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Final Phase 2 Results Presented at Retina Society Meeting
Statistically significant reduction in the size of the affected area of the retina demonstrated
Berlin, Germany, September 28, 2008 - VEGF Trap-Eye can achieve durable
improvements in visual acuity and in biologic measurement parameters in the
formation of new blood vessels in the treatment of age-related macular
degeneration (AMG). This was shown in the final evaluation of a Phase 2 study
presented at the annual meeting of the Retina Society in Scottsdale, Arizona.
These parameters include retinal thickness and active choroidal
neovascularization lesion size (the damaged part of the retina). Bayer
HealthCare and Regeneron Pharmaceuticals, Inc (Nasdaq:REGN) are developing VEGF
Trap-Eye together. The treatment successes continued for up to a year.
The study showed that VEGF Trap-Eye was also associated with a reduction in the
size of the choroidal neovascular membrane (CNV), the active lesion that is the
underlying cause of vision loss in patients with wet AMD. Patients receiving
monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 milligrams (mg) for 12
weeks followed by PRN dosing achieved mean improvements in visual acuity versus
baseline of 9.0 letters (p<0.0001 versus baseline) and 5.4 letters (p<0.085
versus baseline), respectively. Patients in the 2.0 mg monthly cohort also
achieved a statistically significant 1.75 mm2 reduction in total lesion size. A
reduction in total lesion size was not seen in the cohort initially dosed with
0.5 mg monthly.
"Progression of the active CNV lesion and resulting vision impairment are an
inevitable consequence of untreated wet AMD. The reduction in total active CNV
lesion size achieved with VEGF Trap-Eye treatment in this Phase 2 clinical
study could potentially translate into clinically meaningful outcomes in the
larger, controlled Phase 3 studies that are underway," stated Jason Slakter,
M.D., head of the independent reading center for the study and a Clinical
Professor of Ophthalmology, New York University School of Medicine, New York.
In this double-masked Phase 2 trial, participants were initially treated with
either monthly or quarterly fixed dosing for 12 weeks and then continued to
receive treatment for another 40 weeks on a PRN (as needed) dosing schedule.
Patients receiving fixed monthly doses of VEGF Trap-Eye of either 2.0 or 0.5
milligrams (mg) for 12 weeks (i.e. 4 fixed doses) followed by PRN dosing
achieved mean improvements in visual acuity versus baseline of 9.0 letters
(p<0.0001 versus baseline) and 5.4 letters (p<0.085 versus baseline),
respectively, at the end of one year. The proportion of patients with vision of
20/40 or better (part of the legal minimum medical requirement for an
unrestricted driver's license in the U.S.) increased from 23 percent at
baseline to 45 percent at week 52 in patients initially treated with 2.0 mg
monthly and from 16 percent at baseline to 47 percent at week 52 in patients
initially treated with 0.5 mg monthly. During the week 12 to week 52 PRN dosing
period, patients initially dosed on a 2.0 mg monthly schedule received, on
average, only 1.6 additional injections and those initially dosed on a 0.5 mg
monthly schedule received, on average, 2.5 injections.
Patients receiving monthly doses of VEGF Trap-Eye of either 2.0 or 0.5 mg for
12 weeks followed by PRN dosing also achieved mean decreases in retinal
thickness versus baseline of 143 microns (p<0.0001 versus baseline) and 125
microns (p<0.0001 versus baseline) at week 52, respectively.
While PRN dosing following a fixed quarterly dosing regimen (with dosing at
baseline and week 12) also yielded improvements in visual acuity and retinal
thickness versus baseline at week 52, the results generally were not as robust
as those obtained with initial monthly treatment.
"Anti-VEGF therapy has dramatically changed the treatment paradigm for wet AMD,
and improvement in visual acuity is now feasible in most patients. The biggest
challenge we have is that with our current drugs, the majority of patients need
frequent injections into their eye to maintain their visual acuity gains,"
stated David M. Brown, M.D., a study investigator and a retinal specialist at
The Methodist Hospital in Houston."These study results reinforce our interest
in further exploring whether continued administration of VEGF Trap-Eye on an
as-needed basis after an initial period of fixed dosing can maintain a
durability of effect over time in controlled Phase 3 clinical studies."
VEGF Trap-Eye was generally well tolerated and there were no drug-related
serious adverse events. There was one reported case of eye inflammation
(culture-negative endophthalmitis/uveitis) in the study eye, which was deemed
not to be drug-related. The most common adverse events were those typically
associated with intravitreal injections.
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 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 VIEW 1 study
(http://www.regeneron.com/vegftrap_eye.html) is currently enrolling patients in
the United States and Canada and the VIEW 2 study (www.view2study.com) is
currently enrolling patients in Europe, Asia Pacific, Japan and Latin America.
The companies are collaborating on the global development of VEGF Trap-Eye for
the treatment of wet AMD, diabetic eye diseases, and other eye diseases and
disorders. Bayer HealthCare will market VEGF Trap-Eye outside 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 trigger 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 eye, 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 can prevent abnormal blood vessel formation and vascular leak, has proven
beneficial in the treatment of wet AMD.
About Wet AMD
Age-related Macular Degeneration (AMD) is a leading cause of acquired
blindness. Macular degeneration is diagnosed as either dry (nonexudative) or
wet (exudative). In wet AMD, new blood vessels grow beneath the retina and leak
blood and fluid. This leakage causes disruption and dysfunction of the retina
creating blind spots in central vision, and it can account for blindness in wet
AMD patients. Wet AMD is the leading cause of blindness for people over the age
of 65 in the U.S. and Europe.
About Bayer HealthCare
The Bayer Group is a global 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, 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, Consumer Care,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
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.
