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 - Seite 2

There are currently 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. The 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). PS is manufactured as a preservative-free eye drop, which potentially allows for continued use while avoiding the common side effects of preservatives, such as ocular surface damage, eye irritation and tear film instability. For more information about the prior LYNX-1 Phase 3 study evaluating PS, please visit https://www.ocuphire.com/news-media/press-releases/detail/374/ocuphire ....

Jay Pepose, M.D., PhD., Chief Medical Advisor at Ocuphire, commented, “Low light vision disturbances 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. Despite the success and popularity of LASIK for vision correction, 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.”

Ocuphire 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.