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    Bimatoprost sustained-release implants: Potential new pathway for glaucoma patients

    Take-home: The bimatoprost sustained-release implant (bimatoprost SR, Allergan) improves compliance for patients with problematic compliance with topical IOP-lowering glaucoma drugs and controlled the IOP for 6 months after injection.

    Austin, TX—The bimatoprost sustained-release implant (bimatoprost SR, Allergan) offers a major advantage for patients, namely, improved compliance for those with problematic compliance with topical IOP-lowering glaucoma drugs. Almost three quarters of study patients experienced IOP control over the first six months of the phase 1/2 safety and efficacy trial.

    The implant is a biodegradable device especially developed to make sure the drug gets to its target location in order to best control glaucoma. The implant, according to Thomas Walters, MD, is placed intracamerally in the eye using a prefilled, single-use applicator system that releases bimatoprost over an extended period.

    Phase 1/2 trial

    This is a prospective, 24-month, dose-ranging, controlled clinical trial in patients with open-angle glaucoma to evaluate the IOP-lowering effect and safety of bimatoprost sustained-release in patients with glaucoma. After a washout period, one eye (termed the study eye) of 75 patients was injected intracamerally with an implant containing one of four doses, i.e., 6, 10, 15, or 20 micrograms, of bimatoprost.

    The fellow eye was treated with topical bimatoprost 0.03% once daily. Retreatment was permitted with the implant containing the three lower drug doses (6, 10, or 15 micrograms) beginning at 16 weeks after the start of the study until month 12. Topical IOP rescue drugs also could be administered to either eye of the patients. The primary outcome measures were the changes in the IOP compared with baseline and the development of any adverse events.

    All study patients were older than 18 years and had open-angle glaucoma in the eye that received the implant. All had an IOP ranging from 22 to 36 mm Hg after the washout period.

    Patients were excluded if they had a history of narrow-angle or closed-angle glaucoma or had undergone a surgery to removed cataract in which a posterior capsular tear occurred. In addition, they also were excluded if the central endothelial cell count was less than 2,000 cells/mm2.

    The mean patient age was 63.1 years, and the patients were evenly divided by gender. The mean baseline IOP in the study eye was 25.2 mm Hg and that in the fellow eye was 24.5 mm Hg.

    “The IOP decreased significantly compared with baseline with all doses of the drug in the implant,” Dr. Walters reported.


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