Opus Genetics today made 3 big announcements on the progress of its phentolamine ophthalmic solution 0.75% for the treatment of presbyopia:

1. Completion of enrollment in the VEGA-3 randomized, placebo-controlled, double-masked, multi-center phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia. According to a company press release, 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 US investigational sites.
2. Enrollment in the LYNX-2 pivotal phase 3 trial, evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of visual loss in low light conditions associated with keratorefractive surgery, is well underway, with more than 95% of its target enrollment met. Opus anticipates completion of enrollment in the first half of 2025. 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.
3. The FDA has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% 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 (ie, 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.

Phentolamine ophthalmic solution 0.75% is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. According to a company press release, it works by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors, without affecting the ciliary muscle. 

“Phentolamine ophthalmic solution 0.75% has the potential to transform how [presbyopia] is managed by offering a durable, non-invasive solution that improves near vision, without compromising nighttime distance vision,” said Jay Pepose, MD, PhD, chief medical advisor at Opus Genetics  “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.”