VUITY™ (pilocarpine HCI ophthalmic solution) 1.25% in Adults with Age-Related Blurry Near Vision (Presbyopia)

  • VUITY is the first and only eye drop to treat presbyopia, or age-related blurry near vision, in adults and is FDA-approved for once-daily administration
  • In the VIRGO trial evaluating twice-daily administration of VUITY, the primary endpoint of improving near vision without compromising distance vision at Day 14, Hour 9 was met
  • Data from the VIRGO trial will be presented at upcoming medical congresses and serve as the basis for a supplemental U.S. New Drug Application submission in the second quarter of 2022

Allergan, an AbbVie (NYSE: ABBV) company, today announced that the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia met its primary efficacy endpoint, improving near vision without compromising distance vision at Hour 9 (3 hours after the second drop) on Day 14. Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, VUITY is the first and only eye drop to treat age-related blurry near vision in adults.

“We are encouraged by the results from the VIRGO trial, which suggest that administering VUITY twice daily may provide an additional dosing option for people with presbyopia to improve their near vision without compromising their distance vision,” said Christopher Lievens, O.D., clinical trial investigator and professor, Southern College of Optometry. “With similar safety results compared to the previous studies evaluating once-daily administration, VUITY administered twice daily may offer more flexibility in how blurry near vision is managed.”

In the VIRGO Phase 3 trial, a total of 230 participants aged 40 to 55 years old with presbyopia were randomized in a one-to-one ratio of vehicle (placebo) to VUITY, receiving two drops in each eye per day for 14 days, with the second drop at Hour 6 (6 hours after the first drop). The study met its primary endpoint, showing a statistically significant proportion of participants treated with VUITY twice daily gained three lines (the ability to read three additional lines on a near vision chart) or more in mesopic (low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) with no more than 5-letter loss in low light Corrected Distance Visual Acuity (CDVA) at Day 14, Hour 9 (3 hours after the second drop) versus the vehicle (placebo).                    

The safety profile was similar to that observed in studies with once-daily administration of VUITY; the most common adverse events occurring at a frequency of >5% were headache and eye irritation. The twice-daily use of VUITY is not approved and its safety and efficacy have not been evaluated by the FDA.

“We know that many people with age-related blurry near vision are interested in the potential use of VUITY beyond once-daily administration to help manage their condition,” said Michael R. Robinson, M.D., vice president, global therapeutic area head, ophthalmology, AbbVie. “The results of the VIRGO trial showcase our continued effort to innovate for patients with age-related blurry near vision and commitment to expanding our leading portfolio of treatments for eye care providers and patients.”About Presbyopia

An estimated 128 million people in the U.S. experience presbyopia or age-related blurry near vision, 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).About VUITY

VUITY is an optimized formulation of pilocarpine, an established eye care 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. This was studied in simulated tear film, and the clinical significance is unknown. VUITY uses the eye’s own ability to reduce pupil size and improves near and intermediate vision without compromising distance vision.

About Allergan Eye Care

As a leader in eye care, Allergan has discovered, developed, and delivered some of the most innovative products in the industry for more than 70 years. Allergan has launched over 125 eye care products and invested billions of dollars in treatments for the most prevalent eye conditions including glaucoma, ocular surface disease, and retinal diseases such as diabetic macular edema and retinal vein occlusion.About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

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