Opus Genetics provides FDA Fast Track, enrollment updates on phentolamine ophthalmic solution 0.75% programs

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Clinical stage ophthalmic biotechnology company Opus Genetics has provided enrollment updates for its LYNX-2 pivotal Phase 3 and VEGA-3 pivotal Phase 3 trials, in addition to a US FDA Fast Track Designation granted for phentolamine ophthalmic solution 0.75% for the treatment of significant chronic night driving impairment in keratorefractive patients with reduced mesopic vision and photic phenomena.¹ Enrollment for the VEGA-3 trial is complete and is evaluating phentolamine 0.75% for presbyopia, with the LYNX-2 trial enrollment underway with anticipated completion in H1 2025 to evaluate the same solution dosage for treatment of visual loss in low light conditions associated with keratorefractive surgery, according to a news release.

“We are pleased with the ongoing progress of both the VEGA-3 and LYNX-2 studies,” said Jay Pepose, MD, PhD, chief medical advisor at Opus Genetics, in the 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, non-invasive 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.”

Phentolamine 0.75% works as a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size by blocking alpha-1 receptors found on the radial iris dilator muscles without affecting the ciliary muscle. The radial iris dilator muscles are activated by the alpha-1 adrenergic receptors.¹

VEGA-3 is a randomized, double-masked, placebo-controlled, multicenter Phase 3 clinical trial with 545 participants with presbyopia. The trial’s primary endpoint is the percentage of participants with 15 letter improvement with photopic binocular distance-corrected near visual acuity on the eighth day following their first visit. Participants will then be followed for a total of 48 weeks to collect chronic safety data. Recruitment has taken place at 39 investigational sites in the US.¹

For the LYNX-2 randomized, double-masked, placebo-controlled Phase 3 trial, the target enrollment is 200 participants, with the trial already being 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 with the FDA.¹

In part of the recent Fast Track Designation phentolamine 0.75% for chronic night driving impairment in keratorefractive patients, Opus Genetics will be in more frequent contact with the FDA, is eligible for Priority Review and rolling review, the latter of which will allow sections of the NDA to be submitted and evaluating on an ongoing basis.¹

Reference:

1. Opus Genetics announces FDA Fast Track and enrollment updates for phentolamine ophthalmic solution 0.75% programs. News release. Opus Genetics. February 26, 2025. Accessed February 27, 2025. https://ir.opusgtx.com/press-releases/detail/475/opus-genetics-announces-fda-fast-track-and-enrollment-updates-for-phentolamine-ophthalmic-solution-0-75-programs