> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts Allergan’s Bimatoprost SR NDA
- URL: https://www.fdaweb.com/fda-accepts-allergans-bimatoprost-sr-nda/
- Published: 2019-07-18T12:00:00.000Z
- Updated: 2026-09-15T01:38:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144560

FDA has accepted Allergan’s NDA for Bimatoprost sustained-release for use in patients with open-angle glaucoma or ocular hypertension. The company [says](https://www.prnewswire.com/news-releases/us-fda-accepts-allergans-new-drug-application-for-bimatoprost-sustained-release-in-patients-with-open-angle-glaucoma-or-ocular-hypertension-300886238.html?ref=fdaweb.com) that if Bimatoprost SR is approved, it would be the first-in-class sustained-release, biodegradable implant for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The agency is expected to act on the NDA by mid-2020.

The company reports that in two Phase 3 ARTEMIS studies, Bimatoprost SR reduced intraocular pressure by 30% over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator.