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Second Phase 3 Trial Validates Efficacy of Bimatoprost SR

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A second large-scale phase 3 clinical trial called ARTEMIS 3 has confirmed the efficacy and safety of the Bimatoprost SR sustained-release implant (Allergan) for the treatment of patients with open-angle glaucoma and ocular hypertension. The 2 phase 3 trials had an identical study design. The results were presented by Felipe A. Medeiros, MD, at the recent American Glaucoma Society meeting in Washington, DC. 

The biodegradable device, implanted intracamerally at 4-month intervals for 1 year in an office-based procedure to continuously deliver the prostaglandin analogue bimatoprost, proved to have about the same IOP-lowering effects as the comparator timolol administered as an eye drop twice a day. In addition, Bimatoprost SR showed evidence of being able to slow glaucoma progression, as evidenced on visual fields.

In the 742-patient ARTEMIS 3 trial, participants began the trial with an average baseline IOP of 24 mmHg and had IOP maintained at 16-17 mmHg. After completing a year with the Bimatoprost SR implant, 80% of trial participants were able to go an additional 12 months without the need for retreatment.

Side effects were generally mild. Endothelial cell loss averaged 6% over 20 months, and no significant changes in corneal thickness were reported. The ARTEMIS 3 data did not include patients who required rescue medication.

Allergan has filed an NDA with the FDA for approval for this delivery system for glaucoma medications and expects a decision within the next several months. If approved, Bimatoprost SR would eliminate problems with adherence that are prevalent with the traditional eye drop format for delivering glaucoma medications. It would also mean that doctors and patients would have to adjust to a more invasive method of delivery.

Another sustained-release format for delivering glaucoma medications, the Glaukos iDose, has now advanced into a phase 3 clinical trial.