Presbyopia Temporarily Aided by Pilocarpine Drop Instillation

A 0.4% pilocarpine hydrochloride ophthalmic solution (CSF-1) provides temporary improvements in distance-corrected near visual acuity (DCNVA) and is safe and well-tolerated among patients, according to a poster presented at the American Academy of Optometry 2022 conference, held October 26 to October 29 in San Diego, CA. 

A total of 304 participants with presbyopia from the Near-Eye Vision Acuity Restoration (NEAR)-2 study (ClinicalTrials.gov Identifier: NCT04599972) participated in a randomized, double-masked, vehicle-controlled clinical trial and were assigned to treatment with CSF-1 (n=154) or a vehicle (n=150). Participants from both arms instilled 1 drop, twice per day and received follow-up on days 1, 8, and 15.

Key efficacy endpoints were the percentage of patients who experienced a 3 or more line improvement in DCNVA without a 1-line or greater loss in best distance corrected visual acuity at 4 timepoints (day 8, 1 and 2 hours post doses 1 and 2). Safety endpoints were Early Treatment Diabetic Retinopathy Study (ETDRS) BCDVA under mesopic and low luminance, slit lamp evaluation, conjunctival redness grading, ocular surface comfort, and adverse events. 

According to presenters Nate Lighthizer, OD, Jaclyn Garlich, OD, and Jade Coats, OD, participants randomized to treatment with CSF-1 had a higher percentage of individuals who met the efficacy endpoint compared with those receiving vehicle treatment at all timepoints. Participants undergoing CSF-1 treatment showed a trend towards BCDVA improvement with no decreases noted in low luminance BCDVA. Safety efficacy endpoints were comparable between both groups with minimal conjunctival redness noted among both arms and participants in both cohorts reported high levels of comfort with the drops. 

No adverse effects were reported among members in the CSF-1 group, but side effects such as blurred vision (7.2%), pain in the instillation site (5.9%), hyperemia (3.3%), and headache (9.8%) were noted.  

“CSF-1 demonstrated improved efficacy for the temporary treatment of presbyopia, with an excellent tolerability and safety profile,” according to the presenters.