Orasis Pharmaceuticals completes phase 3 trials for presbyopia candidate

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CSF-1 is a preservative-free solution designed as an alternative to reading glasses for patients.


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/