Morrisville-based , a clinical-stage biotechnology company focused on developing novel therapies for eye diseases, has raised $16.5 million in additional Series A financing from existing investors.

The funding will support the accelerated development of Envisia’s extended-release ocular therapies for the three leading causes of preventable vision loss and blindness: glaucoma, diabetic macular edema and age-related macular degeneration.

“We are very pleased with the rapid progress we have made in the development of a portfolio of promising therapeutics and grateful for the continued support of our investors,” said President Benjamin Yerxa.

Envisia has a technology platform called PRINT that enables the rational design and manufacture of microparticle and nanoparticle systems of virtually any size, shape and chemistry, including nucleic acids, small-molecule and biologic active pharmaceutical ingredients, and polymeric drug delivery systems such as extended-release formulations.

The company’s lead product candidate, ENV515 for the treatment of glaucoma, is a fully biodegradable PRINT particle formulation of a marketed prostaglandin analog, travoprost, that has the potential to lower intraocular pressure in the eye for more than six months from a single dose. The company said the drug may be effective in addressing the issue of poor patient compliance that exists today with daily eye drops.

Patient enrollment has been completed for a low-dose formulation portion of a phase 2a study, and three-month safety and efficacy data are expected to be available in May 2016. A high-dose formulation cohort is expected to enter clinical testing by mid-year.

A second drug candidate, ENV1105 for the treatment of diabetic macular edema, is a fully biodegradable PRINT particle formulation of the steroid dexamethasone that would be injected into the eye for a six-month minimum duration of action. The company held a successful pre-Investigational New Drug meeting with the FDA in the first quarter of 2016, and expects to advance ENV1105 through preclinical testing and into clinical development in the first half of 2017.

A third drug candidate, ENV1305, to treat age-related macular degeneration, is a sustained-release monoclonal antibody that counteracts an over-abundance of a protein called vascular endothelial growth factor. Long-term preclinical studies to assess safety and pharmacokinetics are to begin in the middle of this year.

As many as 285 million people suffer from disease-related visual impairments and blindness, but an estimated 80 percent of these visual impairments are preventable, according to the World Health Organization.

The safety and effectiveness of many medical therapies for ocular disorders are limited due to poor drug uptake, non-specificity to target tissues, systemic side effects, or poor adherence to therapy, Envisia said. And with a rapidly aging population, the unmet medical needs of patients with ocular disease are becoming even more pronounced.

Envisia said it hopes to deliver next-generation particle therapies that improve delivery, safety and efficacy.

With sales of more than $15 billion in 2014, the global ophthalmology therapeutics market is expected to grow at a compound annual growth rate of more than 7 percent to reach nearly $25 billion in sales by 2020, according to one industry report. That rate is twice that of the pharmaceutical industry overall.

Envisia was established in 2013 as a spin-out of Liquidia Technologies, the Morrisville company that developed the PRINT platform of nanotechnology solutions for health care. Liquidia, itself, was spun out of the University of North Carolina at Chapel Hill in 2004 by superstar scientists Joe DeSimone and Ed Samulski.

Liquidia’s technology, based on techniques used in semiconductor manufacturing, is so game-changing that the company became the first equity investment made by the Bill and Melinda Gates Foundation. It can be used for vaccines, anti-cancer therapies – a huge array of applications.

Liquidia has also drawn investments from major pharmaceutical companies that want to use the PRINT technology on their own pipeline products.

(C) N.C. Biotechnology Center