Encore Vision completes enrollment in clinical study evaluating topical EV06 to treat presbyopia

Encore Vision president and CEO Bill Burns said: "We are pleased to confirm that 75 subjects have been enrolled in the study and to date, there have been no safety or tolerability issues.

"Reaching this enrollment milestone in just three short months is an impressive achievement and a testament to our investigators. It also highlights the significant unmet medical need of presbyopic patients. We are eager to share the results from this study in the second quarter of 2016."

Presbyopia is the loss of accommodative function that develops in most everyone around age 40, affecting over a billion people worldwide. Common signs of presbyopia include holding printed material at a distance in order to focus clearly and difficulty reading a menu in low light conditions.

The Phase 1/2 prospective, randomized, double-masked, multicenter study is examining the safety and efficacy of EV06 compared to placebo over 90 days for the treatment of presbyopia.

Four sites across the United States enrolled 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. The study population includes subjects who did not require any visual correction prior to the onset of presbyopia (i.e., emmotropes) as well as myopes and hyperopes.

Mean change in DCNVA and BCDVA is being evaluated throughout the study, along with additional secondary outcomes. The use of these eye drops on a daily basis has been well accepted during the current study and, thus far, no test subjects have discontinued for study drug related reasons.

"Corrective lenses, often called "readers", are the most commonly used method for managing presbyopia today," said David Evans, OD, from Total Eye Care, Memphis, Tennessee, an investigator in the trial.

"The idea of having a pharmaceutical treatment option for my patients that could reduce spectacle dependence is truly exciting. If successful in this and future studies, I believe EV06 could revolutionize how we approach one of the most common struggles that comes with aging."

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.