[January 27, 2015]

Envisia Therapeutics Initiates Phase 2a Clinical Trial for ENV515 in Patients with Glaucoma

Envisia Therapeutics today announced that it has initiated a phase 2a clinical trial to investigate the safety and tolerability of its lead product, ENV515, in patients with glaucoma. ENV515 is a proprietary, fully biodegradable PRINT® (Particle Replication In Non-Wetting Templates) particle formulation of a prostaglandin analog, travoprost, with the potential for sustained intraocular pressure (IOP) reduction over as many as six months. ENV515 offers the potential to significantly address the poor compliance that exists among glaucoma patients today to limit disease progression and vision loss.

"We are excited to advance ENV515 into clinical development only a year after forming the company, an accomplishment we are very proud of," said Neal Fowler, Chief Executive Officer at Envisia. "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 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," said Ben Yerxa, PhD, Chief Scientific Officer at Envisia. "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 phase 2a clinical trial is designed as an open-label study that will enroll 20 glaucoma patients at sites within the US. Results from this clinical trial are anticipated by mid-2015.

"Poor patient compliance has long been a significant challenge in the treatment of glaucoma, making it a leading cause of preventable blindness in the US today," said Steven L. Mansberger, M.D., MPH, the lead investigator for the ENV515 trial and Vice-Chair, Director of Glaucoma Services at Devers Eye Institute. "Investigational products such as ENV515 have the potential to transform the treatment of glaucoma by removing compliance barriers and providing sustained reduction of intraocular pressure."

Envisia uses the power of the proprietary PRINT technology to create particle-based ocular therapeutics, which can deliver both small and large molecules in multiple formats. Envisia is also exploring how the company's unique technology can address other important ocular diseases, such as AMD (News - Alert) and ocular inflammation.

ABOUT ENVISIA THERAPEUTICS™

Envisia Therapeutics, formed by Liquidia Technologies in 2013, is a privately held biotechnology company focused on the development of novel ocular therapies. Envisia is leveraging the unique and powerful properties of the PRINT® technology to develop therapies for a variety of ocular conditions, beginning with ENV515 for glaucoma. ENV515 is a novel, extended-release formulation of a marketed prostaglandin analogue with the potential to significantly limit disease progression and vision loss through improved product performance and patient compliance. Envisia is located in Research Triangle Park, North Carolina. For more information, please go to www.envisiatherapeutics.com.

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