Allergan’s Bimatoprost lowers intraocular pressure in glaucoma patients (Phase I/II trial)

A single dose of Bimatoprost Sustained-Release (SR) lowered intraocular pressure (IOP) in 92 percent (n= 69) of glaucoma patients at 4 months and 71 percent (n=53) at 6 months while demonstrating a favorable efficacy and safety profile. This was shown in Allergan’s 6-month interim results from a 24-month Phase I/II clinical trial of 75 patients.

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.

David Nicholson, Ph.D., Executive Vice President and President, Global Brands Research & Development, Allergan said that the results were encouraging, and that Phase III trials are currently underway.

“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,” said Nicholson.

Allergan said in an announcement on Monday that 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.

According to Allergan, 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 company said.

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 percent (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, M.D., 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.”

About the Trial

Ongoing Phase I/II, prospective, 24-month, dose-ranging, paired-eye, controlled clinical trial. The objective of the trial is to evaluate the safety and efficacy of Bimatoprost SR in lowering IOP in patients with open angle glaucoma and ocular hypertension. Rescue with topical IOP-lowering medication was required by only 4 (5.3 percent) study eyes up to week 12 and 6 (8 percent) study eyes up to week 16. After 12 weeks, Bimatoprost SR continued to provide statistically significant (P=.001) IOP lowering through 6 months of follow-up.