Ophthalmic pharmaceutical company Encore Vision recently announced that primary efficacy and safety endpoints have been met in its Phase I-II proof of concept study of EV06 ophthalmic solution 1.5% — reportedly the first topical medical treatment for softening the gradual stiffening of the crystalline lens, a major underlying cause of presbyopia.
The Phase I-II study consisted 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 that were randomized 2:1 to receive one drop of EV06 (n=50) or placebo (n=25) twice daily over 90 days. The study reportedly found significant improvement of DCNVA from baseline in the EV06 group compared to the placebo, with onset of DCNVA improvement beginning at day 15 (p=0.017) and continuing throughout the 90‐day study period (p=0.005).
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