Ocuphire Pharma announces presentation on APX3330

Ocuphire Pharma announced that clinical data from its ZETA-1 trial on a person-level scale evaluating APX3330 in diabetic retinopathy were presented at the 21st Annual Angiogenesis, Exudation, and Degeneration 2024 Conference, which took place virtually on Saturday, February 3, 2024. The presentation was titled APX3330 Oral Treatment to Slow the Progression of Diabetic Retinopathy Using a Binocular DRSS Severity Scale as a Registrational Endpoint. Presentation Highlights: ZETA-1 was a Phase 2 trial of oral APX3330 in DR. It was a multi-center, randomized, double-masked, placebo-controlled trial that enrolled 103 subjects. Topline results were announced by Ocuphire in January 2023. In November, a successful end-of-phase 2 meeting outcome was announced with an agreement on Phase 3 primary endpoint of 3-step worsening on a binocular 17-step person-level scale using the Diabetic Retinopathy Severity Scale. Analysis of ZETA-1 Phase 2 results using the person-level scale, showed only 5% of subjects treated with APX3330 had a clinically meaningful greater than or equal to 3-step worsening in DRSS at Week 24 on this binocular person-level scale, compared with 13% of placebo patients. APX3330 showed favorable safety and tolerability in diabetic patients that continued dosing their medications through the study durations to manage their diabetic comorbidities.