Aldeyra's Reproxalap Hits Primary Goals In Dry Eye Disease Chamber Crossover Trial

  • Aldeyra Therapeutics Inc ALDX achieved the primary endpoints in a crossover clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate for dry eye disease. 
  • Relative to the vehicle, a statistically significant reduction in ocular redness was observed following treatment with reproxalap as soon as 10 minutes after dry eye chamber entry.
  • The Schirmer test, assessed approximately 10 minutes before and after the fourth dose of reproxalap or vehicle, was statistically significant in favor of reproxalap at both time points.
  • Also Read: Why Aldeyra Therapeutics' Shares Are Soaring Today?
  •  No safety signals were observed in the trial, and reproxalap was well tolerated; there were no treatment-emergent moderate or serious adverse events. 
  • Three patients were discontinued due to adverse events, two during vehicle administration and one during reproxalap administration. Reproxalap has now been studied in over 1,800 patients. 
  • A pre-NDA meeting with the FDA has been scheduled for Q3 of 2022. 
  • Price Action: ALDX shares are up 6.26% at $4.75 during the premarket session on the last check Tuesday.
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