LEXINGTON, MA, USA I April 24, 2018 I Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with inflammatory diseases, today announced that it has enrolled the first patient in a Phase 3 clinical trial of topical ocular reproxalap for the treatment of allergic conjunctivitis.
“We are pleased to advance our allergic conjunctivitis program to Phase 3 clinical testing,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “With clinically demonstrated post-histaminic activity, reproxalap could represent the first mechanistically differentiated product in decades for the treatment of allergic conjunctivitis, a chronic disease that affects approximately 100 million patients in the United States. We look forward to presenting the results of the trial in the second half of 2018 or early 2019.”
The multi-center, double-masked, parallel-group, vehicle-controlled Phase 3 clinical trial is expected to enroll 300 allergic conjunctivitis patients, randomized equally to receive either topical ocular 0.25% reproxalap, 0.5% reproxalap, or vehicle in a conjunctival allergen challenge model of acute allergic conjunctivitis. The primary outcome measure will be patient-reported ocular itching.
A clinical trial synopsis can be found on clinicaltrials.gov (#NCT03494504).
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with inflammatory diseases. Aldeyra’s lead product candidate, reproxalap, is a first-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. Aldeyra is leveraging its experience in ocular inflammation to develop other product candidates for systemic inflammatory disease. None of Aldeyra’s product candidates have been approved for sale in the U.S. or elsewhere.
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that affects 20% or more of the population worldwide. The disease is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye), resulting in ocular itching, excessive tear production, lid swelling, and redness. Antihistamines are commonly used to treat allergic conjunctivitis, but use is limited by lack of durable activity and ocular dryness.
SOURCE: Aldeyra Therapeutics
Post Views: 130
LEXINGTON, MA, USA I April 24, 2018 I Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with inflammatory diseases, today announced that it has enrolled the first patient in a Phase 3 clinical trial of topical ocular reproxalap for the treatment of allergic conjunctivitis.
“We are pleased to advance our allergic conjunctivitis program to Phase 3 clinical testing,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “With clinically demonstrated post-histaminic activity, reproxalap could represent the first mechanistically differentiated product in decades for the treatment of allergic conjunctivitis, a chronic disease that affects approximately 100 million patients in the United States. We look forward to presenting the results of the trial in the second half of 2018 or early 2019.”
The multi-center, double-masked, parallel-group, vehicle-controlled Phase 3 clinical trial is expected to enroll 300 allergic conjunctivitis patients, randomized equally to receive either topical ocular 0.25% reproxalap, 0.5% reproxalap, or vehicle in a conjunctival allergen challenge model of acute allergic conjunctivitis. The primary outcome measure will be patient-reported ocular itching.
A clinical trial synopsis can be found on clinicaltrials.gov (#NCT03494504).
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with inflammatory diseases. Aldeyra’s lead product candidate, reproxalap, is a first-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. Aldeyra is leveraging its experience in ocular inflammation to develop other product candidates for systemic inflammatory disease. None of Aldeyra’s product candidates have been approved for sale in the U.S. or elsewhere.
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that affects 20% or more of the population worldwide. The disease is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye), resulting in ocular itching, excessive tear production, lid swelling, and redness. Antihistamines are commonly used to treat allergic conjunctivitis, but use is limited by lack of durable activity and ocular dryness.
SOURCE: Aldeyra Therapeutics
Post Views: 130
