Miotic Drops Improve Near Visual Acuity in Patients With Presbyopia

Instillation of 0.75% phentolamine ophthalmic solution (POS) alone or combined with 0.4% low-dose pilocarpine (LDP) may improve distance-corrected near visual acuity (DCNVA) in eyes with presbyopia, according to a poster presented at the American Academy of Optometry conference held October 26 to October 29 in San Diego, CA.    

A total of 147 participants in the VEGA-1 (ClinicalTrials.gov Identifier: NCT04675151)  multi-center, placebo-controlled, double-masked, phase 2 clinical trial, who had a DCNVA of 20/50 or worse, were randomized to treatment with 0.75% POS (n=73) or placebo (n=74). Study participants from both arms received treatment for 3 to 4 evenings followed by a morning treatment with (treatment group: n=43; placebo group, n=31) or without LDP. The primary endpoint was the percentage of patients who exhibited a 15 letter or more Early Treatment Diabetic Retinopathy Study (ETDRS) improvement 1 hour after drop instillation.  

According to the presenters, which included Mitchel Ibach, OD, 61% of participants who received POS combined with LDP treatment experienced a 15 letter or more ETDRS improvement compared with 28% of patients who received the placebo without a 5 or more letter loss in distance vision (P =.004). A total of 84% of participants receiving combined POS and LPD treatment achieved DCNVA of 20/40 or better and no adverse events or headaches were reported. 

“POS alone and POS with LDP had a favorable safety profile and significantly improved DCNVA without compromising distance vision,” according to the poster presenters. “Based on these results, POS alone and in combination will be advanced to Phase 3 trials.”