February 12, 2018
New data for aflibercept show prolonged injection intervals
Data from ALTAIR study demonstrate injection appointments at an interval of 12 weeks or more / New data submitted to EMA to update the current product informationBerlin, February 12, 2018 - Bayer submitted new data to the European Medicines
Agency (EMA) to update the current Eylea® (aflibercept injection into the eye)
product information. The new data recommends extending the dosing interval
during the first year of treatment. If approved, this alternative treatment
option would give clinicians the opportunity to extend injection intervals with
Eylea to 12 weeks and beyond, based on a patient's individual needs during the
first year of treatment. Currently the Eylea product information recommends a
dosing regimen once every two months in year one, following three initial
consecutive monthly doses in patients with wet AMD (Age-related macular
degeneration). The proposed label change is based on data from the recently
presented ALTAIR trial, where at the end of the first year approximately 60% of
patients on Eylea had their next scheduled appointment at an interval of 12
weeks or more.
"Based on the original pivotal studies with anti-VEGF therapy, patients with
wet AMD would have required 12 visits to the clinic for either injections or
monitoring in the first year of treatment," said Dr. Michael Devoy, Head of
Medical Affairs & Pharmacovigilance of Bayer AG's Pharmaceuticals Division and
Bayer Chief Medical Officer. "Having the additional opportunity to extend the
injection intervals of Eylea to 12 weeks and beyond in the first year of
treatment in a responsible and controlled manner could potentially result in as
little as three to four visits to the clinic in the second year for some
patients, whilst maintaining excellent visual outcomes and the ability to see."
The recently presented data from the ALTAIR T&E (Treat-and-Extend) Phase IV
study adds further weight to the growing body of real world evidence data
supporting the benefits of an early proactive regimen with Eylea.
Eylea has been approved in the majority of countries for five indications to
treat patients with wet age-related macular degeneration (wet AMD), visual
impairment due to: retinal vein occlusion (RVO; branch RVO or central RVO), and
diabetic macular edema (DME). Eylea has also been approved for the treatment of
myopic choroidal neovascularization. Eylea is the global market leader of
anti-VEGF treatment, with over 16 million doses administered worldwide.
Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global
development of Eylea. Regeneron maintains exclusive rights to Eylea in the
United States. Bayer has licensed the exclusive marketing rights outside the
United States, where the companies share equally the profits from sales of
Eylea, except for Japan where Regeneron receives a percentage of net sales.
About the ALTAIR study
The Phase IV ALTAIR study evaluated the efficacy and safety of Eylea in
Japanese patients with wet AMD, using two different T&E dosing regimens.
Patients taking part in the study received Eylea treatment for three
consecutive monthly doses followed by a single injection after two months at
baseline. At week 16, patients were randomized 1:1 into two groups receiving
treatment at four and two week interval extensions. A total of 255 patients
aged ?50 years at 40 Japanese study sites participated in the trial.
The treatment interval was defined by treating physicians based on the
pre-defined criteria that considered imaging findings and changes in BCVA. The
interval between intravitreal aflibercept injections after the 16 week
randomization visit could not be shorter than 8 weeks or longer than 16 weeks.
The primary endpoint in ALTAIR was change from baseline in best-corrected
visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study
(ETDRS) letter score at week 52. Other efficacy endpoints include the
proportion of patients who maintain vision, proportion of patients who gain at
least 15 letters of vision compared to baseline, mean change in Central Retinal
Thickness (CRT) from baseline, and proportion of subjects without fluid on
Optical coherence tomography, at Week 52 respectively. Treatment
exposure-related parameters like number of injections, last treatment interval
were also investigated.
Adverse event findings are consistent with the known safety profile for
aflibercept and no major differences were observed between treatment arms
during the first 52 weeks. The study will continue until week 96.
At the one year time point of ALTAIR, approximately 60% of patients had their
next scheduled injection appointment at an interval of 12 weeks or more. If
maintained into year two this would mean that some patients would only need to
receive three to four injections per year, which would mark a significant
improvement on the current injection burden of anti-VEGF treatment.
About wet AMD
Age-related macular degeneration (AMD) is a leading cause of acquired
blindness, if left untreated. Macular degeneration is diagnosed as either dry
(non-exudative) 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 VEGF and Eylea® (aflibercept solution for injection into the eye)
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in
the body. Its normal role in a healthy organism is to trigger formation of new
blood vessels (angiogenesis) supporting the growth of the body's tissues and
organs. It is also associated with the growth of abnormal new blood vessels in
the eye, which exhibit abnormal increased permeability that leads to edema.
Aflibercept solution for injection is a recombinant fusion protein, consisting
of portions of human VEGF receptors 1 and 2 extracellular domains fused to the
Fc portion of human IgG1 and formulated as an iso-osmotic solution for
intravitreal administration. Aflibercept acts as a soluble decoy receptor that
binds VEGF-A and Placental Growth Factor (PGF) and thereby can inhibit the
binding and activation of their cognate VEGF receptors.
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