MAY 06, 2016
An early-stage study of an eye drop that softens the presbyopic crystalline lens shows that it is safe and may restore some accommodation.
“The positive results in favor of EV06 across multiple safety and efficacy endpoints provide a positive step forward in the development of the first ophthalmic drop addressing the root cause of presbyopia,” said Richard L. Lindstrom, MD, founder of Minnesota Eye Consultants and professor at the University of Minnesota.
Developed by Encore Vision, EV06 (lipoic acid choline ester 1.5%) is a novel chemical that breaks disulfide bonds between the crystalline proteins within lens fiber cells. The prodrug is designed to penetrate the cornea and metabolize into dihydrolipoic acid in lens fiber cells to increase lens flexibility and restore elasticity.
In the phase 1/2 randomized, double-masked study, 75 subjects received either 1 drop of EV06 or placebo twice daily for more than 90 days. The treated group showed significant improvement in distance corrected near visual acuity (DCNVA), beginning as early as day 15 (P=0.017).
By Day 91, 82% had 20/40 DCNVA or better in the EV06 group compared to 48% in placebo, with baseline values of 30% and 28%, respectively. Similarly, 60% of EV06‐treated subjects had 20/32 DCNVA or better at Day 91 compared to only 24% in placebo; the baseline value for this measure in both groups was 8%. EV06 was also well tolerated, with a comparable comfort rating to the placebo group.