Purpose:

The purpose of this study was to assess the safety, tolerability and efficacy of daily administration of PresbiDrops (Orasis Pharmaceuticals, Herzliya, Israel) in presbyopic subjects.

Methods:

In this phase 2a, multicenter, double-masked, randomized, placebo-controlled, repeated administration, crossover study 36 subjects with presbyopia aged between 44 and 62 years were enrolled. Subjects were randomized in a 1:1 ratio to one of two treatment arms: PresbiDrops and placebo. The subjects self-administered the treatment for two weeks. Following a 24-hour wash out interval, a cross-over was performed and those initially treated with PresbiDrops received placebo and vice versa. The main efficacy outcome measures were percentage of participants with a ≥ 2 line improvement from baseline in binocular uncorrected near visual acuity (UNVA) in high and low illumination settings.

Results:

The rate of two line improvement was significantly higher with PresbiDrops compared to placebo in both high illumination (41.7% versus 22.2% respectively, p=0.04) and low illumination (41.7% versus 16.7% respectively, p=0.006) UNVA. No moderate or severe adverse events were reported in either group.

Conclusions:

This clinical trial demonstrates that PresbiDrops is a safe, tolerable and effective treatment for presbyopia. This viable alternative to reading glasses and surgery provided a meaningful improvement in near vision for approximately one third of subjects treated.