Opus Genetics

Opus Genetics reached an FDA SPA agreement for a Phase 3 trial of oral APX3330 to treat moderate to severe NPDR, with a primary endpoint of reducing DRSS score worsening. APX3330, a small-molecule inhibitor, showed potential in Phase 2 trials and aims to be a transformative treatment for NPDR, a leading cause of blindness in adults with diabetes.

US FDA accepts NDA for LENZ Therapeutics' LNZ100 for presbyopia treatment, supported by Phase 3 CLARITY study data. Ocuphire Pharma acquires Opus Genetics, forming a key player in gene therapy for inherited retinal diseases. A study suggests 19% of dementia prevalence may result from correctable visual impairments. An optometrist shares experience in retina subspecialty. A new study finds higher glaucoma prevalence in the US than previously estimated.

Ocuphire Pharma acquired Opus Genetics in an all-stock deal, renaming the combined entity Opus Genetics, Inc., set to trade on Nasdaq as 'IRD'. The merger expanded the pipeline with AAV-based gene therapies for inherited retinal diseases and phentolamine ophthalmic solution. Leadership remains with George Magrath, MD as CEO, and Ben Yerxa, PhD as President. The company plans to seek a strategic partner for APX3330, an oral small-molecule inhibitor for diabetic retinopathy, while focusing on gene therapy initiatives like OPGx-LCA5 for LCA5, with early data showing visual improvements. The combined company expects clinical milestones in 2025 and extended its cash runway into 2026.