A 19-month, open-label study of a novel bimatoprost, sustained-release ocular insert shows good safety and efficacy. The insert is polymer ring that sits atop the eye in the conjunctival fornix. Phase III trials are expected to begin in 2017.
“There will clearly be a number of platforms for sustained release delivery of ocular drugs reaching the market over the next five to 10 years,” said James Brandt, MD, professor of ophthalmology and director, glaucoma service, University of California Davis, Sacramento, CA. “This platform is noninvasive and is ideally suited for the patient who has early glaucoma and you do not want to put at any additional risk.”
Dr. Brandt, who was lead author of the study, presented the mid-term results of an extension study of the topical ring (Bimatoprost Ring, ForSight Vision5).
Researchers extended the original 6-month randomized controlled trial for an additional 13 months as an open-label study.
The device is an inert polymer ring which elutes an effective daily dose of about 7 mcg of bimatoprost at 6 months. The ring is not bioabsorbable and is designed to be replaced by a clinician every 6 months. The open-label extension trial provided for 3 successive replacements of the device.
Early glaucoma patients
“The vast majority of people being treated with eye drops and other methods to lower IOP have very mild and early glaucoma,” Dr. Brandt explained. “These are the patients in whom you generally do not want to be injecting or implanting devices into the eye.”
In patients with early glaucoma or early hypertension, safety must be the priority, he said.
"The more invasive platforms look potentially effective, but with the potential of higher risk of complications to the patient,” he added. "This platform is essentially noninvasive. [It is] a flexible ring which sits on the eye and can be removed at any time.”
The ring is manufactured in multiple sizes. The flexible device is inserted beneath the upper lid and moved into the interior cul-de-sack with a scleral depressor or a cotton swab. The insert seats itself in the fornix with one or two blinks. Patients can feel the insert in place for a few days, but nearly all reported the device is comfortable or not bothersome.