Aldeyra Therapeutics announced the last patient dosing for its Phase 2b clinical trial of ADX-102 in allergic conjunctivitis.
Aldeyra Therapeutics (NASDAQ:ALDX) announced the last patient dosing for its Phase 2b clinical trial of ADX-102 in allergic conjunctivitis.
As quoted in the press release:
Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, commented, “We are excited to complete enrollment and dosing of patients in our allergic conjunctivitis Phase 2b clinical trial. The ability to enroll 150 patients in just over two months speaks to the prevalence of allergic conjunctivitis, which may affect up to 20% of the population worldwide. For the approximately one million patients in the United States who do not respond to or cannot tolerate currently available medications, ADX-102 could represent a new and compelling therapeutic option.”
In accordance with discussions with the United States Food and Drug Administration, the Phase 2b clinical trial tested 0.1% and 0.5% concentrations of topical ocular ADX-102 against saline. Each of the three groups in the trial was comprised of 50 patients with a history of allergic conjunctivitis. Consistent with clinical trials used for registration of other drugs in allergic conjunctivitis, patients in the Phase 2b trial were treated with a single dose of drug or saline in both eyes, followed by challenge with topically administered allergen. Patient-reported ocular itching will be assessed as the primary endpoint.
In 2016, Aldeyra announced that topical ocular 0.5% ADX-102 demonstrated statistically superior reductions from drug vehicle in ocular itching following allergen challenge in a Phase 2a clinical trial.
About Aldeyra Therapeutics
Aldeyra Therapeutics, Inc. is a biotechnology company devoted to improving lives by inventing, developing and commercializing products that treat diseases thought to be related to endogenous aldehydes, a naturally occurring class of pro-inflammatory and toxic molecules. Aldeyra’s lead product candidate, ADX-102, is an aldehyde trap in development for ocular inflammation, as well as for Sjögren-Larsson Syndrome and Succinic Semi-Aldehyde Dehydrogenase Deficiency, two inborn errors of aldehyde metabolism. ADX-102 has not been approved for sale in the U.S. or elsewhere.
Allergic conjunctivitis is a common allergic disease that is thought to be mediated in part by pro-inflammatory aldehydes, and 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.