Benzinga | Jan 6, 2021 07:10AM EST

Ocuphire Completes Enrollment in MIRA-2 Phase 3 Clinical Trial Investigating Nyxol for Reversal of Mydriasis

Nyxol has Potential to be a New Treatment Option for Reversal of Pharmacologically-Induced Pupil Dilation

Top-Line Data for MIRA-2 Expected by End of Q1 2021

FARMINGTON HILLS, Mich., Jan. 06, 2021 (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 that it has completed enrollment earlier than expected in its MIRA-2 (NCT04620213) Phase 3 registration clinical trial evaluating the safety and efficacy of Nyxol(r) to reverse pharmacologically-induced mydriasis.

"We are pleased to exceed our enrollment target and reach this important milestone in our Reversal of Mydriasis MIRA-2 program in just over 4 weeks despite the challenges presented by the COVID-19 pandemic," said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. "This current study builds on the positive results achieved in our recent Phase 2b MIRA-1 trial, which provided evidence of Nyxol's ability to more rapidly return pupil diameter back to normal baselines. MIRA-2 is the first completed trial of our four planned Phase 2 and 3 trials for Nyxol and APX3330 in the upcoming year, highlighting management's ability to execute on our strategic plan."

Every year in the U.S., approximately 100 million eye exams are performed that require dilation of the pupil (mydriasis) to examine the back of the eye either for routine check-ups, disease monitoring or surgical procedures. Depending on the individual and the color of their eyes, the pharmacologically-induced dilation can last anywhere from 6 to 24 hours. Dilated eyes have a heightened sensitivity to light and an inability to focus on near objects, causing difficulty with reading, working, and driving.

Ocuphire has been working closely with the market research firm GlobalData to survey several hundred patients and eye care providers (optometrists and ophthalmologists) about Reversal of Mydriasis (as well as Night Vision Disturbances and Presbyopia). Over 65% of surveyed patients reported moderate to severe negative impact of a dilated exam, underscoring the potential value of Nyxol's role in improving comfort and daily function after pupil dilation. Additionally, an estimated 45% of patients responded that they would be very likely to request a dilation reversal drop, and more than 40% of eye care providers would be likely to use a reversal drop if such a treatment were commercially available.

Nyxol is a proprietary, preservative-free, stable eye drop formulation of phentolamine mesylate that reduces pupil size through acting on the iris dilator muscle. It has been studied in seven Phase 1 and 2 trials that have characterized Nyxol's efficacy, durability, and tolerability product profile. One of these trials was MIRA-1, a randomized cross-over, double-masked, placebo-controlled, multi-center Phase 2 trial studying Nyxol in reversal of mydriasis. The results showed with statistical significance that, following pharmacologically-induced dilation, pupils treated with Nyxol returned to their normal size more rapidly than those with placebo. Highlights from this trial were presented by Dr. Paul Karpecki at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2020. 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. The article will appear soon in print and on-line at www.optvissci.com.

Jay S. Pepose, MD, PhD, Director of the Pepose Vision Institute, Professor of Clinical Ophthalmology at the Washington University School of Medicine, and Ocuphire Medical Advisory Board member commented, "Patients who have had a routine eye exam and request some form of dilation reversal agent currently have no commercially available option and may find driving home with blurry vision challenging. The MIRA-2 Phase 3 clinical trial is designed to confirm Nyxol's consistent and clinically relevant reduction in pupil diameter and overall safety profile demonstrated in earlier registered trials and to support the product's potential commercialization and adoption in eye care practices."

MIRA-2 trial is designed to evaluate the efficacy and safety of Nyxol compared to placebo in healthy subjects who had received mydriatic (dilating) drops. A total of 185 healthy pediatric and adult subjects (target of 168) were enrolled into this 24-hour, multi-center, randomized, double-masked, placebo-controlled Phase 3 trial. At the treatment visit, subjects who have been randomized and also stratified by iris color are administered one of three approved mydriatic agents (phenylephrine, tropicamide, or Paremyd(r)) approximately 1 hour prior to receiving study treatment with either Nyxol or placebo. The primary endpoint is the percentage of subjects returning to their baseline pupil diameter within 90 minutes. Top-line results are expected by the end of Q1 2021. MIRA-2 is the first of two registration trials planned for Nyxol in this acute indication prior to submission of a New Drug Application.

Ocuphire is collaborating closely with Oculos Development Services, a Tampa, Florida based clinical research organization and subsidiary of Iuvo BioScience, on the launch and execution of the MIRA-2 trial. "We are pleased by the rapid enrollment in this Phase 3 trial, which speaks to the unmet need. We thank our investigators, clinical coordinators, staff, and subjects for their support and ease of trial execution at 12 sites across the U.S.," said Chuck Slonim, MD, Chief Medical Officer and Medical Monitor of Oculos.

For more information about the MIRA-2 Phase 3 trial design and its U.S. clinical sites, please visit www.clinicaltrials.gov (NCT04620213).