This company, founded as a spin-out of Liquidia Technologies in 2013, began with a $25 million Series A, with the goal of developing the PRINT particle platform for ophthalmic indications. The PRINT platform can be applied to make “very precise drug delivery systems for the eye,” Dr. Yerxa said, as anything that can be manufactured on a silicon wafer can be adapted.
Envisia uses a master template for ENV515, its glaucoma implant. The template varies in sizes from nanoparticles to something as large as several millimeters. A “Teflon-like polymer” is poured over the top of the template to allow it to peel off in a sheet, or reverse mold. Those molds are where the active ingredients reside.
The company’s lead products, ENV515-3 and -1, are in Phase II studies for glaucoma, with an expected duration of six months. ENV515 uses travoprost as its active ingredient. Initial studies enrolled patients already scheduled to have cataract surgery. ENV515 was placed and removed four weeks later during the cataract surgery; the fellow eye was dosed with Travatan Z (travoprost) as an internal control. The median interim IOP change from baseline showed the high dose ENV515-3 versus Travatan Z were numerically equivalent, with a 28% drop in pressure and with a 6.7 mmHg drop in IOP. The low-dose (ENV515-1) and with the low dose showing about a 20% drop in pressure. The company is working toward optimizing for its anticipated phase 3 study.The firm is working toward optimization for its anticipated Phase III study.
EnVisia is also looking to develop its technologies for posterior segment diseases. Early monkey studies have indicated good performance and clean safety profiles in a VEGF-challenge model. A small-molecule rod-like structure will evaluate dexamethasone for diabetic macular edema; that study is expected to begin in 2017.
ENV905 (difluprednate) is in development for postop inflammation. Rabbit studies showed one administration of ENV905 to perform better than a four-times-daily steroid.
Benjamin Yerxa, PhD
Dr. Yerxa is President of Envisia Therapeutics, a spin out of Liquidia Technologies. Previously, he was the CSO for both Liquidia and Envisia and joined Liquidia from Clearside Biomedical.