The FDA has approved Allergan’s New Drug Application for Durysta, a prostaglandin analog 10-μg bimatoprost sustained-release implant for intracameral administration, formerly known as Bimatoprost SR. With this approval, Durysta becomes the first intracameral, biodegradable sustained-release implant indicated to reduce IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
The bimatoprost implant had demonstrated promise from the beginning of its clinical study. In a 75-patient early-stage phase 1/2 clinical trial, 28% of patients went 24 months with a single implant without retreatment. The phenomenon was seen among all dose cohorts and was not dose dependent, principal investigator Ike Ahmed, MD, from Prism Eye Institute in Toronto, told Glaucoma Physician last year.
“FDA approval marks a breakthrough milestone for the glaucoma community and provides a much-needed option for patients challenged with topical drops or needing alternative options," said David Nicholson, Chief Research and Development Officer of Allergan, in a news release. Earlier, Nicholson had noted that the data in the two pivotal phase 3 trials, had been “sustained, predictable, and potentially sight-saving.”
The approval is based on results from the two 20-month phase 3 ARTEMIS studies (including 8-month extended follow-up) evaluating 1,122 subjects on the efficacy and safety of Durysta vs twice-daily topical timolol drops, an FDA-accepted comparator for registrational clinical trials, in patients with OAG or OHT.
In the ARTEMIS studies, Durysta reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period, meeting the predefined criteria for noninferiority to the study comparator timolol. The device, implanted intracamerally at 4-month intervals for 1 year in an office-based procedure to continuously deliver bimatoprost, proved to have about the same IOP-lowering effects as timolol administered as an eye drop twice a day. In addition, Durysta 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 implant, 80% of trial participants were able to go an additional 12 months without 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 5 ongoing phase 3 studies with Durysta to support further potential FDA label enhancement and international approvals.