Allergan’s Vuity for Presbyopia Meets Primary Efficacy Endpoints
The eye drop treats age-related blurry near vision in adults and is FDA-approved for once-daily administration.
The phase 3 trial, VIRGO, which evaluated the efficacy and safety of the investigational, twice-a-day administration of pilocarpine HCl ophthalmic solution (Vuity) 1.25% in adults with presbyopia, met its primary efficacy endpoint, AbbVie subsidiary Allergan said in a statement.
The primary endpoint was improving near vision without compromising distance vision at hour 9 and 3 hours after the second drop, on day 14.
“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,” Christopher Lievens, OD, a clinical trial investigator and professor at Southern College of Optometry, said in the statement. “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.”.
Additional results 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 FDA in the second quarter of 2022.
In the VIRGO phase 3 trial, investigators included a total of 230 individuals, aged 40 to 55 years, with presbyopia, a common and progressive eye condition that reduced the eye’s ability to focus on near objects and is considered age-related blurry vision.
Individuals were randomized, 1-to-1, to receive either the placebo or Vuity 2 drops in each eye per day for 14 days, with the second drop 6 hours after the first drop.
The study met its primary endpoint, which showed a statistically significant proportion of individuals treated with Vuity twice a day and gained the ability to read 3 additional lines on a near-vision chart or more in mesopic, high contrast, binocular distance-corrected near visual acuity, with no more than 5-letter loss in low-light corrected distance visual acuity at day 14 by hour 9.
“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,” Michael Robinson, MD, vice president and global therapeutic area head of ophthalmology at AbbVie, said in the statement. “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.”
The safety profile was similar to those in previous studies with once-daily administration of Vuity. The most common adverse events occurred at a frequency of less than 5% and included eye irritation and redness and headaches.
The FDA has not approved the twice-daily use of Vuity, nor has it evaluated the medication’s efficacy and safety.
If more than 1 topical eye medication is used, the medications must be administered at least 5 minutes apart, investigators said.
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). AbbVie. News release. April 5, 2022. Accessed April 6, 2022. https://news.abbvie.com/article_display.cfm?article_id=12425#:~:text=NORTH%20CHICAGO%2C%20Ill.%2C%20April,with%20presbyopia%20met%20its%20primary