Ocuphire Completes Enrollment in VEGA-1 Phase 2 Trial Investigating Nyxol in Combination with Low-Dose Pilocarpine for Treatment of Presbyopia
Ocuphire Pharma announced that it has completed enrollment in the VEGA-1 phase 2 clinical trial (NCT04675151) evaluating the safety and efficacy of a combination kit of Nyxol and low-dose pilocarpine in presbyopia. VEGA-1 successfully recruited 150 subjects in just under 3 months.
“Achieving our enrollment completion target for the VEGA-1 trial is yet another important milestone in our Nyxol program and tracks for topline results by the end of June,” Mina Sooch, MBA, President and CEO of Ocuphire Pharma, said in a company news release. “Nyxol has the potential to address multiple unmet needs initially with the large market opportunity in reversal of mydriasis supported by our recent positive phase 3 data results and then adding this very large presbyopia market opportunity that is estimated at over $5 billion in the US alone. We are excited to develop Nyxol with low-dose pilocarpine as a potential option for the growing number of presbyopic patients and to also realize commercial synergies if products are approved given the common targeted optometrists and ophthalmologists.”
Marguerite McDonald, MD, FACS, Clinical Professor of Ophthalmology at the NYU Langone Medical Center and Ocuphire Medical Advisory Board member, stated, “Presbyopia is a condition that affects nearly everyone over the age of 40. Many patients reliant on reading glasses and contact lenses desire more flexibility and convenience and continually request alternatives or a complementary choice. Development of eyedrop treatments for Presbyopia has recently become very active, led by Allergan having recently submitted an NDA for this indication. There is room for many options given the large unmet need, and I am encouraged by Nyxol eye drops in combination with low-dose pilocarpine eye drops as a differentiated solution that works both on the iris dilator and sphincter muscles. This combination product should allow for moderate unopposed pupil constriction and provide the ability to see both at near and at distance without the side-effects such as brow ache, headache, blurry vision, and loss of distance night vision associated with the use of higher doses of pilocarpine.”
Based on a GlobalData market research report, 69% of patients would consider an eye drop as an alternative to reading glasses. Importantly, over 70% of patients indicated that they wear reading glasses in the morning, afternoon, and evening, suggesting that patients desire a solution with durability. Over 50% of responders also indicated that using drops 2 to 4 times per day would be moderately to very convenient to them. In addition, 66% of surveyed eyecare providers indicated interest in a Nyxol and low-dose pilocarpine product profile as a potential therapeutic alternative to reading glasses.
About VEGA-1 Phase 2 Clinical Trial
The VEGA-1 clinical trial is designed to evaluate the efficacy and safety of Nyxol in combination with low-dose pilocarpine compared to placebo in presbyopic subjects. A total of 150 subjects (planned target was 140 to 152) have been enrolled at 17 investigational sites in the US from mid-February to mid-May this year. The Phase 2 trial is randomized, double-masked, placebo-controlled with 4 treatment arms. At the first visit, subjects are randomized to receive either Nyxol or placebo drops that are instilled at home near bedtime for 3 to 4 days prior to Visit 2; at Visit 2 subjects then receive either low-dose pilocarpine or no treatment with efficacy and safety measurements collected at multiple timepoints through 6 hours. The primary endpoint is the percentage of subjects with ≥ 15 letters of improvement in photopic binocular near vision (i.e. distance-corrected near visually acuity, DCNVA) at 1 hour on Visit 2 for Nyxol + low-dose pilocarpine arm compared to placebo alone arm. Secondary endpoints at multiple timepoints include improvements of 3 lines of DCNVA without any loss of distance vision, pupil diameter, and improvements of DCNVA at 1 and 2 lines compared to placebo as well as to each Nyxol and low-dose pilocarpine alone. Top-line results are expected by the end of Q2 2021.