Benzinga | May 12, 2021 07:32AM EDT

Ocuphire Completes Enrollment In VEGA-1 Phase 2 Clinical Trial Investigating Nyxol In Combination With Low-Dose Pilocarpine For Treatment Of Presbyopia

Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, announced today 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(r) 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 top-line results by the end of June," said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. "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."

The global prevalence of presbyopia is estimated to be 2 billion. An estimated 120 million Americans live with presbyopia, a large prevalence that is expected to exceed 150 million by 2034. To assist with their near vision deficiencies, individuals with presbyopia use reading glasses and contact lenses, and in some cases undergo surgical interventions. However, there are currently no approved drug therapies for presbyopia. As there are several drawbacks to reading glasses and contact lenses, including inconvenience, eye strain, and night vision disturbances, eye drops are increasingly being explored as an alternative. As for payment, presbyopia corrective devices have been mostly out-of-pocket cash pay by patients.

Marguerite McDonald, M.D., F.A.C.S, 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.