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Envisia begins Phase IIa trial of ENV515 to treat glaucoma patients

US-based biotechnology firm Envisia Therapeutics has started a Phase IIa clinical trial designed to evaluate the safety and tolerability of its lead product, ENV515, in patients with glaucoma.

The company said that ENV515 is a fully biodegradable particle replication in non-wetting templates (PRINT) particle formulation of a prostaglandin analog, travoprost, with the potential for sustained intraocular pressure (IOP) reduction over as many as six months.

Envisia chief executive officer Neal Fowler said: "We are excited to advance ENV515 into clinical development only a year after forming the company, an accomplishment we are very proud of.

"The progress made with ENV515 underscores the power and flexibility of the PRINT technology to rapidly develop and advance promising product candidates, simultaneously, across multiple areas of interest in ophthalmology."

The open-label Phase IIa trial will enroll 20 glaucoma patients at sites within the US and results are expected to be reported by mid-2015.

Envisia chief scientific officer Ben Yerxa said: "The PRINT technology has been key in the development and testing of a wide range of product parameters that were ultimately used to identify the ENV515 formulation currently being advanced in this clinical trial.

"While the primary goal of this first study is to assess the product’s short-term safety, the long-term goal is to ensure this formulation is also able to provide sustained relief to glaucoma patients for several months from a single dose."

The company uses the PRINT technology to create particle-based ocular therapeutics, which can deliver both small and large molecules in multiple formats.