- June 26, 2020
Dubbed Durysta, the 10 mcg implant is designed to rest as a small polymer plug on the edge of the iris, underneath the cornea, to help regulate fluid pressure within the eye in people with open-angle glaucoma or ocular hypertension. In phase 3 clinical studies, the sustained-release prostaglandin analog lowered intraocular pressure by 30% over a three-month period. After three doses, more than 80% participants reported they did not need additional treatments, such as medicated eye drops, to help maintain their intraocular pressure for at least one (1) year.
“Today’s 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,” Allergan’s Chief R&D Officer, David Nicholson, said in a statement.
If left uncontrolled, high intraocular pressure can damage the optic nerve, leading to the progressive vision loss tied to glaucoma. Therapies can include laser procedures or minimally invasive incisions aimed at the drainage systems of the eye — but the most common, front-line treatment remains topical eye drops on a regular basis.
However, Allergan estimates that as many as 80% of patients are not using these medications as prescribed, or adhering to the daily schedule. The Big Pharma — which also markets bimatoprost as glaucoma eye drop Lumigan — describes Durysta as the first biodegradable, sustained-release, intracameral implant for this indication.
Going forward, Allergan said it is continuing five (5) ongoing phase 3 clinical studies of Durysta to net additional information to its FDA label, as well as to support approvals internationally. This includes examinations of the implant’s duration of effect, and comparisons to laser-based procedures.
REFERENCE: FierceBioTech; 05 MAR 2020; Conor Hale