Ocuphire Pharma Announces Presentation on APX3330 at the ARVO 2024 Annual Meeting

FARMINGTON HILLS, Mich., May 06, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP) (“Ocuphire”), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of retinal and refractive eye disorders, today announced that clinical data from its ZETA-1 trial evaluating APX3330 in diabetic retinopathy (DR) on a validated binocular person-level scale was presented yesterday at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, taking place May 5-9, 2024 in Seattle, Washington. The presentation, titled Oral APX3330, a Ref-1 Inhibitor, Slows Progression of Diabetic Retinopathy on a Binocular DRSS Person-Level Scale, was delivered by Daniel Su, M.D., a practicing retina specialist at Retina-Vitreous Associates Medical Group (LA Retina) in Los Angeles, California.

Presentation Highlights:

• ZETA-1 was a Phase 2, randomized, double-masked trial evaluating the efficacy and safety of oral APX3330 compared to placebo in 103 participants with DR completed in January 2023.
• A subset analysis was conducted to evaluate the efficacy of APX3330 in slowing DR progression using the target population of the planned Phase 2/3 study and the Food and Drug Administration’s (the FDA)-agreed upon registration endpoint of a 3-step change on a binocular diabetic Retinopathy Severity Scale (DRSS). This 17-step person-level scale accounts for the DRSS scores of the two eyes and then anchors the step to the worse eye. The subset comprised 68 participants from the ZETA-1 trial who had a baseline DRSS score of 47 or 53 in at least one eye and 43, 47 or 53 in the other eye.
• Analysis of the ZETA-1 Phase 2 subset using the binocular person-level scale showed that no participants in the APX3330 group had a ≥ 4-step worsening at week 24 compared to 15.2% in the placebo group, representing a 100% reduction between groups (p=0.07). Similarly, only 5.7% of APX3330-treated subjects had a ≥ 3-step worsening at week 24 compared to 15.2% of placebo subjects, representing a 62.5% reduction between groups (p=0.26).
• Fewer participants in the APX3330 group developed proliferative diabetic retinopathy (PDR) by week 24 compared to the placebo group (11% vs 26% respectively; p=0.13).
• APX3330 showed favorable safety and tolerability, with similar ocular adverse events between APX3330 and placebo groups.