The US Food and Drug Administration (FDA) approved Lenz Therapeutics’ VIZZ™ (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop, for the treatment of presbyopia.
The approval was based on results from 3 randomized, controlled, double-masked, phase 3 studies (CLARITY 1, CLARITY 2, CLARITY 3). The first 2 studies evaluated the safety and efficacy of VIZZ in 466 patients who received a daily dose for 42 days. The third trial evaluated long-term safety over a 6-month period of once-daily dosing in 217 participants.
In CLARITY 1 and CLARITY 2, VIZZ improved near vision within 30 minutes and lasted up to 10 hours. The most commonly reported adverse events were installation site irritation, dim vision, and headache. Most adverse events were mild, transient, and self-resolving.
Samples of the once-daily eye drop are anticipated to become available in October.
Source: Press release
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