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The primary endpoint of improving near vision without compromising distance vision at Day 14, Hour 9 was met.
Today, new data from the phase 3 VIRGO trial evaluating the safety and efficacy of pilocarpine HCI ophthalmic solution 1.25% (VUITY) in adults with age-related blurry near vision (presbyopia) reported meeting its primary efficacy endpoint.
The ophthalmic solution improved near vision without comprising distance vision at Hour 9, considered 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," said Christopher Lievens, O.D., clinical trial investigator and professor, Southern College of Optometry in a 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."
More data will be presented at future medical congresses and serve as the basis for a supplemental New Drug Application submission to the US Food and Drug Administration (FDA) for an optional twice-daily administration, expected in Q2 of 2022.
Within the VIRGO trial, a total of 230 participants aged 40 - 55 years old with presbyopia were randomized 1:1 to placebo or pilocarpine HCI ophthalmic solution 1.25%, receiving 2 drops in each eye per day for 14 days. The second drop was performed 6 hours after the first drop.
It met its primary endpoint with a statistically significant proportion of individuals treated with the ophthalmic solution twice daily gained 3 lines or more in mesopic, 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 versus placebo.
Additionally, the safety profile was observed as similar to those with once-daily administration, with the most common adverse events occurring at a frequency of >5% were headache and eye irritation. Safety and efficacy of twice-daily use has 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," added 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."
The agent was originally approved by the FDA in October 2021 for once-daily use and is the first and only eye drop to treat age-related blurry near vision in adults.