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FDA approves first presbyopia eye drop

US regulators have approved the country’s first presbyopia eye drop that adopts pupil constriction to improve near and intermediate vision while maintaining some pupillary response to different lighting conditions.

The daily prescription eye drop, Vuity (pilocarpine HCl ophthalmic solution) 1.25%, is produced by Allergan, a subsidiary of AbbVie, which announced the US Food and Drug Administration (FDA) clearance on 26 October.

According to the company, the topical therapy works in as early as 15 minutes and lasts up to six hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision.

It is said to feature an optimised formulation of pilocarpine, an established ophthalmic therapeutic, delivered with proprietary pHast technology that allows Vuity to rapidly adjust to the physiologic pH of the tear film. The therapy uses the eye’s own ability to reduce pupil size, improving near vision without affecting distance.

It is now the first and only FDA-approved eye drop to treat presbyopia, which affects 128 million Americans – nearly half of the US adult population. The primary mechanism of action is through pupil constriction to improve near and intermediate vision while maintaining some pupillary response to different lighting conditions – an effect known as dynamic pupil modulation

“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,” Dr Michael Severino, vice chairman and president of AbbVie, said.

“The FDA approval exemplifies our continued pursuit of innovative new treatments that push the boundaries of what’s possible in eyecare.”

The FDA approval 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 presbyopia. They involved 750 participants aged 40 to 55 with presbyopia randomised into either of the studies in a one-to-one ratio of placebo to Vuity.

In both studies, it 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 three.

There were no serious adverse events observed in participants receiving Vuity in either study. The most common adverse events occurring at a frequency of >5% were headache and eye redness.

“Vuity offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision,” said Dr George Waring, medical director of the Waring Vision Institute, South Carolina, and GEMINI 1 and GEMINI 2 principal study investigator.

“I am particularly encouraged by the rapid onset of action and duration of efficacy for Vuity to improve near and intermediate vision without impacting distance vision with one drop daily, particularly for those with mild to moderate presbyopia.”

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