Encore Vision Inc. said last week that the U.S. Food and Drug Administration has given Encore’s Investigational New Drug application an approval as safe, allowing the Fort Worth-based company to proceed with clinical development of a treatment for presbyopia.
Presbyopia is a visual condition that develops around age 40 that often leads to reading glasses. Encore says that since that approval it has enrolled the first subject into their Phase 1 and 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 CEO of Encore Vision. “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.”
Encore’s product, 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, according to the company. The Phase 1 and 2 prospective, 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.
In 2014, the company completed a $1.7 million round of funding to help develop EV06.