November 16, 2015
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ENV515 appears safe in removal of cataracts in glaucoma patients

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LAS VEGAS — ENV515 travoprost XR intracameral implant appeared to be safe when used during cataract removal in patients with glaucoma, according to phase 2a clinical trial findings presented here.

“All patients completed the study per protocol with no early discontinuations,” Tom R. Walters, MD, said at the American Academy of Ophthalmology annual meeting. “One hundred percent of implants were safely removed and aqueous humor was sampled for drug level analysis.”

Tom R. Walters

ENV515 (Envisia Therapeutics) was administered to 21 patients with glaucoma 28 days before their scheduled cataract surgery and was followed by safety and IOP evaluations, Walters said. All implants were successfully recovered, and no adverse events were reported.

“The results enabled selection of ENV515 formulation to progress to a long-term, 12-month safety and efficacy study,” Walters said.

The results from the trial may be useful to other researchers to study extended-release therapies, he said. — by Nhu Te

Reference:

Walters T. Development and validation of a novel clinical trial design for extended-release intracameral therapies for glaucoma. Presented at: The American Academy of Ophthalmology. Nov. 15; Las Vegas.

Disclosure: Walters reports that he is an investigator in the trial and a consultant for Envisia Therapeutics.