Positive topline results were announced from a phase 3 study evaluating the twice daily administration of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia.
The multicenter, double-masked, randomized, vehicle-controlled parallel-group VIRGO study (ClinicalTrials.gov Identifier: NCT04983589) evaluated the efficacy and safety of Vuity in adults aged 40 to 55 years of age with presbyopia (N=230). Patients were randomly assigned 1:1 to receive Vuity or vehicle, 2 drops in each eye daily for 14 days, with the second drop 6 hours after the first drop.
Findings showed that the study met the primary endpoint. A statistically significant proportion of patients treated with Vuity twice daily gained 3 lines 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, hour 9 (3 hours after the second drop) compared with those treated with vehicle.
The safety profile of Vuity twice daily was consistent with that seen in previous studies for Vuity administered once daily. The most common adverse reactions (incidence greater than 5%) were headache and eye irritation.
“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, OD, 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 October 2021, the Food and Drug Administration (FDA) approved Vuity for once daily administration to treat presbyopia in adults. The approval was based on data from the phase 3 GEMINI 1 (ClinicalTrials.gov Identifier: NCT03804268) and GEMINI 2 (ClinicalTrials.gov Identifier: NCT03857542) studies.
The Company expects to submit a supplemental New Drug Application with data from the VIRGO study to the FDA in the second quarter of 2022.
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). News release. AbbVie. Accessed April 5, 2022. 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