Allergy

Ora’s world-class allergy models and allergy methodologies have grown directly out of the breakthrough allergy research work our founder, Dr. Mark Abelson, first completed at Schepens Eye Research Institute (SERI). This work focused on the identification of histamine receptors and the role of pro-inflammatory mediators in the eye and his development of animal and human models for screening potential anti-allergic agents.

Today, Ora's validated model for conducting allergy studies, The Conjunctival Allergen Challenge (CAC™) is recognized as the gold standard for conducting topical ophthalmic pharmaceutical studies for allergy medications by regulatory authorities in the US, Europe and Japan.  In fact, the last 17 allergy eye drops that have been brought to market have all been approved through the use of the CAC™ model.

Through its Research on Research approach, Ora has also developed the hybrid Enviro-CAC™ model that incorporates key features of both the CAC model and the environmental model. The screening process in the Enviro-CAC™ model identifies subjects with an ongoing chronic allergic response who also respond positively to the acute allergen challenge of the CAC™ model.

The Ora Allergy department has conducted dozens of Phase I through IV allergy trials, and our research staff has extensive experience in comfort, safety and pharmacokinetic studies. We are also experienced in performing technical procedures including ECGs, X-rays, TB testing, and physical exams, and have participated in trials to evaluate both biologics and drugs administered by intravenous, subcutaneous, oral, and topical routes.

Ora’s allergy department consists of an experienced, professional research staff including board-certified ophthalmologists, RNs, and clinical research associates (CRAs). We are available to consult on the development of protocols, including safety and efficacy endpoints, visit schedules, dosing schedules, study population size and number of sites required, clinical relevance, quality-of-life, market positioning, and adverse event management.

Many of our clients look to us to first conduct pilot studies, and then help them to rapidly expand into larger multi-center trials.  We also provide site management, recruitment strategies, monitoring, and bioinformatics services.

For more information, please contact Paul Gomes, Director of Allergy, at (978) 685-8900, ext. 9429 or by email at pgomes@oraclinical.com.