Ocuphire Pharma, Inc. announced that the first patient has been enrolled in the VEGA-2 phase 3 pivotal trial evaluating Nyxol for presbyopia.
Tell me more about Nyxol
Nyxol is a preservative-free ophthalmic solution of 0.75% phentolamine mesylate to be administered once a day at night to reduce pupil dilation across three indications: dim light/night vision disturbances, reversal of mydriasis (Nyxol as standalone), and with presbyopia (Nyxol with adjunctive pilocarpine 0.4%). (via)
Ocuphire was granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) by the FDA for the 505(b)(2) New Drug Application (NDA) for Nyxol in September 2022. (via)
Didn’t I just hear about Nyxol in the news?
You did! Ocuphire entered into a global licensing agreement with FamyGen Life Sciences—recently purchased by Viatris—in November 2022 for the exclusive rights to develop and commercialize Nyxol. (via)The company also submitted a NDA for Nyxol in December 2022 to the FDA for its first indication, reversal of pharmacologically-induced mydriasis. (via)
How did it perform in previous trials for presbyopia?
The VEGA-1 (NCT04675151) phase 2 trial showed that Nyxol—alone and in combination with low-dose (0.4%) pilocarpine (LDP)—moderately reduced pupil diameter and sustained 18-hour duration of efficacy, leading to potentially better contrast sensitivity and visual acuity.
What does the phase 3 trial include?
VEGA-2 is a randomized, double-masked, placebo-controlled, multi-center study evaluating the safety and efficacy of Nyxol in two labels: Nyxol alone and Nyxol with adjunctive LDP therapy for presbyopia.
A total of 320 patients will be enrolled, split into two stages. Stage 1 includes two treatment groups—Nyxol or placebo—with an estimated 160 participants in each group. Stage 2 includes four treatment groups with approximately 80 participants in each: Nyxol + LDP; Nyxol + LPD vehicle; placebo + LDP; and placebo + LPD vehicle.
What’s the intent?
By further decreasing the pupil size with Nyxol in combination with a low-dose miotic agent, a “pinhole effect” may be achieved that could lead to improved depth of focus and near reading vision. Jay Pepose MD, PhD, Ocuphire’s chief medical advisor, posited that there is a potential to customize this treatment based on the patient’s lifestyle.
Any other developments?
Ocuphire expects to initiate a second phase 3 trial for presbyopia (VEGA-3) and one-year safety study (LYRA-1) in 2023.