Allergan announces positive topline Phase 3 results for presbyopia therapeutic

Allergan, an AbbVie company, today announced that the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of pilocarpine HCl ophthalmic solution 1.25%(Vuity) 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.

According to the company 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 US Food and Drug Administration (FDA) in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, pilocarpine HCl ophthalmic solution 1.25% 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,” Christopher Lievens, OD, clinical trial investigator and professor, Southern College of Optometry, said 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.”

In the VIRGO Phase 3 trial, a total of 230 participants aged 40 to 55 years old with presbyopia were randomly assigned in a 1-to-1 ratio of vehicle (placebo) to pilocarpine HCl ophthalmic solution 1.25%, 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 pilocarpine HCl ophthalmic solution 1.25%; the most common adverse events occurring at a frequency of > 5% were headache and eye irritation. The twice-daily use of pilocarpine HCl ophthalmic solution 1.25% 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, MD, 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."