Allergan’s Durysta Implant Approved to Treat Glaucoma

 

The U.S. Food and Drug Administration (FDA) approved Allergan’s Durysta (bimatoprost implant) 10 mcg for intracameral administration to treat open-angle glaucoma (OAG) or ocular hypertension (OHT).

Glaucoma is a progressive disease of the eye that can lead to irreversible vision loss and blindness. It is marked by increased levels of pressure in the eye, or ocular hypertension. The most common treatment is prostaglandin eye drops, with other treatments including laser trabeculoplasty, minimally invasive surgery and incisional surgery. Surprisingly, up to 80% of patients using the eye drops do not use it as prescribed.

Durysta is a prostaglandin analog delivery system for a single injection into the eye of a biodegradable implant that contains 10 mcg of bimatoprost.

“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 for Allergan. “At Allergan, our mission is to contribute meaningful strategies that help preserve people’s vision, while ensuring that therapies are mindful of the realities of administration and compliance. As a commitment to the ongoing development of this innovation, Allergan has five ongoing Phase III studies with Durysta to support further potential FDA label enhancement and rest of the world approvals.”

The approval is built on data from two 20-month Phase III ARTEMIS trials that evaluated 1,122 patients with Durysta compared to twice-daily topical timolol drops. In the trials, Durysta decreased IOP by about 30% over baseline over the 12-week primary efficacy period.

“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, Distinguished Professor of Ophthalmology and vice-chair for Technology, director Clinical Research Unit, Department of Ophthalmology at Duke University.

Earlier this week, Allergan and Editas Medicine treated the first patient in the BRILLIANCE clinical trial of AGN-151587 at Oregon Health & Science University (OHSU) Casey Eye Institute. The therapy is being tested for treatment of Leber congenital amaurosis 10 (LCA10), an inherited type of blindness caused by mutations in the centrosomal protein 290 (CEP290) gene.

“This dosing is a truly historic event—for science, for medicine, and most importantly for people living with this eye disease,” said Cynthia Collins, president and chief executive officer of Editas.

In this new clinical trial, physicians at the Casey Eye Institute injected microscopic droplets that carried a hollowed-out virus engineered to deliver the genetic instructions to manufacture the CRISPR gene-edits. This is a variation of gene therapy, where a preferable gene is delivered via a harmless virus.

“The first patient dosed in the BRILLIANCE clinical trial marks a significant milestone toward delivering on the promise and potential of CRISPR medicines to durably treat devastating diseases such as LCA10. We look forward to sharing future updates form this clinical trial and our ocular program,” Collins added.

The BRILLIANCE Phase I/II clinical trial will study the safety, tolerability, and efficacy of AGN-151587 in about 18 patients with LCA10. They expect to have up to five cohorts of patients across three dose levels. Both pediatric patients age three to 17 years, and adults, are eligible for the trial. The patients will be given a single dose of AGN-151587 by way of a subretinal injection in one eye.