Aldeyra Therapeutics has announced positive results from the Phase 3 ALLEVIATE Trial of reproxalap topical ophthalmic solution in patients with allergic conjunctivitis.

"This confirms the potential of reproxalap as a novel and clinically meaningful approach for treatment of allergic conjunctivitis,” said Aldeyra CEO Todd Brady. “Given that approximately half of allergic conjunctivitis patients also suffer from ocular dryness, we believe the ALLEVIATE results highlight the relevance of reproxalap to our current Phase 3 programme in dry eye disease."

Reproxalap exhibited an anti-inflammatory profile that is distinct from standard-of-care antihistamine therapy and supported a differentiated mechanism of action for the treatment of allergic conjunctivitis, the company said.

The double-masked, randomised, vehicle-controlled, multi-center, parallel-group conjunctival allergen challenge trial assessed the efficacy and safety of 0.25% and 0.5% reproxalap topical ophthalmic solutions compared to vehicle in 318 patients with seasonal allergic conjunctivitis. Patients treated with 0.25% and 0.5% reproxalap demonstrated statistically significant reduction in ocular itching. There were no observed safety or tolerability concerns and no observed adverse events other than mild and transient instillation site irritation.

"There is a large allergic conjunctivitis patient population that is under-served by currently available medications," Aldeyra chief medical officer, Dr David Clark, said. "Results suggest the potential of topical ocular reproxalap as a novel, safe, and effective therapeutic option that could be used to complement existing therapy before resorting to corticosteroids, which can lead to serious ocular toxicity."

In the second half of this year, Aldeyra said, it planned to meet with regulatory authorities to discuss the ALLEVIATE results and remaining clinical requirements for a potential submission of a new drug application to the US Food and Drug Administration.