The company announced it has scheduled an End-of-Phase 2 meeting with the FDA in Q4 2023 to discuss the specifics of the APX3330 development program.
Ocuphire Pharma Inc. announced that results from the ZETA-1 Phase 2 trial evaluating APX3330 in diabetic retinopathy will be presented this week at the American Society of Retina Specialists (ASRS) annual scientific meeting being held Friday through Tuesday in Seattle, Washington.
In addition, Ronil Patel, MTech, MS, senior vice president of Operations and Business Development at Ocuphire, will provide a corporate update at the OIS Retina Innovation Summit Thursday in Seattle, Washington.
Ocuphire announced in a news release it has scheduled an End-of-Phase 2 meeting with the FDA in Q4 2023 to discuss the specifics of the APX3330 development program.
According to the company, In the ZETA-1 trial, APX3330 achieved statistical significance in preventing clinically meaningful progression of diabetic retinopathy (DR), as measured by the percentage of subjects with binocular ≥3-step worsening in DRSS, the anticipated Phase 3 primary endpoint.
Rick Rodgers, interim CEO of Ocuphire, said in the news release 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 the company’s development program.
“Currently, patients with non-proliferative diabetic retinopathy (NPDR) are not treated due to the lack of non-invasive options on the market and the monthly time burden required for intravitreal injections,” he said in a statement. “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. “
Rodgers added that if it is improved, APX3330 could 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,” Rodgers concluded in the release.
At the meeting, David Lally MD, will present ZETA-1 Phase 2 Trial Efficacy Results for APX3330: a Novel, Oral Ref-1 Inhibitor for the Treatment of Diabetic Retinopathy at 9:35 am PT Tuesday.
Daniel Su, MD, will present ZETA-1 Phase 2 Trial Safety and Tolerability Results for APX3330: a New Oral Ref-1 Inhibitor for the Treatment of Diabetic Retinopathy at 9:41 am PT Tuesday.
On Thursday, Patel will present his corporate update during the Innovation Showcase from 8:35 am to 10 am PT at the Hyatt Regency Seattle.