Encore Vision Inc. on Monday announced that the primary efficacy and safety parameters have been met in its Phase I-II proof of concept study of the company’s EV06 ophthalmic solution. EV06 is the first topical medical treatment designed to treat the underlying cause of presbyopia, the natural, gradual loss of the eye’s ability to focus on nearby objects.
“We are encouraged by the positive safety and efficacy outcomes observed throughout the study in patients treated with EV06,” said Bill Burns, a former executive with Alcon Labs, is Encore’s president and CEO. “EV06 demonstrated a safety profile nearly identical to placebo and a significant ability to improve near vision function as early as 2 weeks. We believe these data warrant future clinical development.”
The Phase I‐II randomized, double‐masked, multicenter study examined the safety and efficacy of EV06 compared to placebo for the treatment of presbyopia. A total of 75 subjects between the ages of 45 and 55 with distance corrected near visual acuity (DCNVA) worse than 20/40 and best corrected distance visual acuity (BCDVA) of 20/20 or better in each eye were randomized 2:1 to receive one drop of EV06 or placebo twice daily over 90 days. The mean change in DCNVA and BCDVA was evaluated throughout the study, along with secondary efficacy outcomes and safety parameters, according to a news release.
The study met both primary safety and efficacy outcomes. A significant improvement of DCNVA from baseline was observed in the EV06 group compared to placebo, with onset of DCNVA improvement beginning at day 15 and continuing throughout the 90‐day study period. EV06 outperformed placebo in objective and subjective measures throughout the study duration. Additional results will be presented on May 5 during the Ophthalmology Innovation Showcase at the 2016 Ophthalmology Innovation Summit at the American Society of Cataract and Refractive Surgeons Symposium (OIS@ASCRS) in New Orleans, Louisiana.
“To our knowledge, this study is the first of its kind,” said Dr. John Hunkeler, founder and medical director of Hunkeler Eye Institute in the news release. “EV06 is the only investigational treatment that addresses the root cause of presbyopia. The marked improvement in near vision over the entire study period coupled with the fact that EV06 was very well tolerated makes me optimistic this innovative treatment could provide substantial functional and quality‐of‐life improvements for our presbyopic patients. While further study is required, if successful, EV06 could redefine how we manage presbyopia – the most common ophthalmic condition worldwide.”
Fort Worth-based Encore Vision has been a client company at TECH Fort Worth for several years, which also provides lab space at the University of North Texas Health Science Center. The company has raised more than $10 million with Fort Worth’s angel investment group, Cowtown Angels providing $1.25 million. The company’s main goal has been the development of EV06, a compound designed to soften the lens in the eye, which could help as many as 100 million people globally who suffer from presbyopia.