Ora CEO Addresses Complexities of Dry Eye Clinical Research at TFOS Conference in Florence, Italy

ANDOVER, MA--(Marketwire - October 12, 2010) -

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Ora, Inc.

During the 6th International Conference on the Tear Film & Ocular Surface: Basic Science and Clinical Relevance (TFOS) Conference, Stuart B. Abelson, President and CEO of Ora, Inc., shared Ora's perspectives on the many clinical research challenges associated with the development of Dry Eye therapies. Mr. Abelson spoke as part of the TFOS Expert's Meeting, "Global Treatments for Dry Eye Syndrome: An Unmet Need," which was a pre-cursor to the official start of TFOS. The TFOS Conference took place in Florence, Italy on September 22-25, 2010.

"Ora has been at the leading edge of Dry Eye research for 15 years because of the work led by our Director of Dry Eye, George Ousler," explained Mr. Abelson. "At Ora, we believe that if you've studied a drug correctly and gained robust clinical data, regulatory challenges become less significant. Reciprocally, if the clinical data is inadequate, regulatory hurdles will be insurmountable. For this reason, we always take a process-driven approach to overcoming regulatory challenges through better science."

"Because Ora has more experience in Dry Eye research than any other firm, we have been able to develop a comprehensive Dry Eye Research System that has been developed through years of refinements to our models and methods. We are able to leverage our Dry Eye subject database to select the most appropriate sub-groups for the most efficient development of the dry eye drugs. That is why more and more promising dry eye therapies are being evaluated and tested with outstanding efficiency and safety standards through Ora's Controlled Adverse Environment (CAE™) model," Mr. Abelson added.

While at the TFOS Conference, Ora presented three Dry Eye research posters. The first poster, "Screening Model for Novel Therapeutics For Dry Eye Syndrome In A Non-Human Primate," focused on the preclinical Dry Eye research work that Ora is currently conducting on African Green monkeys with their preclinical strategic partner RxGen, based on the Caribbean island of St. Kitts. The second poster, "The Enhanced Controlled Adverse Environment II (CAE™) System Increases Within-Subject Reliability," demonstrated the validity, repeatability and reproducibility of the CAE™ model. The third poster, "Comparison Of Dry Eye Patient Signs In Environment Conditions To Static And Mobile Dry Controlled Adverse Environment (CAE™) Models," compared the appearance of keratitis in the Controlled Adverse Environment (CAE™) to keratitis in dry eye subjects not exposed to the CAE™, to ensure that the physiological appearance, pattern, and presentation of keratitis was consistent.

Mr. Abelson then added, "It is indeed an exciting time for Dry Eye, as the industry has made leaps and bounds in understanding this disease. Over the past three years, working in conjunction with our clients, we have produced robust Phase II clinical data on several programs that will be moving into Phase III. This success is a direct result of both the quality of new therapies being developed and the likelihood of success being optimized by the process-driven approach that we have developed here at Ora."

About Ora
Ora, Inc. (www.oraclinical.com) is the world's leading independent ophthalmic product development firm, with 32 FDA approvals during its 30-year history. Ora helps clients garner NDA approvals by providing strategic clinical-regulatory guidance and complete turnkey clinical-regulatory services. Ora's technology-based, concept-to-market services and solutions accelerate development timelines and improve the scientific quality of clinical research along every step of the development pathway.

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Technorati: dry eye clinical research ophthalmic product development FDA approvals