Clinical trial on Noninfectious Anterior Uveitis – SBECD offering disease resolution

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Aldeyra Therapeutics Announced Results from the SOLACE Trial in Noninfectious Anterior Uveitis. The main points are:
  • Statistical Significance Not Achieved for Primary or Secondary Endpoints Due to High Rates of Disease Resolution in Vehicle-Treated Patients, but Activity of Reproxalap Observed to be Consistently Greater than Vehicle
  • Noninfectious Anterior Uveitis Program to be Discontinued
  • Company Plans to Prioritize Phase 3 Ocular Pipeline Programs in Dry Eye Disease, Allergic Conjunctivitis, and Proliferative Vitreoretinopathy

Whereas, the results are obviously disappointing for Aldeyra Therapeutics, Inc., a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, it is interesting to look into the reason of the failure: statistical significance not achieved for the primary or secondary endpoints, due to high rates of disease resolution in vehicle-treated patients, but activity of reproxalap was consistently greater than that of vehicle.

In this particular formulation, the vehicle is a cyclodextrins, Betadex Sulfobutyl Ether Sodium (SBECD, Dexolve, Captisol). Which is technically another discovery for potential applicability of cyclodextrins as actives. Of course the mechamism of action is far from clarified in this case.


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