March 6, 2020 – Allergan announced today the approval of DURYSTA™ (bimatoprost implant), the first biodegradable sustained-release implant for the treatment of open-angle glaucoma.
The implant works by delivering 10 mcg of bimatoprost directly into the anterior chamber of the eye, although its use is limited to a single implant per eye. The FDA approval was based on the results of the two phase 3 ARTEMIS studies of Durysta, which evaluated the implant over 20 months, including an 8-month extended follow up.
“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, Distinguished Professor of Ophthalmology and Vice Chair for Technology, Director Clinical Research Unit, Department of Ophthalmology, Duke University. “The ARTEMIS trials demonstrated that DURYSTA™ lowered IOP in patients by approximately 30 percent and demonstrated a duration of effect through the 12-week primary efficacy period. As the first FDA-approved intracameral, biodegradable sustained-release implant providing continuous drug delivery, DURYSTA™ has the potential to significantly shift the paradigm for treating glaucoma.”
“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,” said David Nicholson, Chief Research and Development Officer, Allergan.”
Source: Allergan Press Release
First posted on March 6, 2020; Reviewed on May 12, 2022