Ocuphire Pharma and Viatris Receive FDA Approval of Ryzumvi for the Reversal of Pharmacologically-Induced Mydriasis

Ocuphire Pharma and Viatris announced that the FDA has approved Ryzumvi (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. 

Ryzumvi, formerly known as Nyxol, is expected to be commercially available in the US in the first half of 2024. It will be the only commercially available treatment option for the reversal of dilated eyes. Viatris stated that it is not sharing pricing information at this time and that ‘further information will be provided at product launch.’

“The FDA’s approval of Ryzumvi marks a significant milestone for our eye care division and underscores Viatris’ commitment to advancing eye care and enhancing access for both eye care professionals and patients,” Viatris Eye Care Division President Jeffrey Nau, PhD, said in a company news release. “Comprehensive dilated eye exams are vital for early detection of vision-compromising diseases. Our hope is that by addressing patient dilation barriers, we’re empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes. We look forward to launching Ryzumvi in the first half of next year, and to continuing to advance our robust eye care pipeline which is aimed at addressing a range of vision-related disorders."

In the US, an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically-induced mydriasis (or dilation) of the pupils[1], which can last up 24 hours[2]. Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia)[2] and blurred vision[2], which may make it difficult to read, work and drive.[3,4]

Ryzumvi was evaluated in the MIRA clinical trial program involving more than 600 subjects, including the MIRA-1 phase 2b trial, MIRA-2 and MIRA-3 phase 3 pivotal trials, and MIRA-4 phase 3 pediatric trial. In the MIRA-2 and MIRA-3 trials, a total of 553 subjects aged 12 to 80 years, who had mydriasis induced by instillation of phenylephrine or tropicamide or a combination of hydroxyamphetamine hydrobromide and tropicamide (Paremyd) were randomized. Two drops (study eye) or one drop (fellow eye) of Ryzumvi or placebo (vehicle) were administered 1 hour after instillation of the mydriatic agent. The percentage of subjects with study eyes returning to ≤0.2 mm from baseline pupil diameter was statistically significantly greater (P<0.01) at all time points measured from 60 minutes through 24 hours in the Ryzumvi group compared with the placebo (vehicle) group across both of the MIRA-2 and MIRA-3 trials. The efficacy of Ryzumvi was similar for all age ranges including pediatric subjects aged 3 to 17 years. Pediatric subjects aged 12 to 17 years (n=27) were treated in MIRA-2 and MIRA-3 and pediatric subjects, aged 3 to 11 years (n=11) were treated in MIRA-4.

The most common ocular adverse reactions reported in >5% of subjects were instillation site discomfort including pain, stinging and burning (16%), and conjunctival hyperemia (12%). The only nonocular adverse reaction reported in >5% of subjects was dysgeusia (6%).

In November 2022, Ocuphire Pharma announced it entered into an exclusive license agreement with FamyGen Life Sciences for the development and commercialization of Nyxol across three indications in US, Europe, Japan, India, China and other global markets. In a separate deal with Famy, Viatris, a global health care company, agreed to commercialize Nyxol following each regulatory approval. View EyewireTV's coverage of the deal here.

References

1 Wilson FA, Stimpson JP, Wang Y. Inconsistencies Exist in National Estimates of Eye Care Services Utilization in the United States. J Ophthalmol. 2015;2015:435606. doi: 10.1155/2015/435606. Epub 2015 Aug 9. PMID: 26346484; PMCID: PMC4546761
2 PARAMYD® (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25% US Prescribing Information. Somerset, NJ.: Akorn, Inc.; 2001.
3 Goel S, Maharajan P, Chua C, Dong B, Butcher M, Bagga P. Driving ability after pupillary dilatation. Eye (Lond). 2003 Aug;17(6):735-8. doi: 10.1038/sj.eye.6700490. PMID: 12928686
4 Siderov J, Bartlett JR, Madigan CJ. Pupillary dilation: the patient's perspective. Clinical and Experimental Optometry. 1996;79(2):62-66. doi: 10.1111/j.1444-0938.1996.tb04976.