Treats presbyopia. NDA 218585, held by Lenz Therap. Aceclidine Hydrochloride.
As of Nov 13, 2026, NDA 218585 (Vizz), held by Lenz Therap, was first approved by FDA on Jul 31, 2025, with 0 approved supplements and 0 published complete response letters.
VIZZ is indicated for the treatment of presbyopia in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| VizzEQ 1.44% BASE · solution/drops;ophthalmic | Aceclidine Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
