Ora Inc., a global, full-service ophthalmic clinical research and product development firm, announced that its Conjunctival Allergen Challenge (Ora-CAC®) model provided a platform for the successful Phase 2 clinical results of Sustained Release Dexamethasone (OTX-DP), a drug-eluting punctum plug, that is being evaluated by Ocular Therapeutix (Nasdaq: OCUL) for the treatment of allergic conjunctivitis. To accommodate for the anti-inflammatory effect of a one-time administered sustained release drug product, Ocular Therapeutix used a modified version of the Ora Conjunctival Allergen Challenge (Ora-CAC®) model, developed by Ora, Inc. For more information about the results of Ocular’s Phase 2 trial, which were announced on November 12, 2014, please visit the Ocular Therapeutix website at www.ocutx.com.
“Over the past 30 years, the Ora-CAC® has been used to evaluate every anti-allergic agent available today for the treatment of allergic conjunctivitis, and for the majority of these, were the pivotal studies for FDA approval of the drug,” commented Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix. “The recently completed Phase 2 trial provided us with valuable insight into the advantages of utilizing a modified Ora-CAC® model, which we will incorporate into future trial design.”
The Ora-CAC® clinical model has been used as the basis for approval of 19 anti-allergy products, including the three most recent approvals Lastacaft™, Bepreve™, and Pataday®, providing a safe, reproducible method of evaluating anti-allergic ophthalmic agents. As the incidence of late phase allergic conjunctivitis has been increasingly recognized over the past decade, internal research and development efforts at Ora have focused on modifying the Ora-CAC® to develop a clinical technology that elicits patient responses which are more indicative of the late phase of allergic conjunctivitis to better evaluate anti-inflammatory agents.
Allergic conjunctivitis affects 50-130 million people in the U.S. and the more severe form is estimated to impact nearly 30% of this population. These patients experience a more severe, late-phase allergic manifestation and are not sufficiently treated with antihistamines or mast cell stabilizers alone. They frequently develop chronic ocular surface inflammation due to repeated allergic insult and infiltration of inflammatory cells and many progress towards dry eye. The modified version of the Ora-CAC® used in this study provides an efficient and predictable way to study this type of allergic conjunctivitis.
“It’s a privilege to be working with such an innovative company such as Ocular Therapeutix and its management team who understand the value that our models and technologies bring to the development process,” said Stuart Abelson, President & CEO of Ora, Inc. “Ocular Therapeutix’s innovative therapies, coupled with our expertise in allergy, has resulted in a highly successful collaboration thus far. We are excited about the opportunity to advance the clinical development of Sustained Release Dexamethasone together.”
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidates are in Phase 3 clinical development for post-surgical ocular inflammation and pain, and Phase 2 clinical development for glaucoma and allergic conjunctivitis. The Company is also evaluating sustained-release injectable anti-VEGF drug depots for back-of-the-eye diseases. Ocular Therapeutix’s first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.
Ora, Inc. is a global, full-service ophthalmic clinical research and product development firm. Over the past 30 years, it has helped clients earn 37 FDA approvals. Ora supports a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently and successfully bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects both in the US and internationally. Ora brings together the world’s most extensive and experienced network of ophthalmic experts and R&D professionals in order to maximize the value of new product initiatives. For additional information, please visit https://oraclinicalwp.wpengine.com.
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Amy Phillips, 412-327-9499