Ocuphire Pharma announced that it has enrolled the first patients in a phase 2 proof of concept trial, titled VEGA-1, to evaluate a combination kit of Nyxol and low-dose pilocarpine in presbyopia. Over 12 sites representing a majority of the planned clinical sites are activated and recruiting patients.
Nyxol’s potential to improve near vision is based on its mechanism of reducing pupil diameter which results in an increased depth of focus. Nyxol alone in multiple phase 2 trials has reduced pupil diameter by approximately 20% and has significantly improved near visual acuity by one eye-chart line for over 24 hours after an evening eye drop. It has been well established by the field that reducing pupil diameter to the 1.6 to 2.0 mm range (pinhole effect) can lead to significant improvements in near vision for presbyopic patients. Nyxol is being evaluated as part of a two-drug kit provided to patients, with Nyxol to be applied once daily in the evening and low-dose pilocarpine to be dosed in the daytime.
According to a market research report by GlobalData, 40% of patients would request an alternative to reading glasses if available and 69% of patients would consider an eye drop alternative. Some key factors that will influence patient adoption will be efficacy, tolerability, comfort, onset of action, durability, and good distance vision.
“Presbyopia could be one of the largest patient populations at over 100 million to be treated with a pharmacologic option. Many people with presbyopia may greatly benefit from an eye drop treatment as an alternative to reading glasses,” Mina Sooch, MBA, President and CEO of Ocuphire Pharma, said in a company news release. “We believe that the combination of Nyxol and low-dose pilocarpine has an ideal product profile to become a promising treatment for presbyopia. We are pleased to begin enrollment in the VEGA-1 clinical trial working with our CRO partner Oculos and look forward to reporting results at the end of the second quarter this year. This is our 3rd later stage clinical trial launched for Nyxol in just the last few months.”
“I am very happy to see that the VEGA-1 trial has begun enrollment, which brings the potential for Nyxol and low-dose pilocarpine eye drops to allow presbyopia patients to experience the ability to see both at near and at distance without the dependence on reading glasses,” Marguerite McDonald, MD, Clinical Professor of Ophthalmology at the NYU Langone Medical Center, said in the news release. “The combination of Nyxol moderately inhibiting the iris dilator muscle and low dose of pilocarpine, an extensively studied miotic, moderately activating the iris constrictor muscle should allow for unopposed pupil constriction to reach the ‘pin-hole’. Ocuphire’s use of agents working on both iris muscles to manage pupil size is a key differentiating factor for its approach.”
VEGA-1 is a double-masked, randomized, placebo-controlled, multi-center trial designed to evaluate 0.75% Nyxol in combination with low dose (0.4%) pilocarpine for treatment of presbyopia. The trial is expected to enroll approximately 152 patients with a clinical diagnosis of presbyopia (near visual acuity of 20/50 or worse). The primary endpoint is percentage of patients with at least 3 lines (15 letters or more) of binocular distance corrected near visual acuity (DCNVA) improvement on a standard near vision eye chart in daytime (photopic) lighting conditions. Secondary endpoints at multiple timepoints include improvements in 3 lines of DCNVA without any loss of distance vision, pupil diameter, and improvements in DCNVA at 1 and 2 lines compared to placebo as well as to each Nyxol and low-dose pilocarpine alone.
For more information refer to ClinicalTrials.gov Identifier: NCT04675151.