A phase I/II clinical study evaluating the safety and preliminary efficacy of a bilateral topical lipoic acid choline ester eye drop treatment to reverse presbyopia

Session Details

Session Title: Corneal, Scleral and Pharmaceutical Treatment of Presbyopia

Session Date/Time: Monday 09/10/2017 | 16:30-18:00

Paper Time: 17:40

Venue: Meeting Center Room I

First Author: : J.Till USA

Co Author(s): :    M. Lai                    

Abstract Details

Purpose:

There are no currently approved pharmacological therapies designed to treat presbyopia, a condition thought to be related in large part to the increased concentration of crystalline lens disulfide bonds whose presence leads to a loss of lens flexibility. Lipoic acid is an antioxidant shown to chemically reduce lens disulfide bonds, thus allowing greater cytosol displacement resulting in increased lens refractive power during accommodation. The purpose of this study was to evaluate the topical bilateral use of a lipoic acid choline ester formulation (UNR844 Ophthalmic Solution, 1.5%) on distance corrected near visual acuity (DCNVA) in a sample of presbyopes.

Setting:

First-in-man, Phase I/II, randomized, double-masked, placebo controlled study.

Methods:

75 subjects were recruited at 4 sites, with 72 of 75 randomized subjects completing the study (UNR844 n=49; Placebo n=23). Subjects were generally healthy males or females, 45-55 years old meeting eligibility criteria including 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 Early Treatment Diabetic Retinopathy Study charts (M&S System). Following informed consent, subjects were randomized to UNR844 (n=50) or Placebo (n=25). On Days 1-7, all subjects dosed unilaterally (b.i.d.) to ensure safety prior to Days 8–91 when dosing was bilateral (b.i.d.).

Results:

Bilateral DCNVA improved in the UNR844 Group compared to the Placebo Group from Day 1 to Day 91 (Placebo vs UNR844, mean change ± SEM; -0.089 ± 0.019 vs -0.189 ± 0.019 LogMAR; p=0.001). At baseline, 30% and 28% of subjects in the UNR844 and Placebo Groups, respectively, had DCNVA OU ≥20/40 compared to 82% and 48% on Day 91, respectively. No statistically significant changes were observed in best corrected distance visual acuity, pupil size or intraocular pressure, and there were no discontinuations due to drug-related ocular adverse events.

Conclusions:

These results support further development of UNR844 Ophthalmic Solution for the treatment of presbyopia.

Financial Disclosure:

is employed by a forNONEprofit 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