Opus Genetics Announces FDA Fast Track and Enrollment Updates for Phentolamine

Opus Genetics announced completion of enrollment in the VEGA-3 phase 3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia. Opus also announced that enrollment in the LYNX-2 pivotal phase 3 trial, evaluating phentolamine for the treatment of visual loss in low light conditions associated with keratorefractive surgery, is underway with anticipated completion of enrollment in the first half of 2025.

In addition, the FDA has granted fast track designation for phentolamine as treatment of significant chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena (i.e., glare, halos, starburst). Fast track status is designated to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

“We are pleased with the ongoing progress of both the VEGA-3 and LYNX-2 studies,” Jay Pepose, MD, PhD, Chief Medical Advisor at Opus Genetics, said in a company news release. “Presbyopia affects millions of people and represents a daily challenge that can diminish independence and quality of life. phentolamine ophthalmic solution 0.75% has the potential to transform how this condition is managed by offering a durable, noninvasive solution that improves near vision, without compromising nighttime distance vision. It also offers the potential to improve visual performance in patients who have undergone LASIK for vision correction, and who now have difficulty with low light vision and night-time vision disturbances. We look forward to sharing the results of these important studies and working with our partner to complete development in these two indications.”

VEGA-3 Phase 3 Program in Presbyopia

VEGA-3 is a randomized, double-masked, placebo-controlled, multicenter, phase 3 clinical trial evaluating phentolamine ophthalmic solution 0.75% in 545 participants with presbyopia. The primary endpoint is the percentage of participants with 15-letter improvement in photopic binocular distance-corrected near visual acuity (DCNVA) on the eighth day following their first visit. Participants are being followed a total of 48 weeks to collect chronic safety data. Recruitment has taken place at 39 investigational sites in the U.S.

For more information on the VEGA-3 trial design and endpoints, please refer to www.ClinicalTrials.gov (NCT06542497).

LYNX-2 Phase 3 Program in Dim Light Disturbances

LYNX-2 is a randomized, double-masked, placebo-controlled phase 3 clinical trial designed to evaluate phentolamine ophthalmic solution 0.75% compared to placebo in subjects who underwent keratorefractive surgery and then reported decreased visual acuity under low light conditions. Target enrollment is 200 subjects, and the trial is more than 95% enrolled. The primary endpoint is a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing.

The LYNX-2 trial is being conducted under conditions of a Special Protocol Assessment (SPA) with the FDA. Additional information about LYNX-2 can be found at www.clinicaltrials.govNCT06349759.

The FDA recently granted fast track designation for phentolamine ophthalmic solution 0.75% as treatment of significant chronic night driving impairment in keratorefractive patients with reduced mesopic vision and photic phenomena. This designation offers Opus Genetics several key benefits, including more frequent interactions with the FDA, eligibility for priority review, as well as rolling review, allowing sections of the NDA to be submitted and evaluated on an ongoing basis.