Ocuphire Pharma schedules End-of-Phase 2 meeting with FDA for APX3330

Ocuphire Pharma announced that results from the ZETA-1 Phase 2 trial evaluating APX3330 in diabetic retinopathy will be presented at the American Society of Retinal Specialists annual scientific meeting to take place in Seattle, Washington, July 28 to August 1. In addition, Ronil Patel, MTech, MS, SVP of Operations & Business Development at Ocuphire, will provide a corporate update at the OIS Retina Innovation Summit on July 27, also in Seattle, Washington. Ocuphire also announced that it has scheduled an End-of-Phase 2 meeting with the FDA in Q4 2023 to discuss the specifics of the APX3330 development program. In the ZETA-1 trial, APX3330 achieved statistical significance in preventing clinically meaningful progression of diabetic retinopathy, as measured by the percentage of subjects with binocular greater than or equal to3-step worsening in DRSS, the anticipated Phase 3 primary endpoint. “APX3330 is the most advanced oral program currently in development for diabetic retinopathy, and the End-of-Phase 2 meeting confirmed for Q4 2023 is a critical milestone for our development program,” said Rick Rodgers, Interim CEO of Ocuphire. “Currently, patients with non-proliferative diabetic retinopathy are not treated due to the lack of non-invasive options on the market and the monthly time burden required for intravitreal injections. Eighty percent of physicians prefer to use a wait-and-see approach for these patients rather than delivering a monthly biologic treatment where patients often become incomplete responders. If approved, APX3330 has the potential to shift the treatment paradigm and be the first non-invasive, oral, early treatment for the 8 million NPDR patients who are at risk of progressing to vision-threatening complications. We look forward to working with the FDA to confirm the Phase 3 study design and advancing APX3330 towards a potential NDA submission.”