VEGF Trap-Eye: 52-week results from Phase 3 studies with VEGF Trap-Eye for wet age-related macular degeneration (AMD)

Overview VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration

Quelle: BAYNEWS
www.press.bayer.com/baynews/baynews.nsf/id/52-week-results-Phase-III-studies-VEGF-Trap-Eye-AMD-expected-before

Friday - November 5, 2010

Wet age-related macular degeneration:

52-week results from Phase III studies with VEGF Trap-Eye for wet AMD expected before the end of the year

Current status of clinical development program presented at press event

Vienna, November 5, 2010 - The clinical Phase III development program for VEGF Trap-Eye conducted by Bayer Schering Pharma and Regeneron Pharmaceuticals in wet age-related macular degeneration (wet AMD) is progressing extremely well. The 52-week results from the two major VIEW 1 and VIEW 2 studies are expected before the end of the year. The aim of the study is to test a new compound in both the established and in a novel regimen for wet AMD, the leading cause of severe vision loss. This is the largest combined clinical trial program to date in wet AMD.

Professor Ursula M. Schmidt-Erfurth from the University Hospital for Eye Medicine and Optometry in Vienna, Austria, one of 187 VIEW 2 study centers, presented the current status of the clinical trials for VEGF Trap-Eye at a press event on November 5, 2010. "The Phase III VIEW 1 and VIEW 2 trials are currently ongoing to confirm the clinical findings from the Phase II studies to evaluate the safety and efficacy of VEGF Trap-Eye compared with the current standard of care (ranibizumab). We are exploring the potential of a new therapy for wet AMD with a different regimen which has the promise to substantially reduce the treatment burden. The conventional therapy is based on monthly treatments and monitoring which can continue for the lifetime of a patient. This approach is acknowledged as the most effective, but is often altered to less frequent dosing intervals to reduce the associated treatment burden," said Professor Schmidt-Erfurth.

Wet AMD

Wet AMD is the most common cause of legal blindness in elderly people worldwide. 25 to 30 million people worldwide are affected by AMD, and each year about 500,000 new patients are diagnosed. The prevalence of the disease is likely to increase dramatically in the future as more and more people reach old age. The condition is characterized by the formation of abnormal blood vessels beneath the retina that have defective walls and leak fluid (edema), and can also bleed. The progressive exudative process destroys the photoreceptors in the retina, resulting in a rapid loss of sharp, central vision originating from the macula or 'yellow spot' leading to permanent disability.

Implications for the patient

Patients with wet AMD have blurred or distorted vision in the area of highest focus of the eye - where it matters most. All activities for which focused sight is critical become more difficult or even impossible: looking at the person you are talking to, reading, watching TV, using a computer, driving a car, doing housework or pursuing hobbies. In the later stages of the disease, patients may have lost the central visual field entirely.

Technically, patients with wet AMD are not completely blind. A patient can, for example, see the contours of a clock hanging on the wall from the corner of his or her eye - but they cannot necessarily tell the time because the clock will seemingly 'vanish' as soon as the patient tries to focus on the face of the clock. Even though patients do not live in absolute darkness, this type of vision impairment significantly reduces the daily performance and severely limits their mobility and self-reliance. Patients with wet AMD are therefore often classified as legally blind.

VEGF Trap-Eye for wet AMD

The formation of new, abnormal blood vessels in wet AMD appears to be mediated by a biologic trigger, vascular endothelial growth factor (VEGF). Injection of an 'anti-VEGF' compound directly into the eye (intravitreal injection) at regular intervals can stop the formation of abnormal vessels and has been shown help to prevent fluid leakage.

Recent development of new anti-VEGF therapies has substantially changed the treatment and prognosis of wet AMD. More than 90 percent of patients respond to newer anti-VEGF therapies and on average demonstrate improved vision. However, due to the short durability of regular therapy, treatments have to be repeated continuously at short-monthly-intervals which creates a substantial burden for patients, family members and doctors. Studies have shown that as soon as treatment is discontinued, patients lose the obtained benefit. Typical clinical practice is to provide patients with treatment as needed, which may not result in the most optimal benefit.

Bayer Schering Pharma, together with its partner Regeneron Pharmaceuticals, is currently developing VEGF Trap-Eye as an alternative treatment for wet AMD. Due to the high binding affinity to different members of the VEGF family, VEGF Trap-Eye may be effective in longer treatment intervals, which would result in reduced treatment burden for both patients and clinicians.

About the VIEW Program

The VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) program consists of two randomized, double-masked, Phase III clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD). The VIEW 1 study is being conducted in the United States and Canada by Regeneron and the VIEW 2 study is being conducted in Europe, Asia-Pacific, Japan, and Latin America by Bayer HealthCare. The study designs are identical. The VIEW studies are ongoing with initial 52-week primary endpoint data expected before the end of 2010.

In each of the studies, VEGF Trap-Eye is being evaluated for its effect on maintaining and improving vision when dosed as an intravitreal injection on a schedule of 0.5 milligram (mg) every four weeks, 2.0 mg every four weeks, or 2.0 mg every eight weeks (following three monthly doses), as compared with intravitreal ranibizumab (Lucentis®), a registered trademark of Genentech, Inc.) administered 0.5 mg every four weeks during the first year of the studies. As-needed (PRN) dosing with a dose administered at least every 12 weeks but not more often than every four weeks with both agents is being evaluated during the second year of each study. These studies are part of the global development program for VEGF Trap-Eye being conducted by Regeneron and Bayer HealthCare AG and represent the largest clinical trial program to date in wet AMD.

The primary endpoint of these non-inferiority studies is the proportion of patients treated with VEGF Trap-Eye who maintain vision at the end of one year, compared to ranibizumab patients. Visual acuity is defined as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, a standard chart used in research to measure visual acuity. Maintenance of vision is defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS chart. Key secondary endpoints include the mean change from baseline in visual acuity as measured by ETDRS and the proportion of patients who gained at least 15 letters of vision at week 52.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to discover, manufacture and market products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

About Bayer Schering Pharma

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical 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 contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

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Zur Übersicht EYLEA (VEGF Trap-Eye) bei feuchter Makuladegeneration