Encore Vision’s EV06 ophthalmic solution (lipoic acid choline ester 1.5%) is “a prodrug that metabolizes into choline and lipoid acid, two naturally occurring substances,” that may be able to topically treat the causes of presbyopia, said company president and chief executive office Bill Burns.
Encore Vision researchers found that excessive disulphide bond formation in human lens eye bank lenses may lead to a loss of lens flexibility, and when oxidation-induced disulphide bonds form between crystalline proteins, lens stiffening occurs and that creates compromised accommodation, he said. Once EV06 has been administered, enzymes within the lens fiber cells chemically reduce lipoic acid to actively form dihydrolipoic acid, which in turn reduces the disulphide bonds and restores lens microfluidics.
Results from a Phase I/II clinical study on 75 subjects randomized 2:1 to EV06 or placebo drops twice daily found a gain of at least 10 letters from Day 1 to Day 91 in distance-corrected near visual acuity in the non-dominant eye, but also in bilateral vision, in more than half the subjects in the EV06 arm.
“EV06 improved near vision over time in the non-dominant eye, distance vision in the dominant eye, and improved bilateral near vision over time,” Burns explained. Plus, 22% of patients in the EV06 arm gained 3 lines of vision, and 12% gained 4 lines. An aberrometer confirmed changes in higher order aberrations on order of –3.0 D in the central lens refractive power.
None of the patients in the EV06 arm lost any distance vision, and 16% had no change in distance vision. The company is enrolling patients in an EV06 post-treatment study with a last subject/last visit expected in October 2016.
Encore Vision will start a Phase IIb dose-ranging study in first-quarter 2017, and pivotal Phase III studies on the drops in second-quarter 2018, Burns said.
Mr. Burns is President and CEO of Encore Vision, Inc. (2006 – Present) and also serves as a member of the Encore Vision Board of Directors.