Results from a Phase I/Phase II study of EV06 ophthalmic solution for the treatment of presbyopia show “it works to restore bilateral near vision. It is safe and well-tolerated,” said president and CEO Bill Burns.
Encore Vision has just come off a round of successful capital financing that should see it through the next phase of development.
EV06 works to restore natural function to the lens; excessive cross-linking is considered a leading potential cause of increased lens stiffening, which results in the loss of accommodative focusing power, Burns said. EV06 is a patented prodrug of lipoic acid choline ester, 1.5%. Once it penetrates into the cornea, it is metabolized into two naturally occurring substances that are lacking in a presbyopic eye. Once taken up by the lens, lipoic acid is further hydrolized into dihydrolipoic acid.
“This restores a more fluid component to the lens fiber cells,” Burns said.
The study design enrolled 75 presbyopic subjects with hyperopia, myopia, or emmetropia; on days 1 through 7, 50 patients were dosed unilaterally with EV06, and 25 were assigned to placebo. On days 7 through 90, patients went to bilateral dosing.
“We wanted to treat for the first week to ensure the drop was well tolerated,” Burns explained. Mean age was 50.5 years, most were women (71%), most were Caucasian (70.7%), and most were presbyopic emmetropes (68%). There were no changes in best corrected distance visual acuity or pupil diameter. Results showed a higher proportion of subjects gained at least 10 letters of improvement versus placebo. By day 90, about 35% of the EV06 group had gained at least 2 lines of vision.
“Additional study is warranted,” which will evaluate duration of treatment effect at 120 and 270 days post-dosing, said Burns.
Bill Burns: 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.