Allergan, an AbbVie (ABBV) company, announced Thursday that VUITY (pilocarpine HCl ophthalmic solution) 1.25%, the first and only eye drop approved by the U.S. Food and Drug Administration (FDA) to treat presbyopia, is now available by prescription in pharmacies across the U.S.
The FDA approval of VUITY in October 2021 was 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.
Presbyopia, or age-related blurry near vision, can be diagnosed through a basic eye exam by an eye doctor (optometrist or ophthalmologist) and is a common and progressive eye condition that affects 128 million Americans, or nearly half of the U.S. adult population, which typically begins around age 40.
VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHast technology, which allows VUITY to rapidly adjust to the physiologic pH of the tear film. This was studied in simulated tear film, and the clinical significance is unknown.
VUITY uses the eye's own ability to reduce pupil size, improving near and intermediate vision while maintaining distance vision.
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