Industry

Allergan gets USFDA nod for eye drop to treat blurry vision

This drug is a daily, prescription eye drop that works in as early as 15 minutes and lasts up to 6 hours

November 3, 2021

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USFDA Drug product Approval — USFDA Approval

Last Updated on December 31, 2023 by The Health Master

Allergan, an AbbVie company, announced the US Food and Drug Administration (USFDA) approval of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults.

Vuity is the first and only USFDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the US adult population.

“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,” said Michael Severino, M.D., vice chairman and president, AbbVie.

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“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 USFDA approval of Vuity exemplifies our continued pursuit of innovative new treatments that push the boundaries of what’s possible in eye care.”

Vuity is a daily, prescription eye drop that works in as early as 15 minutes and lasts up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision.

Specifically designed for presbyopia, Vuity is an optimized formulation of pilocarpine, an established eye care therapeutic, delivered with pHast technology. The proprietary pHast technology allows Vuity to rapidly adjust to the physiologic pH of the tear film. Vuity uses the eye’s own ability to reduce pupil size, improving near vision without affecting distance vision.

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The USFDA approval of Vuity is 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.

In both studies, Vuity 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 3.

Additionally, improvement was seen as early as 15 minutes and lasted through 6 hours. There were no serious adverse events observed in participants receiving Vuity in either the GEMINI 1 or GEMINI 2 study. The most common adverse events occurring at a frequency of >5% were headache and eye redness.

What is Presbyopia

Presbyopia, known as age-related blurry near vision, is a common and progressive eye condition that reduces the eye’s ability to focus on near objects and usually impacts people after age 40.

In a non-presbyopic eye, the clear lens behind the iris can change shape and focus light to the retina, making it easier to see things up close.

In a presbyopic eye, the clear lens hardens and does not change shape as easily, making it difficult to focus on near objects. Presbyopia can be diagnosed by an eye doctor (ophthalmologist /optometrist).

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