First Patient Joins LYNX-2 Trial for PS Eye Drops to Treat Low Light Vision Issues Post-LASIK

Ocuphire Pharma, a biopharmaceutical company, has reported positive results from the LYNX-1 Phase 3 clinical trial for Nyxol® eye drops, which are being developed to treat night vision disturbances (NVD). The trial demonstrated that Nyxol effectively improved low contrast distance vision under dim light conditions, with more subjects showing an improvement of 3 lines or more compared to those on a placebo. This marks the first successful Phase 3 trial for a treatment addressing NVD, which is characterized by glare, starbursts, or halos, and affects a large patient population.
The study was a randomized, double-masked, placebo-controlled design involving 145 participants who self-administered Nyxol or a placebo daily for 14 days. The primary endpoint was met with statistical significance, showing a greater percentage of improvement in visual acuity for Nyxol-treated subjects. Secondary endpoints also indicated a significant benefit, with the positive effects of Nyxol increasing over time. Importantly, Nyxol demonstrated a favorable safety profile, with no serious adverse events reported.
The successful results of the LYNX-1 trial further differentiate Nyxol from other presbyopia-correcting drops and contribute to the growing body of evidence supporting its safety and efficacy. This is the sixth consecutive positive efficacy readout for Nyxol in the past 15 months across various indications, including reversal of mydriasis and presbyopia. Ocuphire Pharma's CEO, Mina Sooch, expressed pride in the company's achievements and commitment to addressing vision problems for millions of patients.
The market opportunity for a treatment addressing NVD is significant, with an estimated 38 million individuals in the US affected, and currently, there is no FDA-approved treatment available. Ocuphire Pharma plans to present the LYNX-1 data at upcoming medical conferences and continues to advance its clinical priorities, including pivotal trials for presbyopia and the NDA submission for Nyxol in the reversal of mydriasis.
The company's lead product candidate, Nyxol eye drops, is a once-daily, preservative-free formulation designed to reduce pupil size and is being developed for several eye disorders. Ocuphire's second product candidate, APX3330, targets angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases. The company is publicly traded on NASDAQ and continues to explore opportunities for acquiring additional ophthalmic assets and seeking strategic partnerships for drug development and commercialization.