FDA gives its blessing to Ocuphire Pharma’s special protocol assessment for LYNX-2 Phase 3 clinical trial

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Ocuphire Pharma Inc announced it has received agreement from the FDA under a Special Protocol Assessment (SPA) for the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial to evaluate phentolamine ophthalmic solution for the proposed indication for the treatment of decreased visual acuity under dim (mesopic) light conditions.

“The SPA agreement with the FDA provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery,” George Magrath, MD, MBA, MS, CEO of Ocuphire, said in a news release. “Preparations for the LYNX-2 Phase 3 trial have begun, and we anticipate patient enrollment to begin in the first quarter of 2024.”

Marguerite McDonald, MD, FACS, clinical professor of Ophthalmology at New York University’s Langone Medical Center and Tulane University Health Sciences Center, added in the news release that patients with night vision disturbances face a range of symptoms including glare, halos, starbursts and reduced contrast which affect the quality of vision especially while driving at night.

“Currently, there are no FDA-approved pharmacologic therapies to treat this condition that is routinely presented in our clinics,” she said in the news release.

McDonald added that as an individual involved with the development of phentolamine for more than 15 years, she is hopeful that “we might be closer to a treatment than ever and applaud Ocuphire for their commitment to developing a treatment for the keratorefractive patients using phentolamine ophthalmic solution 0.75% to reduce the pupil diameter without engaging the ciliary muscle.”

“A distinct attribute of phentolamine ophthalmic solution compared to other miotics in the class is that it does not make the pupil too small, which can decrease contrast and degrade vision,” she added.

According to the company, it obtained written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial of phentolamine ophthalmic solution could address any objectives supporting regulatory submission and a potential future marketing application in this indication.¹

Moreover, the company noted in its news release LYNX-2 will be a multi-center, randomly assigned, double-masked, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of phentolamine ophthalmic solution in up to 200 patients in the US.¹

The company added in its news release the agreed primary endpoint will be a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in dim light conditions after 15 days of dosing.

Under the terms of the November 2022 license agreement, the company noted in its news release that Viatris will fund the development of phentolamine ophthalmic solution for the treatment of decreased visual acuity under dim (mesopic) light conditions and presbyopia. Ocuphire is eligible to receive a milestone payment upon FDA approval in these indications.

Reference:

1. Pharma O. Ocuphire Pharma Receives FDA Agreement Under Special Protocol Assessment for LYNX-2 Phase 3 Trial of Phentolamine Ophthalmic Solution for the Treatment of Decreased Visual Acuity under Dim (mesopic) Light Conditions. GlobeNewswire News Room. Published January 4, 2024. Accessed January 4, 2024. https://www.globenewswire.com/news-release/2024/01/04/2803925/0/en/Ocuphire-Pharma-Receives-FDA-Agreement-Under-Special-Protocol-Assessment-for-LYNX-2-Phase-3-Trial-of-Phentolamine-Ophthalmic-Solution-for-the-Treatment-of-Decreased-Visual-Acuity-u.html