Ocuphire Announces APX3330 Phase 2 Data Presentations at Retina Meetings

Ocuphire Pharma announced two presentations featuring efficacy and safety results from the company’s recently completed ZETA-1 phase 2 trial of oral APX3330 in diabetic retinopathy (DR) at two medical meetings in February.

Peter Kaiser, MD, Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine and Cole Eye Institute, presented the results at the Angiogenesis, Exudation, and Degeneration 2023 Meeting held virtually on February 10-11, 2023. Rishi P. Singh, MD, President of Cleveland Clinic Martin North and South hospitals, and Professor of Ophthalmology at the Lerner College of Medicine, will present at the upcoming Macula Society 46th Annual Meeting, to be held in-person February 15-18, 2023 in Miami.

Dr. Kaiser’s presentation, titled, “Efficacy and Safety Data for APX3330, a Novel Oral Drug Candidate for DR/DME, from the ZETA-1 Phase 2 Trial,” discussed results from the trial during the "Diabetic Retinopathy Imaging and Treatment" session at the 20th Angiogenesis, Exudation, and Degeneration 2023 Meeting. Oral APX3330 achieved statistical significance on a key prespecified secondary DRSS (diabetic retinopathy severity scale) endpoint of preventing clinically meaningful progression of DR after 24 weeks of treatment. In addition, APX3330 demonstrated a favorable systemic and ocular safety and tolerability profile.

“The phase 2 clinical trial results of the oral drug candidate APX3330 that were presented at the Angiogenesis 2023 meeting showed favorable efficacy, safety, and tolerability. Intravitreal injections are currently approved for DR based on 2-step improvement in DRSS in one eye. What was new for many retina specialists is that for a systemic medication that works in both eyes, the use of binocular improvement or prevention of worsening in DRSS is an acceptable endpoint for FDA approval. We would prefer to treat our DR patients early and non-invasively, so an oral treatment option that prevents worsening of DR would be very appealing," Dr. Kaiser said.

Presentation details for the Macula Society 46th Annual Meeting presentation can be found below: