First patient enrolled LYNX-2 study of eye drop for reduced visual acuity in low light
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Key takeaways:
- The LYNX-2 study is being conducted under conditions of a special protocol assessment with the FDA.
- Phentolamine ophthalmic solution 0.75% is being evaluated for reduced visual acuity under low-light conditions.
Ocuphire Pharma has enrolled the first patient in its LYNX-2 phase 3 registration study of phentolamine ophthalmic solution 0.75% for treatment of reduced visual acuity under low-light conditions after keratorefractive surgery.
According to a company press release, patients who have undergone keratorefractive surgery are one of the major subpopulations affected by vision disturbances in low-light conditions and may experience reduced low-contrast visual acuity, glare, halos and starbursts. Individuals with naturally occurring night myopia, noncentral cortical cataracts, keratoconus, or post-multifocal or extended depth of focus IOL implantation may also be affected.
“Low-light vision disturbances are characterized by difficulty in distinguishing objects with subtle differences in contrast, such as a pedestrian in a crosswalk at dusk or on a rainy day under low-light conditions,” Jay Pepose, MD, PhD, Ocuphire’s chief medical advisor, said in the release. “This represents a significant, yet often overlooked sequela of LASIK or other forms of keratorefractive surgery. Despite the success and popularity of LASIK for vision
correction, a subset of patients find themselves grappling with these low-light or nighttime vision challenges, for which there has been no specific, targeted treatment available.”
According to the release, phentolamine ophthalmic solution 0.75% is a preservative-free eye drop that moderately reduces pupil size, without the increased risk for retinal tears or detachment linked to parasympathomimetic miotics that engage the ciliary muscle. In the previous LYNX-1 trial, 13% of participants treated with phentolamine ophthalmic solution gained at least 15 ETDRS letters of mesopic low-contrast distance visual acuity at day 8 compared with 3% in the placebo group.
The LYNX-2 trial, which is expected to enroll 200 participants, is designed to evaluate the safety and efficacy of phentolamine ophthalmic solution vs. placebo among patients who underwent keratorefractive surgery and experienced reduced low-light visual acuity. The primary outcome is a gain of at least 15 letters in low-light conditions after 15 days of treatment.
The trial is being conducted under conditions of a special protocol assessment with the FDA, which states that the study’s protocol and analysis will address objectives to support regulatory submission and future marketing application, the release stated.
“We are pleased to begin enrollment in the LYNX-2 study of [phentolamine ophthalmic solution (PS)],” George Magrath, MD, MBA, MS, Ocuphire’s CEO said in the release. “If our registration program meets expectations, and PS is subsequently approved by the FDA, it could potentially be the first commercial treatment for patients who have undergone LASIK surgery and experience low-light visual disturbances.”
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