FORT WORTH, Texas, Oct. 5, 2015 /PRNewswire/ -- Encore Vision, Inc., a privately-held ophthalmic pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Encore's Investigational New Drug (IND) application as safe to proceed with the clinical development of EV06 topical ophthalmic solution to treat presbyopia. Presbyopia is a visual condition that develops around age 40 when it becomes apparent that reading glasses, commonly referred to as "readers", are needed to focus clearly on nearby objects, such as reading a newspaper. The company has since enrolled the first subject into their Phase 1 & 2 trial, which it believes to be the first ever clinical evaluation of a new chemical entity intended to address an underlying process that causes presbyopia.
"The FDA clearance of our IND for EV06 and subsequent enrollment of the first patient into our study are two significant milestones for Encore Vision," said Bill Burns, President and Chief Executive Officer of Encore Vision, Inc. "Our company was founded with the goal of developing treatments for presbyopia, which affects 9 out of 10 Americans over 40. EV06 ophthalmic solution addresses stiffening of the lens, thought to be a root cause of presbyopia. We are excited to advance the clinical development of EV06 and bring this novel therapeutic treatment one step closer to over a billion people affected by presbyopia worldwide."
EV06 is an investigational proprietary lipoic acid choline ester compound that is being developed to treat presbyopia by reversing age-related changes in the crystalline lens that result in diminished lens elasticity. The Phase 1 & 2 prospective, randomized, double-masked, multicenter study will compare the safety and efficacy of EV06 to placebo in subjects 45 to 55 years of age with presbyopia. The 90-day study will aim to enroll 72 subjects and evaluate mean change in distance corrected near visual acuity (DCNVA) and best corrected distance visual acuity (BCDVA), along with additional secondary outcomes.
"To have a pharmaceutical therapy that could effectively reduce dependence on bifocals or reading glasses is truly a groundbreaking approach in the treatment of presbyopia," stated Richard Lindstrom, MD, founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus of Ophthalmology at the University of Minnesota, Department of Ophthalmology. "If EV06 proves successful in the clinic, this will be a major shift in how we treat the massive presbyopic population."
Presbyopia is the natural, gradual loss of the eyes' 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 change its focusing power in order to "accommodate". 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 1.7 billion people worldwide have presbyopia, and this number is expected to soar to 2.1 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. 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/.
SOURCE Encore Vision, Inc.