Ocuphire Pharma, Inc. announced the initiation of the VEGA-2 Phase 3 pivotal trial with the first patient enrolled in late December. VEGA-2 is evaluating the efficacy and safety for two labels: Nyxol® alone and Nyxol with adjunctive low-dose pilocarpine (LDP) therapy for presbyopia. VEGA-2 is a randomized, double-masked, placebo-controlled, multi-center, Phase 3 study to evaluate Nyxol (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. For more information on the trial design and endpoints, please refer to www.ClinicalTrials.gov Identifier NCT05646719. 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.