Allergan Announces Phase 3 Results Showing Twice-Daily VUITY Enables Patients to Read Three Additional Lines on Vision Chart After Two Weeks

Today, Allergan, a subsidiary of AbbVie, announced that its Phase 3 clinical trial met the primary endpoint: using Vuity eye drops twice daily can continuously alleviate presbyopia symptoms.

Vuity is an innovative and optimized ophthalmic formulation of pilocarpine. Its primary mechanism of action is pupil constriction, enhancing depth of field and improving near and intermediate vision. In October last year, this eye drop was approved by the U.S. FDA for marketing, becoming the first eye drop to treat presbyopia.

Results published today are from a Phase 3 clinical trial called VIRGO, which recruited a total of 230 volunteers aged between 40 and 55 who had presbyopia symptoms. These patients were randomly divided into two groups: one group received treatment with Vuity, while the other received a placebo. In the Vuity group, volunteers used two drops per eye each day, with the second drop administered six hours after the first. After 14 consecutive days of use, researchers evaluated the effects of the eye drops and found that a significantly higher proportion of individuals in the treatment group experienced improved vision. In one test, they were able to read three or more additional lines on an eye chart.

In terms of safety, the results were similar to previous trials with once-daily dosing, with the main adverse reactions being headache and eye irritation. Allergan plans to present more trial details at upcoming medical conferences and use this data to support its supplemental New Drug Application.

"We are encouraged by the results of the VIRGO trial, which suggest that twice-daily use of Vuity may offer an additional treatment option for presbyopia patients, improving their near vision without compromising their distance vision," said Professor Christopher Lievens, the lead investigator of this clinical trial. He also noted that, with a similar safety profile, twice-daily use of Vuity is expected to provide greater flexibility for presbyopia patients.

References:

[1] Allergan, an AbbVie Company, Announces Positive Topline Phase 3 Results Evaluating Investigational Twice-Daily Administration of VUITY™ (pilocarpine HCI ophthalmic solution) 1.25% in Adults with Age-Related Blurry Near Vision (Presbyopia), Retrieved April 5, 2022, from https://www.prnewswire.com/news-releases/allergan-an-abbvie-company-announces-positive-topline-phase-3-results-evaluating-investigational-twice-daily-administration-of-vuity-pilocarpine-hci-ophthalmic-solution-1-25-in-adults-with-age-related-blurry-near-vision-pre-301517329.html

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