Reproxalap meets all endpoints in phase 3 allergic conjunctivitis trial
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Key takeaways:
- Ocular itching and ocular redness decreased after treatment with reproxalap.
- All endpoints were met in the phase 3 INVIGORATE-2 clinical trial.
Reproxalap for the treatment of allergic conjunctivitis achieved the primary and secondary endpoints in the phase 3 INVIGORATE-2 clinical trial, according to a press release from Aldeyra Therapeutics.
The randomized, double-masked, vehicle-controlled trial included 131 patients with allergic conjunctivitis, with the primary efficacy endpoint being the change from baseline in patient-reported ocular itching score on a 0- to 4-point scale over a majority of 11 time points from 110 to 210 minutes after allergen chamber entry, the release said. The key secondary endpoint was the change from baseline in ocular redness on a 0- to 4-point scale over the 3.5 hours of the duration of the allergen chamber.
Patients treated with 0.25% reproxalap ophthalmic solution experienced a statistically significant reduction in ocular itching score from baseline across all 11 prespecified time points (P < .0001 for all) as well as a statistically significant reduction in ocular redness over the duration of the allergen chamber (P = .004) compared with those treated with vehicle.
Two additional secondary endpoints were also met: change from baseline in ocular tearing score on a 0- to 3-point scale (P < .0001) and change from baseline in total ocular severity score (P < .0001).
There were no reported safety or tolerability concerns in the trial.
“Consistent with the results of the phase 3 INVIGORATE trial and in conjunction with a number of successful phase 2 and phase 3 clinical trials in dry eye disease, achievement of the primary endpoint and all secondary endpoints in INVIGORATE-2 supports the potential of reproxalap as a treatment for inflammatory diseases of the ocular surface,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release.
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