FDA Accepts New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension
Allergan announced that the U.S. FDA accepted their New Drug Application for Bimatoprost Sustained-Release (SR). The FDA is expected to take action on the New Drug Application by the end of the first half of 2020.
In two Phase 3 ARTEMIS studies, Bimatoprost SR reduced intraocular pressure (IOP) by 30% over a 12-week primary efficacy period. The studies included 1,122 participants with open-angle glaucoma or ocular hypertension and evaluated the efficacy and safety of Bimatoprost SR versus timolol. After three treatments with Bimatoprost SR, more than 80% of patients remained treatment-free and did not need additional treatment to maintain IOP control for at least 12 months. Bimatoprost SR was well tolerated in most patients.
According to Robert Weinreb, MD, Chairman & Distinguished Professor of Ophthalmology and Director of the Shiley Eye Institute, San Diego, Bimatoprost SR “has the potential to be the first sustained-release option that could significantly shift the paradigm for treating glaucoma.”
You can read more here.