FDA approved twice-daily dosing option for Vuity eye drops for presbyopia

The FDA has approved a twice-daily dosing option of pilocarpine HCl ophthalmic solution 1.25% (VUITY) for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults.

A second dose (one additional drop in each eye) may be administered 3 to 6 hours after the first dose. Presbyopia, or age-related blurry near vision, is a common and progressive eye condition that affects an estimated 128 million Americans, or nearly half of the U.S. adult population.

With the approval of twice-daily dosing, the duration of effect of VUITY may be extended for up to 9 hours. The approval is based on results from the double-masked Phase 3 VIRGO trial in which 230 participants aged 40 to 55 years old with presbyopia were randomized to pilocarpine HCl ophthalmic solution 1.25% (n=114) or placebo (vehicle alone, n=116), receiving 1 drop in each eye twice daily, with each dose administered 6 hours apart, for 14 days.

The primary endpoint of the proportion of participants gaining three lines (the ability to read three additional lines on a near vision chart) or more in mesopic (low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) with no more than 5-letter loss in low light Corrected Distance Visual Acuity (CDVA) at Day 14, Hour 9 (3 hours after the second drop) versus the vehicle (placebo) was met (35.1% vs 7.8%, p<0.0001).

The most common adverse reactions reported in >5% of participants were headache and eye irritation. Ocular adverse reactions reported in 1-5% of participants were visual impairment, eye pain, blurred vision, and vitreous floaters.

VUITY is an optimized formulation of pilocarpine specifically designed to treat age-related blurry near vision. VUITY, previously FDA-approved for once-daily dosing in October 2021, uses the eye's ability to reduce pupil size, to improve near and intermediate vision while maintaining some pupillary response to light.

The solution is a prescription eye drop used to treat age-related blurry near vision (presbyopia) in adults.

The FDA approval of VUITY is based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety and tolerability of VUITY for the treatment of presbyopia. In both studies, the drops met the primary endpoint, reaching statistical significance in improvement in near vision in low light (mesopic) conditions without a loss of distance vision versus the vehicle (placebo) on day 30 at hour 3. Additionally, improvement was seen as early as 15 minutes and lasted through 6 hours. There were no serious adverse events observed in participants receiving VUITY in either the GEMINI 1 or GEMINI 2 study. The most common adverse events occurring at a frequency of >5% were headache and eye redness.

In the Phase 3 GEMINI 1 and GEMINI 2 clinical studies, a total of 750 participants aged 40 to 55 years old with presbyopia were randomized in the two studies in a one-to-one ratio of placebo to pilocarpine HCl ophthalmic solution 1.25%.

According to the company, study participants were instructed to administer one drop of VUITY or placebo once daily in each eye.

Both studies met their primary endpoints with a statistically significant proportion of participants treated with VUITY gaining three lines (the ability to read three additional lines on a reading chart) or more in mesopic (in low light), high contrast, binocular distance corrected near visual acuity (DCNVA), without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) at day 30, hour 3, versus placebo.

There were no serious adverse events observed in any participants treated with pilocarpine HCl ophthalmic solution 1.25% VUITY in either clinical study. The most common treatment-emergent non-serious adverse events occurring at a frequency of >5% in participants treated with pilocarpine HCl ophthalmic solution 1.25% were headache and eye redness.