Best And Brightest Gather To Solve The Dry Eye Development Enigma

Main Category: Eye Health / Blindness
Article Date: 27 May 2010 - 10:00 PDT


The Dry Eye Summit, which attracted hundreds of industry leaders to the Harbor Beach Marriott in Ft. Lauderdale the day before the opening of ARVO, spurred discussion on innovation and collaboration among ophthalmic clinical researchers, scientists, regulators, pharmaceutical executives, FDA officials and venture capitalists. Top experts in the field packed into the venue to address the complexities of the drug development process for dry eye.

"There are an estimated 100 million people who suffer from Dry Eye. It is a complex disease with multiple underlying etiologies and currently there is only one approved prescription drug, leaving a significant unmet need among patients. By bringing together the best and brightest minds across a myriad of key business and scientific disciplines, with a passion for innovation, we hope to move the industry forward," said Stuart Abelson, President & CEO of Ora, Inc., a lead sponsor of the Summit.

The full-day Summit included presentations from medical professionals, statisticians, clinical leaders and others. In addition to the dozens of speakers Wiley Chambers, MD, Acting Director for the FDA Center for Drug Evaluation and Research presented and participated in several panels at the Summit. "We appreciate the FDA contributing the time and participation of a key resource. Dr. Chamber's insight and accessibility were important to provide guidance on regulatory matters," Abelson added.

After a review of the history of dry eye by Dr. Michael Lemp, Dr. Oliver Schein delivered an epidemiological perspective of the disease and presented the fact that dry eye is estimated to affect 20% of the general population in some form. Dr. Stephen Pflugfelder went on to discuss the role of inflammation in the study of dry eye, and Dr. Reza Dana highlighted the challenges of using animal models to predict drug efficacy. A second group of researchers -- comprised of Dr. Gail Torkildsen, Dr. Darlene Dartt, and Keith Lane -- took a deep dive into the biological mechanics of how malfunctions of the complex tear production and blink systems can lead to Dry Eye.

Regulatory and clinical leaders described the importance of careful clinical trial design in drug development and the hurdles to appropriate formulation in eye drops, including safety, sterility and manufacturing concerns. Lester Kaplan, PhD Former Executive VP R&D, Allergan and Executive Chairman for Aciex Therapeutics moderated a panel discussion/conversation on establishing clinically relevant endpoints and general criteria for inclusion/exclusion for Dry Eye subgroups.

During the clinical sessions, George Ousler, Director of Dry Eye for Ora, Inc. discussed a range of technology-based research solutions, including the Controlled Adverse Environment (CAE™), to address the challenges of studying Dry Eye amidst a myriad of environmental confounds. Dr. Jerry D. Cagle, Former Senior VP of R&D and Chief Scientific Officer, Alcon, moderated a discussion with Dr. Wiley Chambers, Dr. Mark Abelson, George Ousler, and Dr. Stephen Pflugfelder on lessons learned across dozens of Dry Eye development programs and regulatory application processes.

Katie Kennedy, MSE, Director of Biostatistics for Statistics and Data Corporation who has been the statistician on many of the clinical dry eye programs conducted in the last five years walked the group through the important considerations when choosing analysis method and other critical factors that drive statistical power.

Several venture capitalists offered insight into the financing of dry eye drug developments -- where some believe the metrics of dry eye represent an attractive area to invest in new therapies to address unmet patient need. Dayton Misfeldt, Investment Partner, Bay City Capital moderated a panel on financing Dry Eye drug development, critical value inflection points in the development process, and market overview.

Concluding an exciting day of thought provoking sessions, executives from Allergan, Alcon, Bausch + Lomb and Pfizer discussed product attributes and the program stage they consider when making investments to bring promising new developments into the pipeline. Charles McDermott, VP, Business Development, Eye Care and Drug Delivery, Allergan moderated the panel on the criteria companies use when evaluating a potential license.

In addition to those already mentioned, speakers represented Harvard Medical School, iNovia Capital, Inc., Clarus Ventures, Mass Eye & Ear Infirmary, Schepens Eye Research Institute, VIMAC Ventures LLC, Baylor College of Medicine, John Hopkins University Bloomberg School of Public Health, SDC, and Aisling Capital. Attendees to the Dry Eye Summit represented Acucela, Aton Pharma, EyeGate Pharma, GlaxoSmithKline, Inspire Pharmaceuticals, IOBA-University of Valladolid, ISTA Pharmaceuticals, Johnson & Johnson Consumer & Personal Products, Lux Biosciences, Merck, Otsuka and Pfizer.

"The Summit was organized to bring together constituents to drive ophthalmic innovation," added Abelson. "From the feedback we received, this was a very successful event for the industry and we are committed to organizing future gatherings to facilitate advancements in other therapeutic subspecialties of ophthalmology."

About The Dry Eye Summit

The 2010 Dry Eye Summit was a unique one-day learning event that brought together the world's thought leaders in dry eye drug development. Speakers provided practical, usable advice on how to add the proper scientific rigor and best-practice processes to accelerate dry eye drug development. The event took place at the Harbor Beach Marriott in Ft. Lauderdale, FL on Friday, April 30, 2010 and preceded the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Ft. Lauderdale. The event was co-sponsored by Ora, Inc. For more information, visit http://www.dryeyesummit.org.

Source
Ora, Inc.

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