Ocuphire Pharma, Inc. announced that a late-breaking poster and ePoster theater presentation titled Oral APX3330 Reduces the DRSS Worsening after 24-we weeks of Daily Treatment--Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy was presented by retina specialist and ZETA-1 clinical trial investigator, Victor H. Gonzalez, M.D. at the 83(rd) Scientific Sessions of the American Diabetes Association (ADA) in San Diego, CA on June 24, 2023. In this 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, company anticipated Phase 3 primary endpoint. Compared to the current intravitreal injection options, a non-invasive convenient oral therapy that prevents disease progression could shift the treatment paradigm and broaden the prescriber base to include not only eye care physicians but primary care and endocrinologists.

The ADA meeting is an excellent forum to share the ZETA-1 data on APX3330. APX3330 demonstrated statistically significant reduction of disease progression at 24 weeks: no (0%) APX3330-treated patients had a binocular = 3-step worsening of DRSS from baseline compared with 16% for placebo-treated patients (p=0.04). This endpoint is the planned Phase 3 primary endpoint for future registration trials that will be confirmed at the EOP2 meeting with the FDA.