Michael S. Korenfeld is an ophthalmologist and the owner of a private practice. He is also an Assistant Clinical Professor at the Washington University School of Medicine.
Download the poster (.pdf), which was originally shared at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, 2017.
A Phase I/II clinical study evaluating the safety and effectiveness of a topical lipoic acid choline ester eye drop on presbyopia
Michael S. Korenfeld,1,2 David G. Evan,3 Steven H. Rauchman,4 Kenneth N. Sall,5 Jerry M. Stein,6 Stella M. Robertson,7 Travis Whitfill,8 Judy Gordon,9 William Burns,10 Adrian Glasser11
1 Ophthalmology and Visual Sciences, Washington University, St. Louis, Missouri, United States
2 Ophthalmology and Visual Sciences, Comprehensive Eye Care, Ltd, Washington, Missouri, United States
3 Total Eye Care, PA, Memphis, Tennessee, United States
4 North Valley Eye Medical Group, Mission Hills, California, United States
5 Sall Research Medical Center, Artesia, California, United States
6 Summer Creek Consulting, LLC, Fort Worth, Texas, United States
7 Arrochar Consulting, LLC, Fort Worth, Texas, United States
8 Bios Partners, Fort Worth, Texas, United States
9 ClinReg Consulting Services, Inc, Laguna Beach, California, United States
10 Encore Vision, Inc, Fort Worth, Texas, United States
11 Adrian Glasser Consulting Services, Tampa, Florida, United States
Lipoic acid (LA) is an antioxidant shown to chemically reduce disulfide bonds and allow greater cytosol displacement in crystalline lenses preclinically (Garner and Garner, 2016). This pharmacologic activity has the potential to improve distance corrected near vision in presbyopes. An LA choline ester (EV06 Ophthalmic Solution, 1.5%) was formulated to deliver a clinically effective concentration of LA to the lens when dosed topically.
Purpose: This first-in-humans study was a preliminary assessment of EV06 safety and efficacy for the treatment of presbyopia.
Methods: 75 subjects were recruited at 4 sites in a randomized, double-masked, placebo controlled study. Subjects were generally healthy males or females, 45-55 years old meeting eligibility criteria including Distance Corrected Near Visual Acuity (DCNVA) worse than 20/40 in each eye and manifest refraction spherical equivalent between or equal to +4.0D to -4.0D. DCNVA was assessed using EDTRS charts (M&S CTS System). Following informed consent, subjects were randomized to EV06 (n = 50) or placebo (n = 25). On Days 1-7, all subjects dosed unilaterally (bid) to ensure safety prior to Days 8–91 when dosing was bilateral (bid).
Results: Acceptable safety was indicated. 72 of 75 subjects completed the study (EV06 n = 49; placebo n = 23) and no subjects discontinued for drug related ocular adverse events. Improvement in DCNVA was observed in the EV06 group compared to the placebo group, with the onset of statistically significant differences in DCNVA OU beginning on Day 15 (placebo vs EV06, mean ± SEM; 0.375 ± 0.028 vs 0.290 ± 0.021 LogMAR; p = 0.017) and continuing throughout the 3-month study (Day 91: 0.313 ± 0.030 vs 0.206 ± 0.021 LogMAR; p = 0.005). The percentage of subjects with DCNVA OU of 20/32 or better at baseline was 8.0% in both the EV06 and placebo groups (p = 1.00) compared to 60.0% and 24.0% on Day 91 (p = 0.004), respectively.
Conclusions: These results support further development of this treatment.
