Eyetech Pharmaceuticals Wednesday, August 7, 2002 ,Wednesday, August 07, 2002
New York, NY. August 7, 2002 - Eyetech Pharmaceuticals, Inc., a private biotechnology company focused on the treatment of eye diseases, today announced the early completion of enrollment in two pivotal Phase III trials of Macugen™ (pegaptanib sodium) for the treatment of exudative (wet) age-related macular degeneration (AMD), the leading cause of blindness among Americans over the age of 55. Eyetech enrolled 1,196 patients in the Company’s pivotal clinical trials for treating wet AMD, which constitute the largest clinical trial program for wet AMD enrolled to date. By reaching this milestone, the Company received $54.2 million from its Series C investors, representing the second installment of a total in excess of $108 million raised in July 2001.
The clinical trials are being conducted at 117 investigational sites throughout the world to measure vision stabilization and/or improvement associated with Macugen™ (pegaptanib sodium), an aptamer which binds to and neutralizes Vascular Endothelial Growth Factor (VEGF), as a stand-alone treatment, as well as in combination with photodynamic therapy (PDT) for patients eligible for PDT. Eyetech’s clinical sites are located in the United States, Canada, South America, Europe, Israel and Australia. The United States Food and Drug Administration (FDA) has granted Macugen™ (pegaptanib sodium) “fast-track” designation for the treatment of exudative (wet) AMD and diabetic macular edema (DME) because of the potential of Macugen™ (pegaptanib sodium) to meet an unmet medical need. Eyetech is also conducting Phase II clinical trials with Macugen™ (pegaptanib sodium) for the treatment of DME.
“We are pleased at having reached this critical enrollment milestone, well ahead of our previously announced target date,” said Eyetech’s Co-Founder and Chief Executive Officer, David Guyer, M.D. “We are gratified by the high level of enthusiasm and interest among physicians and patients participating in our clinical trials, which is reflected in the rapid enrollment rate. We look forward to completing clinical development of Macugen™ (pegaptanib sodium) and bringing this important product to market to help fight blindness.”
"The swiftness with which these trials were enrolled demonstrates a substantial commitment to developing ground-breaking treatments for AMD patients who currently have limited options for treating this disease," said Morton F. Goldberg, M.D., Professor and Chairman of the Department of Ophthalmology at the Johns Hopkins University School of Medicine, Director of the Wilmer Opthalmological Institute, and a member of Eyetech’s Scientific Advisory Board.
ABOUT Macugen™ (pegaptanib sodium)
Macugen™ (pegaptanib sodium), formerly known as EYE001, is Eyetech Pharmaceuticals’ lead product candidate. The Company acquired the worldwide rights for this anti-VEGF aptamer from Gilead Sciences in March 2000. Currently being investigated as a treatment for exudative (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME), the two leading causes of blindness in the adult population, Macugen™ (pegaptanib sodium) has shown in early clinical trials the ability to inhibit blood vessel growth and stabilize and/or reverse blood vessel leakage and improve vision by 3 lines or more in 26% of patients.
ABOUT WET AMD
The leading cause of irreversible vision loss among Americans over the age of 55, AMD occurs in two different forms: dry AMD and wet AMD. The wet form accounts for 200,000 new cases of bleeding per year with a prevalence of 1.2 million cases in the U.S. alone.
Wet AMD is characterized by the proliferation of abnormal blood vessels into the area beneath the retina. This process, known as angiogenesis or neovascularization, results in fragile blood vessels that leak fluid and blood into the macula, causing damage to the area and resulting in a rapid loss of central vision, which is critical for tasks such as reading, driving, watching television and recognizing faces.
ABOUT DME
The US Centers for Disease Control and Prevention (CDC) estimate that 11 million Americans have diagnosed diabetes, while an additional 6 million have diabetes that has not been diagnosed. DME, which affects approximately 135,000 Americans each year, is the largest cause of blindness-related lost income in working-age adults and is the leading cause of blindness in adults under the age of 55. Decreased vision is the main symptom and results from fluid and lipid leaking from retinal blood vessels. Laser photocoagulation is the only currently recognized therapy, but is not effective in improving visual acuity in most patients with this disorder.
ABOUT EYETECH
Eyetech Pharmaceuticals, Inc., is a privately-held, New York City-based biopharmaceutical company dedicated to development and commercialization of novel drugs to reduce and prevent vision loss caused by eye diseases. Eyetech is also focused on developing new technologies to deliver drugs safely to the back of the eye. The Company has brought together experienced pharmaceutical industry executives and a world-class team of thought-leaders in ophthalmology from leading medical centers and medical schools, such as Harvard Medical School, Stanford, the University of Chicago, Johns Hopkins and Columbia, to build a pre-eminent ophthalmics company.
Contacts:
Burns McClellan, Inc.
Justin Jackson 212 213 0006
