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BrightFocus Spotlights Need for
Macular Degeneration Treatment Options

Background Information

On June 17, the U.S. Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee held an open public hearing on the license application of a proposed product for treatment of wet age-related macular degeneration (AMD).

The Advisory Committee will make recommendations to the FDA on the product, aflibercept ophthalmic solution (proposed trade name EYLEA), sponsored by Regeneron Pharmaceutical, Inc. Committee recommendations are not binding on the FDA, but carry great weight. Should the Advisory Committee give the nod, the FDA could approve the product as early as August of this year.

Open hearings are an important part of the committee review process, giving interested persons a chance to present information or views.

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Delivered Comments

Prior to the hearing, the Advisory Committee sought written comments and/or requests to speak from people affected by the disease. Patients, family members, advocacy groups, and others were invited to voice their opinions regarding their experiences with AMD or to comment on the drug itself.

As part of our commitment to the many people with vision loss, including the 11 million Americans with AMD, the BrightFocus Foundation's Macular Degeneration Research program submitted comments for the written record, and requested and was granted time to speak at the hearing. BrightFocus, which has no financial interest in the product and makes no product endorsements, focused instead on the concerns of the many AMD patients and families who share their stories with us. 

More information about the proceedings is available online at www.fda.gov/AdvisoryCommittees/Calendar/ucm256594.htmor by calling the FDA Advisory Committee Information Line at 1-800-741-8138 (Code: 3014512534). Transcripts, slides, and other meeting materials will be available on the FDA website approximately 3 weeks after the June 17 meeting.

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Oral Remarks 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

Guy Eakin, Ph.D., Vice President of Scientific Affairs, BrightFocus FoundationThank you to the organizers and panel for the opportunity to speak on behalf of the constituents of the BrightFocus Foundation(or BrightFocus).

My name is Guy Eakin, and I am the Vice President of Scientific Affairs at BrightFocus.

BrightFocus is a U.S.-based and donor-supported nonprofit organization that provides public information and academic research funding addressing three neurodegenerative disorders, including age-related macular degeneration and glaucoma.

I am here today to voice the patient's desire for access to greater choice in therapeutic options.

To be absolutely clear, we are not here to endorse any particular product. Our policies prevent such endorsements. We have no financial relationship to any manufacturers of existing or proposed AMD treatments, including Regeneron.

I am here to provide a voice for the many thousands of individuals who have shared their stories with BrightFocus. Most of these are people who have AMD; others include their family members and extended-care networks. These Americans know very well what macular degeneration is, and they fully understand its devastating effects.

I should note that I am one of those people who can testify to how heartbreaking this disease can be. My own grandmother, now deceased, was an academic historian, prolific researcher, and author for her entire life. Reading was her life's work.

As her AMD progressed, the stories of the historical figures who she knew as closely as her own family became increasingly, frustratingly, and-in a clinical sense of the word-depressingly inaccessible to her despite adherence to the standard of care for AMD treatments.

AMD is not a topic on the tip of the nation's tongue. Relatively few people know what this disease is. Yet recent reports in the literature suggest that 11 million people in the US may have some form of AMD. That's comparable to the number of people in the U.S. who have been given a cancer diagnosis.

In our conversations with these people, a few things become very apparent.

For individuals who are slowly and irreversibly losing their vision, there is a palpable hunger for new therapeutic options. There is a thirst for understanding state-of-the-art science, and an inspiring drive to overcome the limitations imposed by this disease.

As a foundation actively engaged in supporting academic research into new preventive and therapeutic strategies, we know that the future may bring treatments based on new disease-modifying mechanisms and even options for repairing damaged tissue, to say nothing of the great need for therapies addressing the dry form of the disease.

Unfortunately, that future is still too far away for today's patients. Many of our constituents express a need for more than the two most commonly-prescribed treatments for wet AMD.

Many, like my grandmother, have watched their vision slowly decline despite careful adherence to their treatment regimens. This is a very vulnerable population. Surveys indicate that more Americans fear vision loss than fear cancer, stroke, or heart disease. There is an incredible temptation to grasp at any supposed remedy, regardless of the level of scientific backing. Clearly, this makes the panel's work that much more complex, and important.

One of our friends, Marion Reh Gurfein, is a talented artist, poet, and teacher. She is also one of the 11 million with AMD, in her case an advanced form. Unfortunately, she could not attend today, but graciously allowed me to quote her simple advice to AMD patients: “Ask for assistance when needed, so you can take control again.”

To the panel, as you consider today's objectives, and any future therapies, I would like to point out that you ARE being asked for assistance, so that millions can regain greater control of their lives again.

I sincerely thank you for your time and the opportunity to speak with you today.

# # #

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
www.brightfocus.org

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Share Your Stories

We welcome your input, a key component of BrightFocus advocacy. If you would like to share any stories about living with age-related macular degeneration or have questions for us at BrightFocus, you may:

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Original Post Date: 06/18/11

Last Review: 08/30/13


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