First patient enrolled in Ocuphire Phase 3 pivotal trial of Nyxol for presbyopia

Ocuphire Pharma announced today that in later December 2022 the first patient enrolled in the VEGA-2 Phase 3 trial for phentolamine ophthalmic solution 0.75% (Nyxol) for presbyopia. VEGA-2 is investigating both Nyxol as a single agent and Nyxol with adjunctive low-dose pilocarpine (LDP) therapy for presbyopia.

“2023 promises to be a pivotal year for executing our comprehensive Phase 3 program in presbyopia,” Mina Sooch, MBA, founder and CEO of Ocuphire, said in a statement. “We also recently achieved a major milestone with the submission of the NDA for the first Nyxol indication in reversal of mydriasis (RM). We are excited to add these important accomplishments to our recently closed global license agreement with FamyGen Life Sciences (recently acquired by Viatris [Nasdaq: VTRS]), for the development and commercialization of Nyxol across three indications.”

VEGA-2 is a randomized, double-masked, placebo-controlled, multi-center Phase 3 study. The dual-stage study will evaluate 320 patients with presbyopia. Stage 1 will evaluate 2 groups, treated with either Nyxol or placebo, with approximately 160 subjects per group. Stage 2 will examine 4 groups of approximately 80 patients each. The 4 groups will receive one of the following treatments: Nyxol + LDP, Nyxol + LDP vehicle, placebo + LDP, and placebo + LDP vehicle. Subjects will be recruited from up to 30 investigational sites across the United States.

“In our previous Phase 2 VEGA-1 trial, Nyxol alone demonstrated compelling results with rapid onset and sustained 18-hour duration of efficacy and a favorable safety profile; then the LDP combination option also offers the potential for tunability of treatment based on the patient’s lifestyle and response to Nyxol alone,” stated Jay Pepose, MD, PhD, Chief Medical Advisor of Ocuphire. “Physicians are enthusiastic about the potential for a safe, effective, convenient and durable pharmacologic option for their presbyopia patients.”

Following VEGA-2, Ocuphire intends to initiate a second Phase 3 pivotal trial in presbyopia (VEGA-3) and a one-year safety study (LYRA-1) later this year.