The first patient has been enrolled in a phase 3 trial pivotal trial, evaluating the safety and efficiency of a new eye drop treatment for presbyopia.
The VEGA-2 Phase 3 trial is investigating Nylox (phentolamine ophthalmic solution 75%) as a single agent and Nyxol with adjunctive low-dose pilocarpine (LDP) therapy for presbyopia.
The VEGA-2 Phase 3 trial is investigating Nylox… as a single agent and Nyxol with adjunctive low-dose pilocarpine (LDP) therapy for presbyopia
Ocuphire Pharma announced the start of the trial last week with the enrolment of the first patient in December last year. Ocuphire is an ophthalmic biopharmaceutical company focussed on developing and commercialising small-molecule therapies for the treatment of refractive and retinal eye disorders.
In a news release on the Ocuphire website, the company’s Chief Medical Advisor, Dr Jay Pepose, said in the previous Phase 2 VEGA-1 trial, Nyxol alone demonstrated “compelling results with rapid onset and sustained 18-hour duration of efficacy and a favourable safety profile.
“The LDP combination option also offers the potential for tunability of treatment based on the patient’s lifestyle and response to Nyxol alone,” Dr Pepose said.
VEGA-2 is a randomised, double-masked, placebo-controlled, multi-centre study being conducted in the United States.
The study will be conducted in two 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.
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.
