First patient enrolled in LYNX-2 Phase 3 study

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Ocuphire Pharma Inc announced the enrollment of the first subject in the LYNX-2 Phase 3 registration study evaluating phentolamine ophthalmic solution 0.75% (PS) for the treatment of decreased visual acuity under low (mesopic) light conditions following keratorefractive surgery.

The LYNX-2 trial (NCT06349759) is being conducted under conditions of a Special Protocol Assessment (SPA) with the FDA.

According to the company, LYNX-2 is a randomly assigned, double-masked, placebo-controlled Phase 3 registration study designed to evaluate the safety and efficacy of PS.¹

The company noted in its news release the trial is expected to enroll 200 subjects. The primary endpoint agreed with the FDA under the SPA, will be 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.

As previously announced, Ocuphire received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial would adequately address objectives supporting regulatory submission and a potential future marketing application in this indication.

George Magrath, MD, MBA, MS, CEO of Ocuphire, pointed out in a news release that the company was pleased to kick off enrollment in the LYNX-2 study of PS.¹

“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,” he said in the news release. “We believe that PS is a product with broad potential applications in ophthalmology. Having already received approval for Ryzumvi to treat pharmacologically-induced mydriasis, our partner Viatris, Inc. (Viatris) now has the opportunity to create further value as it pursues additional indications for PS, which also include presbyopia.”

The company noted in its news release that vision disturbances under low light conditions are characterized by peripheral corneal imperfections (aberrations) that result in unfocused light when the pupil dilates under low light conditions. Patients diagnosed with this condition experience decreased low-contrast visual acuity as well as glare, halos and starbursts.¹

Patients undergoing keratorefractive surgery (including LASIK, PRK, SMILE, and RK) have been identified as one of the major sub-populations affected, the others being those who have night myopia (naturally occurring), non-central cortical cataracts, keratoconus or post-multifocal or extended depth of focus intraocular lens (IOL) implantation.¹

The company noted in its news release there are no FDA-approved treatments for visual disturbances under low light conditions. With a mechanism of action that moderately reduces pupil size without the increased risks of retinal tears or detachment associated with parasympathomimetic miotics that engage the ciliary muscle, PS eye drops have the potential to be a treatment option that could improve patients’ ability to see and function in low light.

Moreover, according to the news release, Ocuphire’s previous LYNX-1 Phase 3 study evaluating PS successfully met its primary endpoint, with 13% of subjects gaining 15 or more ETDRS letters of mesopic low contrast distance visual acuity at Day 8 vs. 3% on placebo (p < 0.05).

The company noted in its news release that PS is manufactured as a preservative-free eye drop, which could facilitate its use while avoiding the common side effects of preservatives, such as ocular surface damage, eye irritation and tear film instability.

Jay Pepose, MD, PhD, chief medical advisor at Ocuphire, pointed out that low light vision disturbances often 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.

“This represents a significant, yet often overlooked sequela of LASIK or other forms of keratorefractive surgery,” he said in the news release.

Despite the success and popularity of LASIK for vision correction, Pepose pointed out that a subset of patients find themselves grappling with these low light or night-time vision challenges, for which there has been no specific, targeted treatment available.

“If approved, PS offers the potential to enhance visual performance in low light conditions and restore a sense of normalcy and confidence in these patients,” he added.

Ocuphire noted in its news release it has a global license agreement with Viatris to co-develop and commercialize PS for the reversal of mydriasis, presbyopia and low light vision disturbances. Under the terms of this agreement, the two companies agreed to co-develop the product for each of these conditions, with Viatris providing funding for development of these programs.

Further, Ocuphire is eligible to receive specified regulatory or net sales milestone payments associated with these indications as well as royalties on commercial sales. In September 2023, Ocuphire met the $10 million milestone payment requirements attributed to the FDA’s approval of PS for reversal of mydriasis.¹

Reference:

1. Pharma O. First Patient Enrolled in LYNX-2 Phase 3 Study Evaluating Phentolamine Ophthalmic Solution 0.75% (PS) for the Treatment of Decreased Visual Acuity Under Low Light Conditions Following Keratorefractive Surgery. GlobeNewswire News Room. Published April 11, 2024. Accessed April 11, 2024. https://www.globenewswire.com/news-release/2024/04/11/2861621/0/en/First-Patient-Enrolled-in-LYNX-2-Phase-3-Study-Evaluating-Phentolamine-Ophthalmic-Solution-0-75-PS-for-the-Treatment-of-Decreased-Visual-Acuity-Under-Low-Light-Conditions-Following.html