Abstract
Purpose :
To assess the safety, tolerability and efficacy of a pharmaceutical treatment for presbyopia (CSF-1, Orasis Pharmaceuticals, Herzliya, Israel) in normal subjects.
Methods :
A phase 2a, multicenter double-masked randomized placebo-controlled repeated administration, crossover study on 36 subjects (14 males, 22 females, age 44-62 years, distance refraction ≤1D along any principal meridian). Subjects were randomized in a 1:1 ratio to one of two treatment arms: CSF-1, and placebo. The subjects self-administered the treatment, a single drop in each eye, for two weeks. Following a 24-hour washout interval, a crossover was performed: those initially treated with CSF-1, received placebo and vice versa.
Results :
Efficacy, defined as the percentage of participants demonstrating ≥ 2-line improvement from baseline in binocular uncorrected near visual acuity (UNVA), the rate of a two-line improvement was significantly higher with CSF-1, as compared to placebo, under both high illumination (41.7% versus 22.2%, respectively, p=0.04) as well as low illumination (41.7% versus 16.7% respectively, p=0.006) UNVA. No moderate or severe adverse events occurred in either group.
Conclusions :
CSF-1, is a safe, tolerable and effective treatment for presbyopia. This alternative to reading glasses, and surgery, provided a meaningful improvement in the near visual acuity in over 40% of cases without undesirable effects on distance visual acuity.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.