FDA Approves First Eye Drop For Presbyopia
AbbVie subsidiary Allergan has received FDA approval for Vuity (pilocarpine HCl ophthalmic solution), a novel eye drop for treating presbyopia. This common age-related condition leads millions of middle-aged people to acquire reading glasses.
Vuity is a once-daily prescription eye drop.
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.
“We are pleased to be able to bring this first-of-its-kind treatment to market sooner than expected for the millions of Americans with presbyopia who may benefit from it,” said Jag Dosanjh, senior vice president of medical therapeutics, Allergan, in a press release.
Vuity uses Allergan’s proprietary pHast technology, which facilitates the eye drop’s ability to adapt to the physiologic pH of the tear film.
When developing Vuity, Allergan developed 16 eye drop formulations before settling on the now FDA-approved solution.
FDA reviewed data from two pivotal Phase 3 clinical trials known as GEMINI 1 and GEMINI 2 before approving Vuity.
Seen on Drug Discovery and Development: Article Link