FDA Approves Mydriasis-Reversing Eye Drops


According to Viatris and Ocuphire Pharma, the FDA has approved phentolamine ophthalmic solution (Ryzumvi) 0.75% for treatment-induced mydriasis.

The approval specifies using the eye drops to control pupillary dilatation caused by parasympatholytic or adrenergic agonists. In the United States, an estimated 100 million people have thorough eye exams that involve mydriasis, or pupil dilation. Mydriasis, which can last up to 24 hours, can impair someone’s ability to read, work, and drive by causing light sensitivity, fuzzy vision, and other ocular adverse effects .The MIRA clinical trial program, which included four phase I–III clinical trials, including one study involving young patients, provided evidence in favor of the approval. The investigations involved more than 600 mydriasis patients overall, ranging in age from 12 to 80.

Phenylephrine, tropicamide, or a compound of hydroxyamphetamine hydrobromide and tropicamide can all cause mydriasis.

One hour after pupillary dilatation, study participants were randomly assigned to receive either phentolamine ophthalmic solution or a placebo. At assessments made one to 24 hours after the introduction of mydriasis in two phase III trialsopens in a new tab or window, significantly more individuals who received the active eye drops had baseline pupil diameter reductions to 0.2 mm (P 0.01). Similar efficacy was seen across all age groups according to subgroup analysis.

Stinging and burning (16%) and conjunctival hyperemia (12%) were the most frequently reported ocular adverse events (AEs) among patients treated with phentolamine ophthalmic solution. Dysgeusia (6%), the only non-ocular AE in the trials, was seen.

The firms’ statement claims that the main factor controlling pupillary dilatation

by the alpha-1 adrenergic receptors that activate the radial iris dilator muscles. To shrink the diameter of the pupil, phentolamine binds to receptors on the radial iris dilator muscles that surround it.

In the first half of 2024, according to company representatives, phentolamine eye drops will be made available in the United States.

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