Orasis Pharmaceuticals Announces Successful Phase IIb Results

Orasis Pharmaceuticals announced its CSF-1 eye drop has successfully met the primary endpoint in a phase 2b clinical study in individuals with presbyopia. CSF-1 successfully demonstrated statistically significant improvement in distance-corrected near visual acuity of a 3-line or greater gain. In addition, CSF-1 demonstrated an exceptional safety and tolerability profile. 

Orasis Announces Initiation of Phase 2b Clinical Study of CSF-1 for the Treatment of Presbyopia

“We are excited to initiate the Phase 2b clinical trial evaluating our corrective eye drop as it marks a key milestone in its clinical development,” said Elad Kedar, chief executive officer of Orasis. “CSF-1 has the potential to restore near-vison and offer an alternative to current treatment options, which are either cumbersome or invasive. We look forward to sharing the results from this study in the near future as we advance the development of CSF-1 in the clinic for the treatment of presbyopia, a condition that affects more than 1.8 billion people worldwide.”

The Phase 2b study (NCT03885011) is a multi-center, double-masked trial in the U.S. enrolling 150 participants with presbyopia to evaluate the efficacy and safety of CSF-1. The study started enrolling patients in February 2019. All study sites are actively recruiting participants aged 45 to 64 with presbyopia.