Ocuphire Announces MIRA-2 Phase 3 Registration Trial for the Reversal of Mydriasis Meets Primary Endpoint - Seite 3

A more detailed presentation of the topline MIRA-2 results will be discussed on a conference call this morning and posted shortly thereafter to the Investors section of Ocuphire’s corporate website in the Events section. For more information about the MIRA-2 Phase 3 trial design and its 12 U.S. clinical sites, please visit www.clinicaltrials.gov (NCT04620213). Ocuphire collaborated closely with Oculos Development Services, a Tampa, Florida based clinical research organization and subsidiary of Iuvo BioScience, on the execution of the MIRA-2 trial.

Building on the positive results of this first completed Phase 3 registration trial for Nyxol (MIRA-2), a second Phase 3 registration trial (MIRA-3) is planned to initiate in the second half of this year. A New Drug Application (NDA) to obtain approval to market Nyxol for this pharmacologically induced mydriasis indication is expected to be submitted to the FDA in early 2023.

Full results from the MIRA-2 Phase 3 trial will be presented at an upcoming industry conference - 2021 ASCRS Annual Meeting July 23–27 in Las Vegas, Nevada. Ocuphire also plans to submit these Phase 3 results to a peer-reviewed journal for publication later this year.

Reversal of Mydriasis Market Opportunity

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 heightened sensitivity to light and an inability to focus on near objects, causing difficulty with reading, working, and driving.

Market research conducted by GlobalData surveyed 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. This underscores the potential value of the role of the investigational product candidate Nyxol 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.