Topical lipoic acid choline esterase drops for presbyopia appear to be safe and well-tolerated in an early efficacy study, which may point the way toward the future use of pharmacological treatment options for improving near vision.
Study Design
This prospective, randomized, double-masked, multi-center clinical trial studied improvement in near vision with topical lipoic acid choline esterase (UNR844, 1.5%) while also evaluating the safety profile of this treatment. UNR844 was administered twice daily to 49 patients; 23 patients received placebo. After a 91-day period, 52 patients opted to continue a second phase of monitoring until 7 months post-treatment. All patients were between the ages of 45 and 55 years.
Outcomes
Patients in the UNR844 treatment group experienced significantly greater mean improvement in distance-corrected near visual acuity (DCNVA) than those in the placebo group (mean change of −0.189 vs −0.089, P = 0.007). The number of patients with consistent DCNVA improvements of 10 or more letters was also higher in the treatment group. No safety concerns were reported, and distance visual acuity was unaffected. These results were sustained for months after drop use ceased.
Limitations
Possible shortcomings of this study include unexpected improvement in near visual acuity in the placebo group, which may diminish some significance of the treatment group results. The number of subjects enrolled in the study was small.
Clinical Significance
For practices that focus on presbyopic correction, particularly with a surgical approach, having a pharmacological treatment option for presbyopia may be beneficial. Therapeutic presbyopia treatments could be offered to patients with early-stage presbyopia, for whom other medical or surgical options currently don't exist, and help these patients until they are candidates for refractive lens replacement surgery. Unfortunately, Novartis recently halted phase two trials for lipoic acid choline esterase, so this specific eyedrop is not likely to become available.
Financial Disclosures: Dr. Ronald Luke Rebenitsch discloses financial relationships with Carl Zeiss Meditec (Consultant/Advisor); FDA Ophthalmic Devices Committee (Consultant/Advisor); Legrande (Consultant/Advisor, Equity/Stock Holder - Private); LENSAR (Lecture Fees/Speakers Bureau); OSRX Pharmaceuticals (Consultant/Advisor, Lecture Fees/Speakers Bureau, Stock Options - Public or Private); STAAR Surgical (Lecture Fees/Speakers Bureau).