An observational follow-up study assessing the long-term effects of bilaterally dosed topical lipoic acid choline ester eye drops for the treatment of presbyopia

Purpose: Few pharmacological options are in development for the treatment of presbyopia, and the durability of these options is not well known. A recent clinical study (NCT02516306) in presbyopes demonstrated statistically and clinically significant improvement in distance corrected near vision acuity (DCNVA) following BID dosing with lipoic acid choline ester eye drops (EV06 Ophthalmic Solution, 1.5%) compared to vehicle control (Placebo). The current study followed a cohort of the original study's population for 7 months after cessation of their assigned treatment to determine the duration of the investigational product's effects. Methods: All subjects who successfully completed the 90-day randomized, double-masked, controlled study of EV06 vs. Placebo were eligible for enrollment. Subjects had been initially dosed unilaterally on Days 1-7 (BID) to ensure safety, and then bilaterally on Days 8-91 (BID). During this single-masked follow-up study, subjects were observed at 150 and 210 days following their last treatment to assess long-term effects on near and distance visual acuity (ETDRS charts; M&S System) and safety. Results: A cohort of 52 of the 72 subjects (72.2%) who successfully completed the original evaluation elected to enroll in this 7-month follow-up study: 34 previously had received EV06 and 18 previously had received Placebo. None of the subjects were lost to follow-up. Preliminary results indicate that the bilateral improvements in near vision that were gained during the original treatment period were maintained for 5-7 months after the last dose of EV06 was administered. At the end of the initial 90-day dosing period, the cohort of the present study had a statistically significant difference in bilateral DCNVA when the EV06 treatment group was compared to the Placebo group [(Mean LogMAR ± SEM) EV06 0.201 ±0.036 vs Placebo 0.311 ±0.022; p=0.011]. This difference was also observed 150 days (EV06 0.228±0.031 vs Placebo 0.352±0.032; p=0.008) and 210 days (EV06 0.245±0.037 vs Placebo 0.348±0.032; p=0.042) post-dosing. Additional safety and efficacy data will be presented. Conclusions: These results suggest that the gains in DCNVA attributed to dosing with EV06 Ophthalmic Solution for 90 days in presbyopes persist for at least an additional 210 days after the last exposure to the study article.