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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

Poster Details

First Author: J.Till USA

Co Author(s):    M. Lai                    

Abstract Details

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 b.i.d. dosing with lipoic acid choline ester eye drops (UNR844 Ophthalmic Solution, 1.5%) compared to vehicle control (Placebo). The current study followed a cohort of the original study�â�€�™s population for 7 months after cessation of their assigned treatment to determine the duration of the investigational product�â�€�™s effects.

Setting:

Follow-up study of a cohort from the clinical trial NCT02516306, which was a phase 1/2 prospective, randomized, double-masked, placebo-controlled, multicenter study to evaluate the safety and efficacy of UNR844 ophthalmic solution (lipoic acid choline ester, 1.5%), in improving DCNVA in subjects with presbyopia.

Methods:

All subjects who successfully completed the 90-day randomized, double-masked, controlled study of UNR844 vs. placebo were eligible for enrollment. Subjects had dosed unilaterally on Days 1-7 (b.i.d) and bilaterally on Days 8-91 (b.i.d). 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 (Early Treatment Diabetic Retinopathy Study (ETDRS) charts) and safety.

Results:

A cohort of 52 subjects were enrolled in this 7-month follow-up study: 34 had previously received UNR844 and 18 had previously received placebo. Bilateral improvements in near vision achieved during the original UNR844 treatment period were maintained for 5-7 months. At the end of the initial 90-day dosing period, bilateral DCNVA was significantly different in the UNR844 group compared to the placebo group [(Mean LogMAR �Â�± SEM) UNR844 0.201�Â�±0.036 vs placebo 0.311�Â�±0.022; p=0.011]. This difference was also observed at 150 days (UNR844 0.228�Â�±0.031 vs placebo 0.352�Â�±0.032; p=0.008) and 210 days (UNR844 0.245�Â�±0.037 vs placebo 0.348�Â�±0.032;p=0.042).

Conclusions:

These results suggest that the gains in DCNVA attributed to dosing with UNR844 Ophthalmic Solution for 90 days in presbyopes persist for at least an additional 210 days after the last exposure.

Financial Disclosure:

is employed by a for-profit company with an interest in the subject of the presentation, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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