- Recently Announced Phase 3 INVIGORATE Clinical Trial Results Indicated Statistically Significant Activity of Reproxalap in Ocular Itching and Redness Associated with Allergic Conjunctivitis
- Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Trials of Reproxalap in Dry Eye Disease Expected in the Second Half of 2021
- Initial Phase 2 Clinical Trial Results for ADX-629, a Novel Orally Available Systems-Based RASP Inhibitor with Potential Broad Applicability Across Immune-Mediated Diseases, Expected in the Second Half of 2021
- Raised Gross Proceeds of $125 Million Before Deduction of Underwriting Discounts and Commissions, in Underwritten Public Offering
- Projected Cash Runway Through 2023, Including Potential New Drug Applications; Initial Commercialization of Reproxalap, if Approved; and Continued Pipeline Development
- Management to Host Conference Call at 8:00 a.m. ET Today
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today reported financial results for the quarter ended March 31, 2021 and provided recent business highlights.
“We expect 2021 to be a catalyst-rich year for Aldeyra as we continue to advance reproxalap, our lead program, toward potential commercialization in anterior ocular inflammatory disease,” stated President and CEO Todd C. Brady, M.D., Ph.D. “We recently completed the Phase 3 INVIGORATE Trial of reproxalap, achieving statistically significant superiority over vehicle across all assessed signs and symptoms of allergic conjunctivitis, including ocular itching and redness. We look forward to meeting with the U.S. Food and Drug Administration in the second half of this year to discuss the INVIGORATE results and the potential submission of a New Drug Application (NDA). In addition, we remain on track to report top-line results in the second half of this year from the Phase 3 TRANQUILITY and TRANQUILITY-2 clinical trials of reproxalap in dry eye disease.
“We believe we continue to operate from a position of financial strength,” Dr. Brady stated. “With the recent follow-on public offering, we expect to have sufficient capital to prepare reproxalap for NDA submission and a potential commercial launch, if approved, while investing in the clinical development of ADX-629, ADX-2191, and other product candidates in retinal and systemic immunological diseases with unmet medical need.”
Recent Highlights and Program Updates
- Primary, Key Secondary, and All Secondary Endpoints Met in Phase 3 INVIGORATE Allergic Conjunctivitis Clinical Trial: In the first-ever Phase 3 clinical trial of a novel investigational product in an allergen chamber, 0.25% reproxalap ophthalmic solution (reproxalap) demonstrated statistically significant improvement over vehicle for the primary endpoint of ocular itching (p