Ocuphire Initiates ZETA-1 Phase 2 Clinical Trial Investigating APX3330 in Diabetic Retinopathy

APX3330 has the Potential to be a Novel Oral Treatment Option with Dual Mechanism of Anti-VEGF and Anti-Inflammatory for Diabetic Retinopathy

Top Line Data from ZETA-1 Expected by Early 2022

FARMINGTON HILLS, Mich., April 08, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, announced today that it has screened the first patient in ZETA-1, a Phase 2 trial to evaluate APX3330 in non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (mild PDR). Effects on diabetic macular edema will be explored as a secondary outcome. A number of retinal centers across the US are active and recruiting eligible diabetic retinopathy patients.

Diabetes is the leading cause of blindness among adults aged 20 – 74. In the United States alone, over 7 million patients suffer from diabetic retinopathy (DR), a complication of diabetes in which chronically elevated blood sugar levels cause damage to blood vessels in the retina. An additional 750,000 patients suffer from diabetic macular edema (DME), one of the most common complications of diabetic retinopathy where the macula swells from fluid leaked from damaged blood vessels. The disease progression of both DR and DME involves abnormal vessel proliferation and inflammation. Thus, current approved treatments for DR and DME encompass an over $10 billion global market and involve administering anti-VEGF injections (such as EYLEA by Regeneron, Lucentis by Genentech, and Avastin by Genentech) to decrease vessel formation or steroids (such as OZURDEX by Allergan) to decrease inflammation into eyes with advanced retinal disease. ZETA-1 is investigating the potential of APX3330 to offer an innovative and conveniently administered oral treatment for diabetic retinopathy that addresses both of these disease pathways.

Dr. Peter K. Kaiser, Professor of Ophthalmology at the Cole Eye Institute of the Cleveland Clinic Foundation commented, “There remains a strong need to develop a non-injectable alternative treatment option for patients with DR as these injectables—although approved for this indication— are not widely used. If successfully developed, APX3330 could lead to the first oral option for DR as well as an adjunct therapy that may improve dosing convenience and compliance by alleviating some of the burden of chronic anti-VEGF injection treatments for DME and other retinal diseases.”