FORT WORTH, Texas, May 2, 2016 /PRNewswire/ -- Encore Vision, Inc., a privately-held ophthalmic pharmaceutical company dedicated to developing therapies for the treatment of presbyopia, announced today that the primary efficacy and safety endpoints have been met in its Phase I-II proof of concept study of EV06 ophthalmic solution 1.5%. EV06 is the first topical medical treatment directed at softening the gradual stiffening of the crystalline lens, a major underlying cause of presbyopia.
"We are encouraged by the positive safety and efficacy outcomes observed throughout the study in patients treated with EV06," said Bill Burns, President & Chief Executive Officer of Encore Vision. "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 (n=50) or placebo (n=25) 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.
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 (p=0.017) and continuing throughout the 90-day study period (p=0.005). EV06 outperformed placebo in objective and subjective measures throughout the study duration. Additional results will be presented on May 5, 2016 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. "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."
Presbyopia is the natural, gradual loss of the eye's ability to focus on nearby objects. It is generally noticeable around 40 to 45 years of age and caused by a stiffening of the lens of the eye. To focus on nearby objects, the human crystalline lens must be flexible enough to change shape by thickening at its center and increase its focusing power, which is referred to as accommodation. With age, the lens stiffens and loses elasticity thereby losing accommodative focusing power, manifesting in presbyopia. Presbyopia can have multiple effects on quality of vision and quality of life and if uncorrected, results in an inability to perform once-effortless near tasks at a customary working distance without experiencing visual symptoms.
Presbyopia is the most prevalent eye condition in the United States and by age 45, has often advanced to the point where some type of optical correction, such as reading glasses or bifocals, is required. An estimated 1.2 billion people worldwide in 2010 had presbyopia, and this number is expected to soar to nearly 2 billion by 2020. Although there are a number of approaches to managing the visual disability associated with presbyopia, all of the currently available treatments are compensatory rather than corrective.
About EV06 Ophthalmic Solution
EV06 (Lipoic Acid Choline Ester, 1.5%) is a first‐in‐class new chemical entity that targets a biochemical cause of presbyopia, believed to be associated with an increase in the formation of disulfide bonds between the crystalline proteins within lens fiber cells. EV06 is intended to increase lens flexibility by breaking these bonds, thereby restoring elasticity, allowing the lens to focus on nearby objects. EV06 is a prodrug that penetrates the cornea and is subsequently broken down into lipoic acid and choline, two naturally occurring substances. The lipoic acid in EV06 is reduced to dihydrolipoic acid in lens fiber cells and is responsible for breaking the disulfide bonds, therefore increasing lens flexibility. Administration of EV06 may potentially halt or reverse the stiffening that occurs, allowing the lens to maintain or regain its ability to accommodate.
About Encore Vision, Inc.
Encore Vision is a privately‐held eye care company focused on developing novel therapies for the treatment of presbyopia. Encore Vision's lead product candidate, EV06 ophthalmic solution, is based on its proprietary, patented pro‐drug technology that seeks to reverse the aging process responsible for presbyopia. In addition, Encore Vision is exploring additional methods and compounds to treat presbyopia. To learn more, visit http://www.encorevisioninc.com/.
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SOURCE Encore Vision, Inc.