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Single bimatoprost implant controls IOP at 2 years in some patients
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NEW ORLEANS — All doses and strengths of Allergan’s bimatoprost sustained release implant demonstrated efficacy in patients with open-angle glaucoma, E. Randy Craven, MD, said at the American Academy of Ophthalmology meeting.
Craven gave 24-month results of the phase 1/2 clinical trial of Bimatoprost SR, which was undertaken to evaluate the safety and effectiveness of the single use treatment in patients with ocular hypertension or open angle glaucoma. Patients were included in the study if they had responded to prostaglandins in the past, and if, after washout, IOP was between 22 mm Hg and 36 mm Hg, he said.
“The initial response, the drop in IOP, was fairly significant for all different doses,” Craven said. IOP was still controlled at 6 months in 60% of patients.
The primary endpoint was change in IOP from baseline as measured at different time points throughout the 24-month study. Four doses were administered on day 1— 6 µg, 10 µg, 15 µg or 20 µg.
“[A]t 2 years out, 24% of patients still had pressure control in the 10 µg and 15 µg doses,” he said.
“So, a single implant controlled the IOP in 24% of the patients at 24 months,” Craven said. “All doses and strengths of bimatoprost SR did demonstrate efficacy, and the implant that seemed to provide the most reasonable control for the period of time that we’re trying to evaluate, 4 to 6 months, again is the 10 µg and 15 µg doses. It seemed to be well tolerated, and phase 3 studies are now ongoing.” – by Patricia Nale, ELS
Reference:
Craven ER. 24-Month phase 1/2 clinical trial of bimatoprost sustained release implant (Bimatoprost SR) in glaucoma patients. Presented at American Academy of Ophthalmology annual meeting; Nov. 11-14, 2017; New Orleans.
Disclosure: Craven reports he is a consultant for Allergan and Novartis.