Novel lipoic acid choline ester eye drops safe, promising against presbyopia

UNR844, an investigational topical lipoic acid choline ester eye drop, is safe and well-tolerated for the treatment of presbyopia and yields improvements in distance-corrected near visual acuity (DCNVA), a recent study has found.

“Currently, there are no approved pharmacological therapies designed to treat presbyopia. External ocular lenses, such as spectacles or contact lenses, are typically used to correct vision,” the researchers said. “This study demonstrates that UNR844 has the potential to be a first-in-class disease modifying pharmacological therapy for presbyopia.”

The prospective, randomized, double-masked, multicentre trial included 75 presbyopia patients who were allocated to receive UNR844 or placebo at a 2:1 ratio. Interventions were first administered unilaterally to assess safety, followed by bilateral twice-daily drops for efficacy evaluation. Outcomes included DCNVA and adverse events (AE).

Bilateral data showed that UNR844 treatment induced progressive improvement in DCNVA in the study eye through 91 days of intervention as compared with placebo (mean change, –0.189 vs –0.089 logMAR; p=0.001). A significantly higher percentage of UNR844-treated participants also gained ≥10 letters in bilateral near vision (53.1 percent vs 21.7 percent; p=0.021).

Notably, such improvements in DCNVA after UNR844 treatment persisted until 5 and 7 months after the final eye drop dose.

In terms of safety, 22 percent and 12 percent of participants in the UNR844 and placebo groups, respectively, saw drug-related treatment-emergent AEs, all of which were mild to moderate in intensity. No severe AEs, discontinuations, or deaths occurred during the study period.