‘I did, not I wish’: Mydriasis reversal will hasten return to real life
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Three years ago, tragedy struck my family with the loss of my brother due to metastatic lung cancer.
My brother tried to protect us by not telling his fate until 24 hours before his final moments on Earth. His last words to me were: “When it is your time, my brother, remember to never say I wish, but say I did.” This year as a professional DJ in my other life, playing at major clubs and venues in Chicago, the theme of my tour has been #IDID #NOTIWISH. Most of my monies collected as a DJ have gone to a variety of eye charities and foundations to raise awareness of this theme.
I bring up this personal tribute to my younger brother only because it resonates closely to what I do for my real profession as a premium eye surgeon. Recently, Nyxol (phentolamine mesylate, Ocuphire) for the reversal of mydriasis met all of its endpoints in a phase 3 trial. This product and its data reminded me not to be shortsighted in life and to get the rapid visual recovery needed to be functional immediately.
Bottom-up calculation of annual dilated eye exams
Based on the approximate 2 million units of mydriatic agents sold in 2020, the total number of annual dilated eye exams is approximately 101 million. With 46,000 optometrists, 18,000 ophthalmologists and 3,000 retina specialists, based on an average number of annual exams at 59 weeks, 88 weeks and 150 weeks, respectively, and each group dilating an estimated 50% of their patients, the data come out to 52 million, 38 million and 11 million dilated eye exams annually, respectively. A global data market research survey showed that 58% of eye care professionals would start prescribing Nyxol within 1 year, and 81% of patients would be more likely to schedule yearly eye exams with a mydriatic reversal eye drop. There are currently zero commercially available treatments for mydriasis reversal.
Topline MIRA-3 phase 3 results
The MIRA-3 phase 3 FDA clinical trial met its primary endpoint of percent of subjects returning to baseline photopic pupil diameter (within 0.2 mm) at 90 minutes, with 58% of subjects treated with Nyxol returning to within 0.2 mm or less of their baseline pupil diameter at 90 minutes compared with only 6% of subjects treated with placebo (P < .0001). In comparison, only 36% of placebo-treated subjects returned to baseline pupil diameter at 6 hours. The 1-hour data showed more patients responding to Nyxol (42%) than there were placebo subjects back to baseline pupil diameter at the 6-hour timepoint (36%). MIRA-3 data confirm the prior MIRA-2 phase 3 registration trial showing substantial benefit in accelerating reversal of mydriasis. The FDA new drug application filing for Nyxol in reversal of mydriasis is planned for later this year, and a potential launch date for the only commercially available dilation reversal drop will hopefully be in the latter half of 2023.
Real-life mydriasis reversal
For my patients and myself, these data are compelling, even more so when looking out to 24 hours when more than 20% of the placebo subjects still had dilated pupils. Approximately 4 hours were gained in time to return to normal pupil diameter overall across all mydriatic agents and iris colors.
In summary, the good news is that mydriasis reversal is coming soon to our premium patients so they can get back to real life faster after their exams instead of being shortsighted. We can continue to say, “I did, not I wish.” Get ready and stay healthy for DJMJ and the #IDID tour coming to AAO Chicago later this year.
- For more information:
- Mitchell A. Jackson, MD, can be reached at Jacksoneye, 300 N. Milwaukee Ave., Suite L, Lake Villa, IL 60046; email: mjlaserdoc@msn.com.
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