Orasis Pharmaceuticals completes phase 3 trials for presbyopia candidate

Orasis Pharmaceuticals has concluded its NEAR-1 and Near-2 phase 3 clinical trials, the company announced Tuesday.

The multi-center, double-masked, parallel-group clinical trials enrolled over 600 patients ages 45 to 64 across the U.S. in order to evaluate the safety and efficacy of CSF-1, a corrective eye drop candidate for the treatment of presbyopia, according to a news release.

CSF-1, a preservative-free solution containing a proprietary combination of low-dose pilocarpine and multi-faceted vehicle, is designed as an alternative to reading glasses for patients.¹

Per the company, trial results thus far have demonstrated significant improvements in near vision and a superior safety profile.

In a phase 2b study, CSF-1 showed exceptional near visual acuity with no reduction of distance or night vision.¹

Additionally, the phase 2b study met its primary end-point, 2-line improvement in near vision (based on the standard ETDRS chart).¹

“Completion of this clinical trial milestone is exciting because it puts Orasis in position to be next in market," said Orasis CEO Elad Kedar, in a statement. "We look forward to sharing topline results in the coming months and advancing CSF-1 toward commercialization.”

References

1. Orasis Pharmaceuticals. CSF-1 overview. Accessed March 15, 2022. https://www.orasis-pharma.com/our-solution/csf-1-overview/