Phase 2 trial underway to investigate Nyxol, pilocarpine for presbyopia
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Ocuphire Pharma has enrolled the first patients in a phase 2 proof of concept trial evaluating a combination of Nyxol and pilocarpine for the treatment of presbyopia, according to a press release.
VEGA-1 is a double-masked, randomized, placebo-controlled multicenter trial evaluating 0.75% Nyxol (phentolamine mesylate) in combination with 0.4% pilocarpine. The trial is aiming to include 152 patients with a clinical diagnosis of presbyopia.
“We believe that the combination of Nyxol and low-dose pilocarpine has an ideal product profile to become a promising treatment for presbyopia,” Mina Sooch, MBA, president and CEO of Ocuphire, said in the release.
The primary endpoint of the study is the percentage of patients with three or more lines of binocular distance corrected near visual acuity (DCNVA) improvement on a near vision eye chart in day lighting, the release said. Secondary endpoints include DCNVA improvement at three lines without loss of distance vision, improvement in pupil diameter and improvement in DCNVA at one and two lines compared with placebo, Nyxol alone and low-dose pilocarpine alone.
Ocuphire expects to report topline data at the end of the second quarter.
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