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. Full results from the study will be submitted for presentation at an upcoming medical meeting.
“The successful completion of the phase 2b study is a significant milestone for Orasis. We are encouraged by these results and CSF-1’s potential to improve the quality of life for people with presbyopia,” Elad Kedar, chief executive officer of Orasis, said in a company news release. “CSF-1 can potentially alleviate the burden of reading glasses and offer a meaningful solution for billions of people living with age-related farsightedness worldwide.”
“We are pleased with CSF-1’s clinical performance in our Phase 2b study, as demonstrated by the positive efficacy, safety and tolerability results,” Ron Neumann, MD, chief medical officer of Orasis, said in the news release. “We look forward to presenting additional details at an upcoming ophthalmology meeting. In the meantime, we are moving forward as quickly as possible with our preparation for phase 3.”
The phase 2b study (NCT03885011) was a multicenter, double-masked clinical trial that evaluated the efficacy and safety of CSF-1 in 166 participants across several research centers in the U.S. For more details about the study, please visit ClinicalTrial.gov.