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Novel ocular insert maintains lowered IOP in patients with open-angle glaucoma or ocular hypertension

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FORT LAUDERDALE, Fla. — A novel bimatoprost insert can provide IOP reduction for up to 13 consecutive months in patients with open-angle glaucoma or ocular hypertension, according to mid-term data of an open-label extension study presented here.

IOP was reduced 4 mm Hg to 5 mm Hg in patients included in the study, an extension of a phase 2 clinical trial that looked at efficacy and safety of the novel bimatoprost insert, Kuldev Singh, MD, told colleagues at the American Glaucoma Society meeting, where he delivered the presentation in place of James D. Brandt, MD. In the phase 2 study, IOP in the bimatoprost insert group decreased 4 mm Hg to 6 mm Hg in months 0 to 6.

Kuldev Singh

“The open-label extension is a safety study to satisfy an FDA requirement for [demonstrating] greater than 1 year of safety in these types of studies,” Singh said.

The device, a ring formulated with preservative-free bimatoprost, is inserted in the conjunctival cul-de-sac via an external approach and rests under the eyelids. The device is not bioabsorbable and needs to be replaced every 6 months.

Of 75 patients enrolled in the extension study, data at month 13 were available for 65 patients. Only one serious ocular adverse event occurred, decreased visual acuity, which was thought to be due to cataract and not to the bimatoprost insert, Singh said.

“One of the keys to drug delivery is retention,” Singh said, reporting that 97.3% of patients in the extension study at month 13 had primary retention of the insert, that is, from month 6 to month 13 — a better rate than in the phase 2 study.

“Part of this may mean that as people use the device longer, they become more comfortable in avoiding the things that cause the device to be dislodged,” he said.

The insert appears safe and well-tolerated with a high degree of retention and comfort, Singh said, “and when it is dislodged, patients are aware that it’s dislodged, which is another advantage.” – by Patricia Nale, ELS

Reference:

Singh K. Reduction in IOP from a sustained-release bimatoprost ocular insert: mid-term results of an open label extension study (OLE study). Presented at: American Glaucoma Society 26th annual meeting; March 3-6, 2016; Fort Lauderdale, Fla.

Disclosure: The study was funded by ForSight Vision5. Brandt reports he has received research funding and travel stipends from ForSight Vision5. Singh reports he serves as a scientific advisor to ForSight Vision5.