■ In a 594-patient phase 3 clinical trial, an investigational, sustained-release version of Allergan’s Lumigan (Bimatoprost SR), formatted as a biodegradable intracameral implant, demonstrated a major treatment benefit in patients with open-angle glaucoma or ocular hypertension. Patients receiving Bimatoprost SR experienced 30% lower IOP over the 12-week primary efficacy period when compared to patients receiving timolol eye drops, meeting the noninferiority endpoint while being well tolerated by most patients. Bimatoprost SR is designed to lower IOP for 4 months, freeing patients from daily eye drop regimens.
“Bimatoprost SR has the potential to be the first sustained-release option of a drop-free therapy for patients who are suffering from glaucoma. This is a real potential paradigm shift,” said Randy Craven, MD, associate professor at Johns Hopkins University School of Medicine, in a news release. Additional safety data from the study and topline results from a second phase 3 clinical trial will be reported in early 2019, with the possibility of a United States marketing application to be filed in the second half of 2019.