Allergan, an AbbVie company, announced in a press release that the FDA has approved VUITY (pilocarpine HCl ophthalmic solution 1.25%) for the treatment of presbyopia, commonly known as age-related blurry near vision in adults.
According to the company, VUITY is the first and only FDA-approved eye drop to treat this prevalent and degenerative eye illness that affects 128 million Americans.
VUITY is a prescription eye drop that improves near and intermediate vision without affecting distance vision. It works in as little as 15 minutes and lasts up to 6 hours, as measured on day 30.
The pHast technology allows VUITY adjust to the physiologic pH of the tear film. VUITY improves close vision without impairing far vision by utilizing the eye's innate capacity to lower pupil size.
"Most adults cope with presbyopia, or difficulty with near vision, as we age. Beginning around the age of 40, many find themselves using reading glasses, holding text further away, or even increasing the font size and lighting on screens to try to see more clearly," Michael Severino, MD, vice chairman and president, AbbVie, said in a company news release.
"We are proud to offer Vuity as a first-of-its-kind once-daily eye drop that we believe will change the way people and their eye doctors approach presbyopia. The FDA approval of Vuity exemplifies our continued pursuit of innovative new treatments that push the boundaries of what's possible in eye care."
Vuity received FDA approval based on results from two major phase 3 clinical studies, GEMINI 1 and GEMINI 2, that assessed the efficacy, safety, and tolerability of Vuity for the treatment of presbyopia.
Vuity met the primary goal in both studies, achieving statistical significance in near vision improvement in low light (mesopic) circumstances without a loss of distant vision versus the vehicle (placebo) on day 30 at hour 3 versus the vehicle (placebo).
Improvement was also visible as early as 15 minutes and lasted for 6 hours. In either the GEMINI 1 or GEMINI 2 studies, there were no major adverse events reported in subjects who received Vuity.
Headache and eye redness were the most prevalent side effects, with a frequency of >5%.
Highlights from the Phase 3 GEMINI 1 & 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 Vuity.
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 Vuity in either clinical study. The most common treatment emergent non-serious adverse events occurring at a frequency of >5% in participants treated with Vuity were headache and eye redness.