Three hundred patients with dry eye disease were randomized equally to receive 0.1%, 0.25%, or vehicle for 12 weeks. The primary objective of the trial was to evaluate the safety and efficacy of reproxalap for the treatment of the symptoms and signs of dry eye disease in order to select a drug concentration, confirm endpoint selection, and determine sample size for a pivotal Phase 3 clinical program.
“Based on the successful Phase 2b results, we look forward to initiating a Phase 3 program in dry eye disease in 2019 following our discussion with regulatory authorities,” commented Todd C. Brady, M.D., Ph.D., Chief Executive Officer of Aldeyra. “The addition of dry eye disease to our late-stage clinical portfolio, which includes Phase 3 clinical trials in allergic conjunctivitis and noninfectious anterior uveitis, highlights the potential of reproxalap as a highly differentiated and novel ophthalmic therapy.”
Conference Call
Aldeyra will hold a conference call on September 26, 2018 at 8:00 a.m. ET to discuss results of the clinical trial. Thedial-in numbers are1-877-266-8979 for domestic callers and1-412-317-5231 for international callers. A live webcast of the conference call will also be available on the investor relations page of Aldeyra’s corporate website at ir.aldeyra.com. After the live webcast, the event will remain archived on Aldeyra’s website for one year.
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead product candidate, reproxalap, is afirst-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. Aldeyra is also developing other product candidates for autoimmune disease, post-transplant lymphoproliferative disease, retinal inflammation, metabolic disease, and cancer. None of Aldeyra’s product candidates have been approved for sale in the U.S. or elsewhere.
About Dry Eye Disease
Dry eye disease is a common inflammatory disease estimated to affect approximately 20 million people in the United States. The disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, diminished quality of life, and in severe cases, permanent vision impairment. Among physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate. In patients with dry eye disease,pro-inflammatory RASP (Reactive Aldehyde Species) may contribute to ocular inflammation. By diminishing RASP levels, Aldeyra’s RASP inhibitor platform represents a novel and differentiated approach for the treatment of the symptoms and signs of dry eye disease.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra’s strategy, future operations, future, prospects, plans, and objectives and Aldeyra’s plans and expectations for