According to the company, the launch of the presbyopia phase 3 program is supported by positive clinical results that demonstrated durable efficacy and a favorable safety profile.
Ocuphire Pharma Inc. today announced the initiation of the VEGA-2 phase 3 pivotal trial with the first patient enrolled in late December.
VEGA-2 (NCT05546719) is evaluating the efficacy and safety for two labels: Phentolamine ophthalmic solution 0.75% (Nyxol) alone and phentolamine ophthalmic solution 0.75% with adjunctive low-dose pilocarpine (LDP) therapy for presbyopia.
Mina Sooch, MBA, founder and CEO of Ocuphire, pointed out in a news release that 2023 promises to be a pivotal year for executing the company’s comprehensive Phase 3 program in presbyopia.
“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), for the development and commercialization of Nyxol across three indications.”
Moreover, Jay Pepose, MD, PhD, chief medical advisor of Ocuphire, noted that in the company’s previous Phase 2 VEGA-1 trial, phentolamine ophthalmic solution 0.75% 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.
“Physicians are enthusiastic about the potential for a safe, effective, convenient and durable pharmacologic option for their presbyopia patients,” he said in the news release.
VEGA-2 Phase 3 Pivotal Trial Design
According to the company, VEGA-2 is a randomly assigned, double-masked, placebo-controlled, multi-center, Phase 3 study to evaluate phentolamine ophthalmic solution 0.75% as a single agent and with adjunctive low-dose pilocarpine (LDP) 0.4% in 320 subjects with presbyopia. The study will be conducted in 2 stages.
Stage 1 has two treatment groups (Nyxol or placebo), with approximately 160 subjects in each group. Stage 2 will have four treatment groups (Nyxol + LDP, Nyxol + LDP vehicle, placebo + LDP, and placebo + LDP vehicle), with approximately 80 subjects per treatment group. Subjects will be recruited from upto 30 investigational sites in the US.
In addition to VEGA-2 trial, Ocuphire plans to initiate a second Phase 3 pivotal trial in presbyopia (VEGA-3), and a one-year safety study (LYRA-1) in 2023.