Aldeyra Therapeutics, a clinical-stage biotechnology company devoted to treating inflammation and inborn errors of metabolism, today announced that it has enrolled the first patient in a Phase 2b clinical trial of topical ocular reproxalap for the treatment of dry eye disease (DED).
"Existing therapy for dry eye disease, a common inflammatory condition that leads to persistently disturbing ocular irritation, is generally considered by physicians and patients to be inadequate, but represents one of the largest ophthalmic markets worldwide," commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "Based on the positive results from the Phase 2a dry eye disease clinical trial with our topical ocular product candidate reproxalap announced in September 2017, we are pleased to begin enrolling our Phase 2b clinical trial, and expect to report results in the second half of this year."
Reproxalap and other product candidates generated from Aldeyra's aldehyde trap platform sequester and facilitate the degradation of pro-inflammatory aldehyde mediators, a class of small molecule therapeutic targets that are elevated in DED patients. The Phase 2b clinical trial will test two concentrations of topical reproxalap (0.1% and 0.25%) against vehicle over 12 weeks of treatment in 300 patients with moderate dry eye disease. Consistent with the Phase 2a clinical trial, endpoints will include standard signs and symptoms characteristic of DED.
A clinical trial synopsis can be found on clinicaltrials.gov (#NCT03404115).
About Aldeyra Therapeutics
Aldeyra Therapeutics, Inc. is a biotechnology company devoted to improving lives by inventing, developing, and commercializing products that treat inflammation and inborn errors of metabolism. Aldeyra's lead product candidate, reproxalap (formerly known as ADX-102), is a small molecule aldehyde sequestering agent in Phase 2b clinical development for the treatment of dry eye disease, and Phase 3 clinical development for the treatment of allergic conjunctivitis, noninfectious anterior uveitis, and Sjögren-Larsson Syndrome. Reproxalap has not been approved for sale in the U.S. or elsewhere.
About Dry Eye Disease
Dry eye disease is a common and chronic inflammatory disease estimated to affect approximately 20 million people in the United States, and is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, and, in severe cases, decreased vision. Among physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate. In patients with dry eye disease, pro-inflammatory aldehyde mediators may contribute to ocular inflammation. By diminishing aldehyde levels, Aldeyra's topical ocular aldehyde trap platform represents a novel and differentiated approach for the treatment 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 plans and expectations for the development of reproxalap; and the potential of reproxalap as an agent for the treatment of dry eye disease. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ mater...
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