The model specifically for drugs that target the inflammatory component of ongoing persistent allergic reactions.
Ora ensures that the proper protocol design from its family of allergy clinical models is selected to match the mechanism of action of the drug. We have clinical models that are specific to early phase allergic reactions, late phase, inflammation, perennial allergy, and other activity of the ocular surface when combined with our dry eye models.
We have specifically designed the Enviro-CAC™ for drugs that target the inflammatory component of ongoing persistent allergic reactions. We operate this using the same key operational and technical aspects of Ora’s proven systems.
The key disadvantage to traditional environmental studies is the lack of proper selection of the appropriate subgroups. Additionally, larger studies span across multiple seasons and there's an inability to identify proper patients through solely IgE blood tests or skin testing. In the Ora Enviro-CAC,™ the CAC is used to screen for a refined sub-group of patients that are a responsive to the specific allergen in season, or specific patient sub-population that is chosen for the protocol. This ensures those patients do, in fact, have allergic conjunctivitis (or allergic rhinoconjunctivitis, as may be defined in the protocol) to the proper allergen. This enables us to screen for an enriched population.
We can also select patients that show drug effect with a current therapy, or patients that are non-responsive to current treatment, and identify patients that “break through.”
The inclusion of the screening CAC, and the proper patient selection based on defined response to current therapy, allows for a precise subgroup of patients to be enrolled, increasing the control and likelihood of success compared to a traditional environmental study. This helps drive treatment effect and ability to show response.