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.
“Any patient who has had a routine eye exam has experienced the frustrations that come with prolonged dilation, and many request some form of reversal agent. As of now, we have no current commercially available options to offer, so we are excited to start this Phase 3 registration trial to evaluate Nyxol as a potential reversal agent,” said Paul Karpecki, OD, Director of Cornea Services for Kentucky Eye Institute in Lexington KY.
Mina Sooch, President and CEO of Ocuphire Pharma added, “With so many eye exams performed every year that require dilation, there is a clear need for a safe and effective option to accelerate the return of patients to their daily activities and everyday vision. We designed the MIRA-2 Phase 3 trial to build on the positive results of our recently completed Phase 2b MIRA-1 trial which were presented at ARVO in May 2020. This is the first of our four planned clinical trials for Nyxol and APX3330. We are at various stages of start-up activities across these trials, and look forward to timely enrollment on this MIRA-2 Phase 3 trial in collaboration with our CRO partner, Oculos Development Services.”
Ocuphire is also pleased to announce the acceptance of a peer-reviewed written publication of the MIRA-1 study “Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial” in Optometry and Vision Science (OVS), Journal of the American Academy of Optometry. Accepted articles will appear soon in print and on-line at www.optvissci.com.