FDA Approves Ocuphire's LYNX-2 Trial for Dim Light Vision Loss Treatment

Ocuphire Pharma, a biopharmaceutical company, has secured FDA approval for its clinical trial protocol for the LYNX-2 Phase 3 trial. The trial will assess the efficacy of a phentolamine ophthalmic solution in treating decreased visual acuity under low light conditions. CEO George Magrath highlighted the significance of this agreement, which sets a clear path for the treatment of poor night vision post-keratorefractive surgery. The LYNX-2 trial is set to begin in early 2024, aiming to enroll patients and evaluate the impact of the solution on night vision disturbances, such as glare and reduced contrast, especially during nighttime driving.

Marguerite McDonald, a Clinical Professor of Ophthalmology, underscored the absence of FDA-approved treatments for night vision issues and expressed optimism for the potential of phentolamine ophthalmic solution. The treatment works by reducing pupil size without engaging the ciliary muscle, a feature that differentiates it from other miotics by avoiding overly constricted pupils that can degrade vision.

The LYNX-2 trial will be a multi-center, randomized, double-masked, placebo-controlled study involving up to 200 U.S. patients. The primary endpoint will measure the improvement in distance vision on a low contrast chart after 15 days of treatment. The FDA's written agreement confirms that the trial's design and analysis can support regulatory submission and a potential marketing application.

Viatris will fund the development of the phentolamine solution for treating both decreased visual acuity in dim light and presbyopia, with Ocuphire eligible for milestone payments upon FDA approvals.

Ocuphire is also developing APX3330, a novel small-molecule inhibitor of Ref-1, which plays a role in regulating VEGF and inflammatory cytokines. This oral tablet is intended for diabetic retinopathy treatment, aiming to normalize VEGF levels and delay or prevent the progression of the disease, thereby reducing the need for frequent eye injections.

The company has also licensed APX2009 and APX2014, which have potential applications in treating other retinal diseases. Ocuphire is exploring local delivery routes in addition to oral administration as part of its retinal therapy expansion.

In September 2023, the FDA approved RYZUMVI™, a phentolamine ophthalmic solution, for the treatment of pharmacologically induced mydriasis. The solution is also in Phase 3 development for presbyopia and dim light visual acuity treatment.

Ocuphire's commitment to developing innovative ophthalmic treatments reflects its dedication to improving patient outcomes and addressing unmet needs in eye care.