Allergan announces favorable safety, efficacy profile for bimatoprost sustained-release in phase 1/2 trial

Allergan announced positive safety and efficacy results from an interim phase 1/2 clinical trial of a single dose of bimatoprost sustained-release to treat glaucoma, according to a press release.

In the 24-month trial, a single dose of non-daily bimatoprost sustained-release (SR), a biodegradable intracameral implant that provides a slow release of bimatoprost, lowered IOP in 92% of patients at 4 months and 71% of patients at 6 months with a favorable efficacy and safety profile, the release said.

“We are encouraged by these interim results, and phase 3 trials are currently underway,” David Nicholson, PhD, executive vice president and president of Global Brands Research and Development for Allergan, said in the release. “Bimatoprost SR has the potential to be a novel approach to treat glaucoma beyond conventional eye drop treatments and illustrates our commitment to bringing innovative solutions for physicians to help them meet the needs of their patients.”

Seventy-five patients received the implant through an intracameral injection in one eye and daily topical bimatoprost 0.03% in the other eye. At 4 months, mean IOP reduction ranged from 7.2 mm Hg to 9.5 mm Hg in the study eyes and was 8.4 mm Hg in the pooled fellow eyes.

At 6 months, 71% of implanted eyes did not need topical IOP-lowering rescue or a second injection of bimatoprost SR. There were no serious ocular adverse events, the release said.