Positive Phase I/II interim data of Bimatoprost sustained-release implant for IOP therapy in glaucoma

Bimatoprost SR is a biodegradable, intracameral implant providing slow release of bimatoprost and is a differentiated approach to treat glaucoma beyond conventional daily eye drop treatments because it is a non-daily treatment administered by a physician.

"We are encouraged by these interim results, and Phase III trials are currently underway," said David Nicholson, Executive Vice President and President, Global Brands Research & Development, Allergan.

"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."

In the Phase I/II dose-ranging, paired-eye controlled clinical trial, a total of 75 patients received the implant via an intracameral injection in one eye, and daily topical bimatoprost 0.03% in the other eye. The dose strengths of Bimatoprost SR were 6, 10, 15, or 20 micrograms. All dose strengths of Bimatoprost SR were comparable with topical bimatoprost 0.03% in overall IOP reduction through week 16. The overall mean IOP reduction from baseline at 4 months in study eyes that received a single Bimatoprost SR implant ranged from 7.2 to 9.5 mm Hg while pooled fellow eyes receiving once-daily treatment with topical bimatoprost 0.03% had a reduction of 8.4 mm Hg. At month 6, 71% (n=53) of study eyes still had not received topical IOP-lowering rescue or a second injection of Bimatoprost SR.

"Patients having challenges in taking their daily eye drops is one of the greatest challenges we face as eye care physicians," said Richard Lewis, clinical trial investigator, former director of glaucoma at the University of California, Davis, and ophthalmologist at Sacramento Eye Consultants. "The results seen to date indicate that Bimatoprost SR may offer patients a non-daily treatment option that is administered by a physician."