�Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) proclaimed that patients with wet age-related macular degeneration (AMD) receiving VEGF Trap-Eye in a Phase 2 reference study on a PRN (as needful) dosing schedule continued to show highly significant improvements at 52 weeks in the primary and key secondary endpoints of retinal thickness (an anatomic measuring stick of treatment effect) and vision reach. The 12-week primary terminus results from the fixed-dosing period of the study were presented at the 2007 Retina Society conference in September 2007. The 32-week results of the Phase 2 study were presented at the 2008 Association for Research in Vision and Ophthalmology (ARVO) meeting in Fort Lauderdale, Florida. A full analysis of the 52-week results of the Phase 2 study will be presented at the 2008 meeting of the Retina Society on September 26-28, 2008 in Scottsdale, Arizona.
In this double-masked, prospective, randomized, multi-center Phase 2 trial, 157 patients were randomized to five dosage groups and treated with VEGF Trap-Eye in one eye. Two groups initially received monthly doses of 0.5 or 2.0 milligrams (mg) of VEGF Trap-Eye (at weeks 0, 4, 8, and 12) and three groups received quarterly doses of 0.5, 2.0, or 4.0 mg of VEGF Trap-Eye (at baseline and week 12). Following the initial 12-week fixed-dosing phase angle of the trial, patients continued to receive therapy at the same zen on a PRN dosing schedule based upon the physician judgement of the need for re-treatment in accordance with pre-specified criteria. Patients were monitored for safety, retinal thickness, and visual sharp-sightedness. These data represent the final annual analysis from the 52-week study.
Patients receiving four monthly doses of VEGF Trap-Eye, either 2.0 or 0.5 mg, for 12 weeks followed by PRN dosing thereafter, achieved mean improvements in visual acuity versus baseline of 9.0 letters (p
For all dosage cohorts combined, there was a 5.3 mean letter gather in visual acuity versus baseline at the calendar week 52 evaluation visit (p
VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. There was i reported case of culture-negative endophthalmitis/uveitis in the work eye and one arterial thrombotic consequence, neither of which was deemed to be drug-related. The well-nigh common adverse events were those typically associated with intravitreal injections.
"The 52-week results underline that VEGF Trap-Eye has the potential to significantly
reduce retinal heaviness and meliorate vision," aforementioned Dr. Kemal Malik, fellow member of the Bayer HealthCare Executive Committee responsible for product development. "The further development of this compound is important for millions of people worldwide wHO suffer from this devastating ocular disease."
"Based upon retinene physicians' feedback, there remains a significant unmet medical need for a intervention for wet AMD that can faithfully improve ocular acuity over time without the need for monthly intravitreal injections," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "We are excited about these study findings and the potential for VEGF Trap-Eye to fulfil this demand pending the results of our on-going Phase 3 clinical studies."
About the Phase 3 Program in Wet AMD
Regeneron and Bayer HealthCare initiated a Phase 3 global development program for VEGF Trap-Eye in wet AMD in August 2007. In two Phase 3 trials VIEW 1 and VIEW 2 (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet age related macular degeneration), the companies are evaluating VEGF Trap-Eye dosed 0.5 mg every 4 weeks, 2 mg every 4 weeks, or 2 mg every 8 weeks (following three monthly doses) in direct comparison with ranibizumab (Lucentis�, a registered trademark of Genentech, Inc.) administered 0.5 mg every four-spot weeks according to its U.S. label during the first year of the studies. PRN dosing will be evaluated during the second year of each study. The VIEW1 cogitation (http://www.regeneron.com/vegftrap_eye.html) is currently enrolling patients in the United States and Canada and the VIEW2 study (hypertext transfer protocol://www.view2study.com) is currently enrolling patients in Europe, Asia Pacific, Japan, and Latin America. The companies ar collaborating on the worldwide development of VEGF Trap-Eye for the treatment of wet AMD, diabetic centre diseases, and other eye diseases and disorders. Bayer HealthCare volition market VEGF Trap-Eye external the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
About VEGF Trap-Eye
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to initiation formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the oculus, which lead to the development of wet AMD. The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. Blockade of VEGF, which tin can prevent abnormal blood vessel formation and vascular leak, has proved beneficial in the treatment of stiff AMD.
About Wet AMD
Age-related Macular Degeneration (AMD) is a prima cause of acquired blindness. Macular degeneration is diagnosed as either dry (nonexudative) or wet (exudative). In wet AMD, new roue vessels develop beneath the retina and leak blood and fluid. This escape causes disruption and disfunction of the retina creating blind muscae volitantes in central vision, and it can account for blindness in wet AMD patients. Wet AMD is the ahead cause of blindness for people over the eld of 65 in the U.S. and Europe.
About Bayer
The Bayer Group is a globular enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovational companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the diagnose Bayer Schering Pharma AG. Bayer HealthCare's aim is to find and manufacture products that will improve human and animal health worldwide. Find more entropy at http://www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide in the lead specialty pharmaceutic company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a donation to medical progress and strives to improve the quality of life. Find more selective information at http://www.bayerscheringpharma.de.
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