Omidenepag Isopropyl

Reduces elevated intraocular pressure (IOP). Sold as Omlonti. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Omidenepag Isopropyl (sold as Omlonti), first approved Sep 22, 2022, with 0 new uses approved and 1 published complete response letter.

First approved: Sep 22, 2022
Applications: 1
New uses approved: 0
Complete response letters: 1
First approved in Japan: Sep 21, 2018

Approvals in Japan (PMDA)

First approved in Japan 48 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Eybelis, new ingredientA drug with a new active ingredient indicated for the treatment of glaucoma and ocular hypertension. · Santen Pharmaceutical Co., Ltd. · Sep 21, 2018

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Sep 22, 2022	OmlontiNDA 215092 · New molecular entity	Ocuvex Therap	1	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Nov 9, 2021	Omlonti (omidenepag isopropyl ophthalmic solution)	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA