Twice-daily Vuity meets primary endpoint in phase 3 presbyopia trial
Click Here to Manage Email Alerts
Twice-daily Vuity for presbyopia met its primary efficacy endpoint in the phase 3 VIRGO trial, according to a press release from Allergan/AbbVie.
Vuity (pilocarpine HCl ophthalmic solution 1.25%) improved near vision without compromising distance vision at hour 9, 3 hours after the second drop, on day 14 of the study, the release said.
“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 R. Robinson, MD, vice president, global therapeutic area head, ophthalmology, AbbVie, said in the release. “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 trial comprised 230 participants between the ages of 40 and 55 years with presbyopia. A greater proportion of subjects treated with Vuity than placebo achieved three lines or more in mesopic high-contrast binocular distance corrected near visual acuity with no more than a five-letter loss in low-light corrected distance visual acuity at day 14, hour 9.
The safety profile was similar to what investigators observed in studies of once-daily Vuity.
Vuity was approved for once-daily use in October 2021. The VIRGO trial results will support a supplemental new drug application submission in the second quarter of 2022.
Read more about
Click Here to Manage Email Alerts