EYECARE Vuity, First and Only FDA-Approved Eye Drop to Treat Presbyopia, Is Now Available By Staff Friday, December 10, 2021 12:24 AM NORTH CHICAGO, Ill.—Allergan, an AbbVie company, yesterday announced 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 nationwide. "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, Allergan's senior vice president, medical therapeutics."This significant innovation in age-related eye health reflects our commitment to advance vision care and expands our leading portfolio of treatments for eyecare providers and their patients," Dosanjh said. Selina McGee, OD, a fellow of the American Academy of Optometry, commented, "Many Americans deal with presbyopia, which typically begins around age 40, by relying on reading glasses or resorting to work-arounds like zooming in on their digital devices to see up close. As an optometrist who also has presbyopia, I'm personally and professionally excited to try Vuity for myself, as well as offer it to my patients with age-related blurry near vision. With Vuity now available, it is a good time for those who experience age-related blurry near vision to visit their eye doctor for an exam and to discuss their options to manage this common condition." Vuity is an optimized formulation of pilocarpine, an established eyecare 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, Allergan reported. 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. "As I've gotten older, my vision has changed, and it has become almost impossible to see clearly up close unless I wear my readers. Realizing that I needed to start using readers showed me how important it was to address this condition," said Toni Wright, clinical trial participant. "It was great to have the opportunity to participate in the clinical study investigating a new potential treatment option. I'm so excited that the investigational treatment, which has been identified as Vuity, is now approved and available as a treatment to manage age-related blurry near vision," Wright said.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. There were no serious adverse events observed in any participants treated with Vuity in either clinical study. The most common adverse events occurring at a frequency of >5% in participants treated with Vuity were headache and eye redness.