Bimatoprost ocular insert reduces IOP in glaucoma patients over 6 months
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NEW ORLEANS — Glaucoma patients implanted with a bimatoprost ocular insert showed a clinically relevant reduction in IOP over 6 months, according to a study presented here.
“[In patients with ocular hypertension], we found that lowering IOP by 20% will decrease the relevant risk of developing glaucoma by 60% among the subjects in our study, and if we achieve this sort of efficacy level, we can prevent many patients from diurnal loss and developing vision loss,” James D. Brandt, MD, said at the Ophthalmology Innovation Summit preceding the American Society of Cataract and Refractive Surgery meeting.
James D. Brandt
The phase 2 prospective, randomized, double-masked, active-controlled, parallel-arm study published in Ophthalmology included 130 adult patients with open-angle glaucoma or ocular hypertension. Patients were randomized to receive a bimatoprost ocular insert (ForSight Vision5) plus twice-daily artificial tears or a placebo insert plus twice-daily timolol 0.5% ophthalmic solution for 6 months.
Researchers obtained diurnal IOP measurements at 0 hours, 2 hours and 8 hours at baseline, 2 weeks, 6 weeks, 12 weeks, 4 months, 5 months and 6 months.
Over 6 months, mean reduction of IOP from baseline ranged from 3.2 mm Hg to 6.4 mm Hg in the bimatoprost group and from 4.2 mm Hg to 6.4 mm Hg in the timolol group.
Primary retention rate of the inserts was 93.1% at 12 weeks and 88.5% at 6 months.
There were no reported unexpected ocular adverse events.
“The FDA has provided clear phase 3 guidance, and the company is poised to start clinical trials soon. I’m excited not only by the bimatoprost ring, but by the opportunity to use the ring as a platform for other medications,” Brandt said. – by Nhu Te
Reference:
Brandt JD, et al. Ophthalmology innovation showcase. Presented at: Ophthalmology Innovation Summit; May 5, 2016; New Orleans.
Disclosure: Brandt reports he receives research and trial support from ForSight Vision5.