Genetics has dosed the first pediatric patient in their Phase 1/2 trial of OPGx-LCA5 gene therapy for Leber congenital amaurosis, with initial data expected by Q3 2025.
• New 12-month data from the first three adult patients treated with OPGx-LCA5 confirms durability of positive responses observed at 6 months, with results to be presented at a medical conference in Q2 2025.
• The company has scheduled an FDA meeting in March 2025 to discuss Phase 3 trial design and registrational endpoints, marking a significant step toward potential therapeutic advancement.
Global Diabetic Retinopathy Clinical Trials Landscape Analysis Reveals Key Research Trends for 2024
• A comprehensive analysis of global diabetic retinopathy clinical trials has been released, offering insights into trial distribution across G7 and E7 countries and various research phases.
• The report highlights significant trends in trial enrollment patterns over the past five years, providing valuable data for healthcare stakeholders and pharmaceutical companies.
• The analysis covers detailed assessment of trial statuses, sponsor types, and endpoint evaluations, helping identify key opportunities and challenges in diabetic retinopathy research.
Opus Genetics Gains FDA Agreement for Phase 3 Trial of APX3330 in Diabetic Retinopathy
• Opus Genetics has reached an agreement with the FDA under a Special Protocol Assessment (SPA) for a Phase 3 trial of oral APX3330.
• The Phase 3 trial will assess APX3330's efficacy in treating moderate to severe non-proliferative diabetic retinopathy (NPDR).
• The primary endpoint is a reduction in 3-step or greater worsening on the binocular diabetic retinopathy severity scale (DRSS) score.
• APX3330, a first-in-class Ref-1 inhibitor, aims to slow DR progression, with Opus seeking a partner to fund further development.
Ocuphire Pharma Acquires Opus Genetics, Expanding Gene Therapy Pipeline for Inherited Retinal Diseases
• Ocuphire Pharma has acquired Opus Genetics in an all-stock transaction, with the combined company renamed Opus Genetics, Inc., focusing on inherited retinal diseases.
• The acquisition expands the pipeline to include AAV-based gene therapies for IRDs and phentolamine ophthalmic solution for presbyopia, while seeking a partner for diabetic retinopathy program.
• OPGx-LCA5, a gene therapy for LCA5, shows promising early Phase 1/2 data with visual improvements in patients, and pediatric enrollment is expected in early 2025.
• The merger extends the company's cash runway into 2026, anticipating key clinical milestones, including data readouts from multiple Phase 1/2 and Phase 3 trials.
Drug Development Updates
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