Ocuphire Pharma Announces First Patient Enrolled in MIRA-2 Phase 3 Clinical Trial Investigating Nyxol for Reversal of Mydriasis
Begins Enrollment in the First of Four Upcoming Late-Stage Trials in the U.S.
Announces MIRA-1 Phase 2b Study Accepted for Peer-Reviewed Publication in Optometry and Vision Science
FARMINGTON HILLS, Mich., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc., (Nasdaq: OCUP) a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, announced today the enrollment of the first patient in its MIRA-2 (NCT04620213) Phase 3 registration clinical trial evaluating the safety and efficacy of Nyxol to reverse pharmacologically-induced mydriasis. A majority of the 12 clinical sites located around the US are open and recruiting as of this week.
Approximately 100 million eye exams are performed annually in the U.S., most of which require dilation (mydriasis) of the pupil to properly examine the back of the eye. In addition, 4 million eyes are dilated each year for surgical procedures. This pharmacologically-induced dilation can last anywhere from 6 to 24 hours depending on individual patient characteristics. These dilated eyes have heightened sensitivity to light and inability to focus on near objects, causing patients difficulty with activities such as reading, working, and driving. In a recently completed market research study surveying several hundred patients and eye care providers (optometrists and ophthalmologists) conducted by GlobalData, an estimated 45% of patients were very likely to request a reversal drop and over 40% of eye care providers were likely to use a reversal drop if such a treatment option was approved and commercially available.
Nyxol, a proprietary and stable eye drop formulation of phentolamine mesylate, has demonstrated reversing mydriasis in a recently completed Phase 2b clinical trial (MIRA-1). Nyxol eye drops work by reducing pupil size through acting on the iris dilator muscle, allowing patients to return to their normal pupil size more rapidly. The objectives of the MIRA-2 trial are to evaluate the efficacy and safety of Nyxol compared to placebo in healthy patients to reverse pharmacologically-induced mydriasis across several commonly used mydriatic (dilating) drops. This 24-hour, multi-center, randomized, double-masked, placebo-controlled Phase 3 registration trial is expected to enroll 168 patients with top-line results expected in Q1 2021. This is the first of two registration trials planned in this acute indication for eventual New Drug Application (NDA) submission.