Reduces elevated intraocular pressure (IOP). NDA 215092, held by Ocuvex Therap. Omidenepag Isopropyl.
As of Nov 15, 2026, NDA 215092 (Omlonti), held by Ocuvex Therap, was first approved by FDA on Sep 22, 2022, with 1 approved supplement and 1 published complete response letter.
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 2022 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Nov 9, 2021 | Omlonti (omidenepag isopropyl ophthalmic solution) | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omlonti0.002% · solution;ophthalmic | Omidenepag Isopropyl | RxReference drug |
| Sep 22, 2022 | Original applicationNew molecular entity · Standard review | Approved | |
| Sep 22, 2022 | Supplement 1 | Approved | None posted |
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
