Allergan’s bimatoprost implant (Durysta) is now the first approved intracameral, sustained-release therapy for lowering IOP in patients with open-angle glaucoma or ocular hypertension.
"Millions of people are living with glaucoma, one of the leading causes of vision loss; however, new treatment options are needed to help doctors and patients better manage this disease," said Felipe Medeiros, MD, PhD, of Duke University, adding that Allergan’s implant could “significantly shift the paradigm for treating glaucoma.”
Delivered through an intracameral injection, the system includes a biodegradable implant containing 10 mcg bimatoprost that is preloaded in a single-use applicator. The implant is contraindicated in patients with ocular or periocular infections, corneal endothelial cell dystrophy, prior corneal or endothelial cell transplants and absent or ruptured posterior lens.
The FDA clearance was based on a pair of phase 3 trials in which the bimatoprost implant proved noninferior to twice-daily timolol drops, reducing IOP by approximately 30% from baseline. Among 1,122 study subjects, more than 80% remained treatment-free and did not require additional treatment for at least a year.
Conjunctival hyperemia was observed in 27% of patients. Another 5% to 10% of patients reported foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, irritation, IOP increase, corneal endothelial cell loss, blurred vision, iritis and headache. Complete prescribing and administration information is available online.
The company currently has 5 more ongoing phase 3 studies to support further possible label expansion and approvals around the world.