Nov. 3, 2021
Allergan, an AbbVie company, announced that the U.S. Food and Drug Administration (FDA) has approved VUITY (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia.
VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. 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,” says Michael Severino, MD, vice-chairman and president, AbbVie. “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 FDA approval of VUITY exemplifies our continued pursuit of innovative new treatments that push the boundaries of what’s possible in eyecare.”
VUITY is a daily, prescription eye drop that 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. 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.
“As we age, the lenses of our eyes become less flexible, making it more difficult to focus on things up close. VUITY offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision,” says George O. Waring IV, MD, FACS, medical director, 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.”
The FDA 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 six 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.
Allergan presented new pooled analyses and post hoc results from the Phase 3 trials of AGN-190584 (pilocarpine HCl ophthalmic solution 1.25%) at Academy 2021, the annual meeting of the American Academy of Optometry.
Presentations included clinical results for near and intermediate vision, functional near vision, efficacy for post-LASIK patients, and the patient experience.
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Abstracts for Academy 2021 can be viewed on the Academy website HERE.
Posters are listed below:
• AGN-190584 Improves Intermediate Vision in Pooled Phase 3 GEMINI 1 and 2;
• Comparison of Participants with and without LASIK in Near Vision Improvement with AGN-190584 Treatment;
• Near Vision Line Improvement Stratified by Baseline Severity with AGN-190584 in Pooled Phase 3 GEMINI 1 and 2;
• Pooled Phase 3 GEMINI 1 and 2: AGN-190584 Improves Functional Near Vision;
• Interpreting Clinically Meaningful Near Vision Improvement in Presbyopia With AGN-190584 in the Gemini 1 Phase 3 Trial;
• GEMINI I and 2 Patient Experience with the Use of AGN-190584 (Pilocarpine 1.25%) for Presbyopia