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Single dose of bimatoprost ocular insert demonstrates IOP reduction in glaucoma, ocular hypertension

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LAS VEGAS — A single dose of a novel topical bimatoprost ocular insert demonstrated sustained IOP reduction in patients with glaucoma and ocular hypertension at 6 months, according to phase 2 study results presented here.

“Despite highly effective topical treatments, half of our patients stop using their drops by 1 year, and among those who do continue to use their drops, many of them have difficulty using them properly. ... There is a pressing need for sustained patient behavior independent of delivery of glaucoma medications to prevent blindness,” James D. Brandt, MD, said at the American Academy of Ophthalmology annual meeting.

James D. Brandt

Results of a phase 1 study of the insert presented earlier in the year suggested that it was “safe, well-tolerated and lowered IOP for up to 6 months,” Brandt said.

The randomized, double-masked controlled phase 2 study compared 64 patients dosed with the topical bimatoprost ocular insert and artificial tears with 66 patients dosed with a placebo insert and 0.5% timolol drops for a duration of 6 months.

At 2 weeks, the mean diurnal IOP was 23.8 mm Hg in the bimatoprost group and 24.1 mm Hg in the timolol group. At 6 months, mean diurnal IOP was 20.1 mm Hg in the bimatoprost group and 19 mm Hg in the timolol group.

There were no unanticipated adverse events observed in the study, he said.

“We encountered no cases of dislodging or that the subjects were unaware that the insert had been lost. During the washout phase, about 90% of subjects found the non-medicated inserts to be comfortable and elected to continue in the study, and importantly, if a subject experienced an insert-related discomfort, it was discovered in the first day or two of the study,” Brandt said.

Initiation of a phase 3 program for the bimatoprost ocular insert is anticipated in 2016, Brandt said. – by Nhu Te

Reference:

Brandt J. Six-month IOP reduction with a single dose of a novel topical bimatoprost ocular insert: A phase 2 randomized, double-masked, controlled study. Presented at: American Academy of Ophthalmology meeting. Nov. 17, 2015; Las Vegas.

Disclosure: Brandt reports he is a consultant for ForSight Vision5, Glaukos and Reichert Technologies; is an equity owner at Glaukos; and receives grant support from ForSight Vision5.