Allergan announced Thursday that the FDA approved its filing for Durysta (bimatoprost), making the ophthalmic drug-delivery system the first intracameral, sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The clearance "provides a much-needed option for patients challenged with topical drops or needing alternative options," said the company's R&D chief David Nicholson.
According to Allergan, the decision is based on results from the two 20-month Phase III ARTEMIS studies comparing Durysta versus twice-daily topical timolol drops in 1122 patients with open-angle glaucoma or ocular hypertension. The drugmaker said that in both trials, Durysta reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period, meeting criteria for non-inferiority to the comparator product. Further, the company reported that after three treatments with Durysta, over 80% of patients remained treatment-free and did not need additional therapy to maintain IOP control for at least 12 months.
Nicholson indicated that Allergan has five ongoing Phase III studies with Durysta to support "further potential FDA label enhancement and rest of the world approvals." The company noted that Durysta is preloaded into a single-use applicator to facilitate the administration of the biodegradable implant directly into the anterior chamber of the eye.
Allergan currently markets bimatoprost in the US as an ophthalmic solution under the name Lumigan to reduce IOL in patients with ocular hypertension and glaucoma. The prostaglandin analogue is also sold under the brand name Latisse to treat hypotrichosis of the eyelashes.
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