Allergan, an AbbVie company, has received FDA approval for its twice-daily dosing option of Vuity (pilocarpine hydrochloride ophthalmic solution) 1.25% in adults with presbyopia.
Tell me about Vuity.
Vuity was approved by the FDA in October 2021 as the first and only once-daily prescription eye drop for presbyopia.
The drop is delivered via a proprietary technology that can quickly adjust to the tear film’s natural PH, with improved near vision typically noticed within 30 minutes after administration and lasting up to 6 hours.
How about this new version?
The twice-daily drop (with one additional drop in each eye) can be administered 3 to 6 hours following the first dose, extending its duration of effect to up to 9 hours.
Any clinical data?
Yes! The multi-center, double-masked, randomized, vehicle-controlled phase 3 VIRGO trial (NCT04983589) enrolled 230 patients (ages 40 to 55) diagnosed with presbyopia.
Participants were randomized to receive Vuity (n = 114) or a placebo (n = 116) as one drop in each eye, twice daily. Each dose was administered 6 hours apart for 14 days.
Findings?
The study met its primary endpoint, which included the proportion of patients gaining 3 lines or more in mesopic, high contrast, binocular distance-corrected near visual acuity (DCNVA) with no more than a 5-letter loss in low light corrected distance visual acuity (CDVA) at Day 14 and Hour 9 versus the placebo: 35.1% vs 7.8%, P < 0.0001.
Any adverse reactions?
The most common adverse reactions reported—headache and eye irritation—occured in >5% of patients.
Ocular adverse reactions—visual impairment, eye pain, blurred vision, and vitreous floaters—were reported in 1 to 5% of patients.
What’s next?
At this time, the FDA has approved the use of a 5 mL fill size bottle; however, the 2.5 mL bottle is currently the only fill size available in the market.
Stay tuned for updates on the 5 mL availability and pricing in the near future.