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# Eye Dilation Reversal Drops Approved
- URL: https://www.fdaweb.com/eye-dilation-reversal-drops-approved/
- Published: 2023-09-27T12:00:00.000Z
- Updated: 2026-09-14T18:58:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155428

FDA has approved a Viatris and Ocuphire Pharma NDA for Ryzumvi (phentolamine ophthalmic solution) 0.75% for treating pharmacologically-induced mydriasis (dilation) produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. The companies say about 100 million eye exams are conducted each year that involve pharmacologically-induced mydriasis of the pupils, which can last up to 24 hours and cause sensitivity to light and blurred vision.

Approval was based on data from the MIRA clinical trial program involving more than 600 patients. Data from the trials showed that the percentage of subjects with study eyes returning to near the 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...,” the companies say.

Regarding safety, they say the most common ocular adverse reactions reported in more than 5% of subjects were instillation site discomfort including pain, stinging and burning (16%) and conjunctival hyperemia (12%).

Viatris and Ocuphire describe Ryzumvi as a non-selective alpha-1 and alpha-2 adrenergic agonist. “Dilation of the pupil is primarily controlled by the radial iris dilator muscles surrounding the pupil; these muscles are activated by the alpha-1 adrenergic receptors,” they say. “Phentolamine reversibly binds to these receptors on the iris dilator muscle, thereby reducing pupil diameter.”