Ora Inc., a global, full-service ophthalmic clinical research and product development firm, announced that its Conjunctival Allergen Challenge (Ora-CAC®) model recently confirmed Phase 2 clinical results of Sustained Release Dexamethasone (OTX-DP), a drug-eluting intracanalicular depot, under development by Ocular Therapeutix (Nasdaq: OCUL) as DEXTENZA, for the treatment of chronic allergic conjunctivitis. DEXTENZA achieved 1-unit difference from vehicle in ocular itching, which has previously been the FDA standard for approval of therapies in this disease.
“It is thrilling to see the intersection of Ocular Therapeutix’s innovative approach and Ora’s proven scientific precision advancing this important new treatment for patients with chronic allergy.”
For more information about the results of Ocular’s Phase 3 trial, which were announced on October 22, 2015, please visit the Ocular Therapeutix website at www.ocutx.com.
For three decades, Ora has been the leader in ocular allergy, both through environmental studies and through its various precise and reproducible models. The current Ora-CAC®, accepted and implemented worldwide, has been validated through the real-world usage of its 20 approved anti-allergy products that have improved the quality of life of millions of allergy sufferers. Utilizing the Ora-CAC®, the anti-allergic efficacy of DEXTENZA has been amply demonstrated.
“Ora’s technology and operational approach deliver much needed precision and consistency to the drug development process,” commented Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix. “We are pleased that our most recent Ora-CAC model Phase 3 study replicated key endpoints of the Phase 2 study, giving us confidence as we proceed with the final stages of development of this exciting product, which fulfills a significant unmet need in chronic allergy.”
Allergic conjunctivitis affects 50-130 million people in the U.S. with severe and chronic allergy estimated to impact nearly 40% of this population. These patients experience an inflammatory allergic disease that is not sufficiently treated with antihistamines or mast cell stabilizers alone.
“Ocular Therapeutix’s DEXTENZA product candidate succeeded in realizing the 1-unit standard of clinical significance in ocular itching out to 30 days, a record achievement for an ocular allergy drug,” said Stuart Abelson, President & CEO of Ora, Inc. “It is thrilling to see the intersection of Ocular Therapeutix’s innovative approach and Ora’s proven scientific precision advancing this important new treatment for patients with chronic allergy.”
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 allergic conjunctivitis, and Phase 2 clinical development for glaucoma and inflammatory dry eye. 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 40 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 in the US and internationally across all indications. 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.
Stephanie Roy, 978-685-8900