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FDA accepts DURYSTA ™ (bimatoprost implant) New Drug Application

The DURYSTA eye implant has actually been accepted by the FDA to minimize intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT).

The US FDA (FDA) have approved New Drug Application (NDA) for DURYSTA ™ (bimatoprost implant), the first intracameral, constant dispense implant shown to reduce IOP in people with OAG or OHT.

The authorization is based on results from two Phase III ARTEMIS trials, comparing DURYSTA to timolol eye drops in people with OAG or OHT. The research studies examined 1,122 subjects over a program of 20 months and DURYSTA was shown to decrease IOP by 30 percent over the 12-week efficacy period, verifying it was non-inferior to timolol.
DURYSTA is an ocular drug delivery system that is implanted right into the anterior chamber of the eye. It supplies sustained-release of bimatoprost, a prostaglandin analogue which can reduce IOP. DURYSTA can only be implanted once into each eye and can create adverse corneal effects, according to the manufacturer.

“Today’s FDA approval notes a breakthrough milestone for the glaucoma community as well as offers a much-needed option for patients tested with topical drops or requiring alternate choices,” stated the Chief R & D Officer at the manufacturer. “Our goal is to contribute meaningful approaches that help preserve people’s vision, while ensuring that treatments are mindful of the realities of administration and also compliance. As a dedication to the continuous development of this innovation, we have 5 ongoing Stage III research studies with DURYSTA ™ to support more potential FDA label enhancement and rest of the world approvals.”

“Many people are dealing with glaucoma, one of the leading causes of vision loss; nonetheless, new treatment alternatives are required to assist physicians and also patients much better handle this disease,” stated an ophthalmologist. “As the initial FDA-approved intracameral, biodegradable sustained-release implant giving continuous drug delivery, DURYSTA ™ has the potential to dramatically shift the paradigm for dealing with glaucoma.”
The manufacturer is expanding its EyeCue ® reimbursement system to include DURYSTA. The system enables eye care professionals to register eligible people on a savings program to enable them to gain access to required therapies.

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