Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease
Following discussions with the FDA, Aldeyra intends to initiate a dry eye chamber clinical trial in the first half of 2024.
- Following discussions with the FDA, Aldeyra intends to initiate a dry eye chamber clinical trial in the first half of 2024.
- In the proposed dry eye chamber trial, patients will be administered vehicle (the drug product without the active ingredient) before and during exposure to a dry eye chamber.
- The design and statistical powering for the proposed trial are derived from four previously completed dry eye chamber clinical trials with reproxalap.
- ET today, March 28, 2024, to discuss the clinical development plan for resubmission of the new drug application for reproxalap in dry eye disease.