FDA accepts application for Bimatoprost Sustained-Release
The FDA has accepted a new drug application for Bimatoprost Sustained-Release to reduce IOP in primary open-angle glaucoma or ocular hypertension, Allergan announced.
Data supporting the application from the two phase 3 ARTEMIS trials showed Bimatoprost SR reduced IOP by 30% over 12 weeks, according to a press release. In addition, more than 80% of patients were treatment-free after three Bimatoprost SR treatments and did not require further treatment for IOP control for at least 12 months.
“With decades of experience researching and introducing innovative eye care treatments, we understand the importance of developing new and potentially sight-saving treatments for patients with glaucoma,” David Nicholson, Allergan chief research and development officer, said in the release.
FDA action on the NDA is expected by the end of the first half of 2020.