Presbyopic patients who were treated with EV06 ophthalmic solution showed an improvement in visual outcomes in a phase 1/2 study, Encore Vision announced in a press release.
“This clinical trial was designed to confirm or not confirm that topically applied lipoic acid at a concentration of 1.5% could increase the elasticity of the human lens and enhance accommodation,” OSN Chief Medical Editor Richard L. Lindstrom, MD, told Ocular Surgery News.
Richard L. Lindstrom
The phase 1/2 prospective, randomized, double-masked, multicenter study included 50 patients who were treated twice daily with EV06 (lipoic acid choline ester 1.5%) and 25 patients who were treated twice daily with placebo. Patients were enrolled at four U.S. sites.
“We ended up with some pretty impressive outcomes showing that we can enhance accommodation and improve near vision with a topical drop,” Lindstrom said.
At 3 months, 82% of patients in the EV06 group had distance corrected near visual acuity (DCNVA) of 20/40 or better compared with 48% of patients in the placebo group, and 60% of patients in the EV06 group had DCNVA of 20/32 or better compared with 24% of patients in the placebo group.
“At the end of 3 months, the difference between the treated group and the placebo group continued to grow, which suggests that if continued longer, you would continue to see a greater effect than we measured at 3 months,” Lindstrom said.
Lindstrom anticipates the next steps are to conduct two phase 3 clinical trials to confirm the outcomes of the phase 1/2 clinical trial.
Disclosure: Lindstrom reports he is on the board of directors of and owns equity in Encore Vision.