Compliance with topical medication drops to manage glaucoma “is horrid,” said Benjamin Yerxa, PhD, co-founder and president, Envisia Therapeutics. Poor compliance results in disease progression, but even with the advances in surgeries and drainage devices, “we’ve made great progress, but these are not appropriate for everyone,” he said.
Ideally, patients should be receiving full prostaglandin efficacy “24/7 – and ideally with more than six months’ duration from a single dose” in a sustained delivery model, Dr. Yerxa asserted. Other considerations must include easy administration, less hyperemia than drops, full biodegradability, and excellent safety profiles.
To that end, Envisia in-licensed PRINT technology that can provide “unparalleled precision and reproducibility,” Dr. Yerxa said. PRINT is a proprietary system capable of engineering highly precise microparticle and nanoparticle systems that offer a means to rationally design precise particles of virtually any size, shape, and chemistry, including small-molecule active pharmaceutical ingredients (APIs), biological APIs, and polymeric drug delivery systems (e.g., extended-release formulations).
Envisia is using the technology to create an intracameral device that will deliver travoprost next to the target tissue; the procedure can be easily performed in office, according to Dr. Yerxa.
Intraocular pressure (IOP) lowering has been shown to be comparable to Travatan Z, and in the ENV515 (travoprost XR) Phase II trial, patients with open-angle glaucoma had a “meaningful reduction in IOP for the entire nine-month evaluation period following a single administration,” he noted.
ENV515 also demonstrated an intraocular pressure (IOP) lowering effect comparable to pre-study topical prostaglandin analogs (bimatoprost and latanoprost) and in-study topical timolol maleate 0.5% ophthalmic solution (daily eyedrops).
Envisia has started a high-dose study cohort; nine-month results in beagle eyes showed about a 10 mm Hg decrease that was maintained from about day 14 onwards.
In glaucoma, ENV515 is expected to enter Phase III studies in 2018, ENV1105 for diabetic macular edema should enter Phase II studies in mid-2017, and ENV1305 (aflibercept) for neovascular age-related macular degeneration is still in preclinical studies.
To date, ENV1105 is showing a linear release of dexamethasone with upwards of six-month duration, Dr. Yerxa said.
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.