Ocuphire Pharma announces end-of-phase2 meeting with FDA for APX3330

Ocuphire Pharma announced the successful outcome of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration, supporting the advancement of oral APX3330 for the treatment of diabetic retinopathy (DR) into Phase 3 studies based on the recently completed Phase 2 ZETA-1 trial. “We are pleased to have FDA agreement on the primary endpoint for Phase 3 pivotal trials of APX3330 which we believe is the most advanced oral therapy currently in development for diabetic retinopathy,” said George Magrath, M.D, MBA., M.S., Chief Executive Officer of Ocuphire. “Results from our Phase 2 ZETA-1 results demonstrate that oral APX3330 has the potential to slow or prevent clinically meaningful progression of diabetic retinopathy, as measured by the percentage of subjects with greater than or equal to 3-step worsening on a binocular diabetic retinopathy severity scale, which will be the Phase 3 primary endpoint. As recommended by the FDA, Ocuphire plans to submit a Special Protocol Assessment to agree on the clinical trial protocol and statistical analysis plan for the Phase 3 trials and will share specifics on the study design parameters and anticipated timing once agreed with the FDA. We are grateful for the FDA’s support and guidance and look forward to continued collaboration as we advance APX3330 into Phase 3 development.”