Phase 3 reproxalap trial meets ocular discomfort endpoint in patients with dry eye
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Key takeaways:
- Reproxalap was statistically superior to vehicle in reducing ocular discomfort.
- Aldeyra plans to resubmit a new drug application for reproxalap this year.
Patients with dry eye disease experienced improvements in ocular discomfort after treatment with reproxalap, according to a press release from Aldeyra Therapeutics.
“We are pleased with the results as the primary endpoint was definitively achieved with a P value of .004,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, told Healio.
In a phase 3 randomized, double-masked, vehicle-controlled clinical trial investigating 0.25% reproxalap ophthalmic solution, 66 patients received reproxalap and 66 patients received vehicle before and during exposure to a dry eye chamber.
The study met its primary endpoint of ocular discomfort from 80 to 100 minutes in the chamber, with reproxalap statistically superior to vehicle in reducing discomfort (P = .004).
“Notably, ocular discomfort change from baseline was numerically lower for the group of patients who received reproxalap at every time point in the dry eye chamber,” Brady said. “The potential inclusion of the data in the label allows for powerful differentiation of reproxalap relative to standard of care given the acute onset of activity that, in the chamber, is measured in minutes vs. weeks or months for all commercially available dry eye disease therapies.”
Reproxalap was well tolerated, with no safety signals observed in the trial.
Aldeyra plans to resubmit a new drug application for reproxalap to the FDA this year, with an expected review period of 6 months.
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