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Written Statement of Guy S. Eakin, Ph.D.
Vice President of Scientific Affairs
BrightFocus Foundation

to the

U.S. Food and Drug Administration
Dermatologic and Ophthalmic Drugs Advisory Committee
Open Meeting of June 17, 2011

Thank you for the opportunity to make a statement to the Committee. My name is Guy Eakin, and I am the Vice President of Scientific Affairs for the BrightFocus Foundation(or BrightFocus). We are a leading U.S.-based nonprofit that supports research and public information on three neurodegenerative diseases that primarily affect the elderly. Among these is age-related macular degeneration, a disease that in its broadest definition affects 11 million people in the U.S. This is nearly as high as the number of people who currently live with, or have ever been diagnosed with, cancer.

Directly or indirectly, macular degeneration affects many BrightFocus constituents, including patients, family members, and other caregivers. People living with macular degeneration are quick to affirm the statistic that Americans fear vision loss more than they fear cancer, HIV/AIDS, stroke, heart disease, or the loss of any other of their senses.

As BrightFocus' policies prevent us from endorsing specific products, we have no position on the science behind aflibercept ophthalmic solution and no financial relationship to Regeneron, the drug maker. We are here to represent the thousands of patients and families who have shared their stories with us, and to express these concerns in a few main points.

Above all, patients want control.

Our friend and volunteer, Marion Reh Gurfein, is a talented poet and artist who developed AMD over a decade ago, in her early 80's. Through the wonders of assistive technologies, she remains a diligent, if painstaking, reader of newspapers. A former art teacher, her art has evolved from intricate sketch work to no less astounding sculptures of brightly colored paper, which is a medium her talented hands continue to skillfully manipulate, in spite of the distortion and dimming of her vision. What she says is, “Don't be ashamed to admit your handicap. Work with and around it, and ask for assistance when needed, so you can take control again.” She and many others are asking for your help in asserting that control.

For the people we serve, no matter how independently they may live, achieving control over macular degeneration requires evidence-based advice, supportive networks, and, importantly, multiple therapeutic options. As the members of the FDA panel are aware, wet AMD has few treatments. We also know that these don't work for all patients. One popular product advertises “maintenance of vision” in the largest portion of patients treated. The fine print reminds us that “maintenance” is paradoxically defined as an acceptable level of loss of vision. One thing remains clear in our stakeholders' view: there is no acceptable level of vision loss.

While current drugs have truly made a difference for millions, we need more options. We need treatments that require less frequent doctor visits, which help both the patient and the caregiver. We need treatment regimens for which patients find adherence and compliance to be a simple matter. And we need entirely new approaches to prevention and treatment for the disease, whichis the leading cause of permanent vision loss for those over age 65. As the baby boomers age, the problem grows, and sadly, the commitment to research has shrunk.

As the FDA considers the many comments on this subject, BrightFocus offers our appeal with the voices of 11 million people affected by AMD. Nearly 2 million people suffer from the most advanced forms of AMD, and we predict that 200,000 of them will experience worsening conditions, even under existing treatments. For these Americans who struggle every day to retain their independence, please consider the benefit of facilitating new options for improving their vision and their lives.

Thank you.

# # #

Guy S. Eakin, Ph.D.
Vice President of Scientific Affairs
BrightFocus Foundation
22512 Gateway Center Drive
Clarksburg, Maryland 20871
Telephone: (301) 556- 9359
Fax: (301) 948 4403
Email: vpsa@brightfocus.org

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