Orasis reports positive results for eye drop to treat presbyopia
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Orasis Pharmaceuticals announced that its phase 3 trials showed patients treated with CSF-1 achieved a statistically significant three-line or more gain in distance-corrected near visual acuity with no loss of distance visual acuity.
The data from the NEAR-1 and NEAR-2 trials, which involved 613 subjects, will be the basis for U.S. regulatory submission in the second half of 2022, the company said in a press release.
CSF-1, a 0.4% pilocarpine HCl solution, met its primary and key secondary endpoints on day 8, according to the release. Pooled across the two studies, 40% and 50% of subjects showed these gains 1 hour after dose 1 and 1 hour after dose 2, respectively. The three-line improvement was seen at all measured time points on days 1 and 15, and on day 15, subjects achieved it as early as 20 minutes and up to 8 hours after dosing.
The company said the therapeutic showed an “excellent” tolerability and safety profile, with redness and comfort comparable to vehicle. The most common adverse event was headache and instillation sight pain in 6.8% and 5.8% of subjects, respectively.
Orasis CEO Elad Kedar said in the release that these positive results “position us well to be the next product launch in this category.”
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