Ocuphire Appoints Jay Pepose, MD, PhD, as Chief Medical Advisor and Announces Upcoming Presentations at ASCRS 2022 and Eyecelerator

Ocuphire Pharma announced the appointment of Jay Pepose, MD, PhD, as its Chief Medical Advisor. In addition, Dr. Pepose, Dr. Ralph Chu, and Dr. Marguerite McDonald will deliver three presentations on Nyxol at the American Society of Cataract and Refractive Surgery (ASCRS) which will be held in Washington, D.C. from April 22-26, 2022. Ocuphire, represented by founder and CEO Mina Sooch, will also be featured in a spotlight refractive showcase at Eyecelerator@ASCRS 2022 on April 21.

“I am honored to take on the role of Chief Medical Advisor at Ocuphire, as I believe the company is on track to become a leader in the development of innovative treatment options for refractive and retinal diseases that affect a large majority of the aging and diabetic population," Dr. Pepose said in a company news release. "2022 has the potential to be transformative for Ocuphire, with both Nyxol and APX3330 programs expected to deliver important clinical and regulatory milestones. I am very pleased to continue working with the highly talented Ocuphire team in an increased capacity. I look forward to advising the company to advance its two late-stage, small molecule drug candidates to address unmet medical needs of patients and sharing Ocuphire’s clinical data with the medical community.”

Dr. Pepose has served on Ocuphire’s Medical Advisory Board since 2018 and Board of Directors since 2021. A specialist in refractive surgery and corneal and external diseases, he is the founder and Medical Director of the Pepose Vision Institute. He also founded the Midwest Corneal Research Foundation, now the Lifelong Vision Foundation, a non-profit organization focused on supporting research and education efforts in ophthalmology and providing vision treatment to underserved communities. He is a professor of clinical ophthalmology and visual sciences at Washington University School of Medicine in St. Louis and a consultant to the Centers for Disease Control and other large ophthalmic companies.

“We are thrilled to name Dr. Pepose as our Chief Medical Advisor. As a key member of our Medical Advisory Board and Board of Directors, Dr. Pepose has already been instrumental in guiding our late-stage clinical programs and engaging in regulatory interactions across all indications for Nyxol eye drops and oral APX3330," Mina Sooch, MBA, Founder and CEO of Ocuphire Pharma, said in the news release. "We are delighted that he will deepen his engagement with our operational and leadership teams at Ocuphire. Dr. Pepose’s appointment also comes at a strategic time for our company, as we look forward to important clinical and regulatory milestones, including a phase 2 APX3330 readout for diabetic retinopathy in the second half of 2022, the initiation of the presbyopia phase 3 program for both Nyxol and Nyxol with low-dose pilocarpine, and a potential NDA submission for Nyxol in reversal of mydriasis in late 2022.”

“We are excited to share three podium presentations on positive efficacy data with Nyxol from our second phase 3 trial (MIRA-3), integrated safety data from the MIRA-2 and MIRA-3 registration trials, and positive single-agent Nyxol phase 2 data at ASCRS. We are pleased to sponsor the ASCRS Beyond 20/20 educational series, which represents a great opportunity to connect with leading physicians and thought leaders,” added Ms. Sooch.

Eyecelerator is a one-day symposium representing a partnership between the American Academy of Ophthalmology (AAO) and the ASCRS with the goal of connecting entrepreneurs, investors, companies, and physicians to advance ophthalmic innovation.

Dr. Chu will present for the first time pooled safety results from the MIRA registration trials of Nyxol for reversal of pharmacologically-induced mydriasis (RM) completed to date, including results from the recently announced MIRA-3 phase 3 trial. These results demonstrated a favorable safety and tolerability profile, consistent with over 10 completed Nyxol trials.

Dr. Pepose will present efficacy data from pre-specified endpoints in the multicenter, randomized, double-masked, placebo-controlled, VEGA-1 phase 2 trial, which demonstrates that Nyxol as a single agent provided durable and statistically significant improvement in distance-corrected near visual acuity (DCNVA) with a favorable safety profile, particularly the absence of headaches, in 150 presbyopia patients. These results support the advancement to phase 3 trials evaluating the efficacy of Nyxol alone and in combination with low dose pilocarpine for presbyopia.

Dr. McDonald will present efficacy data, including new secondary endpoint results, from the completed MIRA-3 phase 3 trial of Nyxol in RM. As announced recently, results showed that Nyxol had statistically significant improvements in reversing pharmacologically-induced mydriasis compared to placebo at all time points from 60 minutes to 24 hours. MIRA-2 and MIRA-3 represent two well-controlled, confirmatory phase 3 clinical trials evaluating Nyxol in RM to support a planned NDA submission with the FDA in late 2022.