Aldeyra’s Reproxalap Demonstrates Efficacy in Reducing Eye Discomfort in New Phase 3 Study

Primary Endpoint Achievement:
Aldeyra Therapeutics' reproxalap has achieved the primary endpoint in a new Phase 3 study, showing statistical superiority over the vehicle in reducing ocular discomfort (P=0.004).

FDA Rejection:
Despite this success, reproxalap was previously rejected by the FDA due to insufficient clinical evidence demonstrating efficacy in treating ocular symptoms associated with dry eye disease.

New Trial Plans:
Aldeyra plans to conduct another trial to address the FDA's concerns, aiming to submit a new drug application (NDA) in the first half of 2024.

Previous Trials:
Previous Phase 3 trials, including TRANQUILITY and TRANQUILITY-2, showed mixed results, with reproxalap improving tear production but missing the primary endpoint of ocular redness.

Financial Position:
Aldeyra has $143 million in cash and cash equivalents, which is sufficient to fund the new trial expected to cost less than $2 million.

Future Indications:
Aldeyra is also developing reproxalap for conjunctivitis and plans to discuss a new drug filing for this indication with the FDA in the first half of 2024.