MISSISSAUGA, ON FEBRUARY 27, 2020 – Bayer is pleased to announce that results from the Phase IV ALTAIR study, which evaluated the efficacy and safety of EYLEA^® (aflibercept solution for intravitreal injection) using two different treat and extend (T&E) dosing regimens in patients with wet AMD (age-related macular degeneration), were recently published in Advances in Therapy. In the study, at week 96, up to 60% of patients were able to achieve an injection interval of 12 weeks or more, with more than 40% able to achieve an injection interval of 16 weeks.[1] This information has not been approved by Health Canada.

Dr. Patrick Bussfeld, VP and Head Medical Affairs, Ophthalmology at Bayer, said “A significant unmet need in managing wet AMD has been tailoring the treatment regimen to suit the needs of the individual patient. However, under a proactive treat and extend regimen, there is potential to reduce the number of injections for certain patients. With as little as three injections required for a substantial number of patients in the second year, this means a considerable burden reduction for patients and could also free up healthcare time and resources.”

In the Phase IV ALTAIR, 246 patients received aflibercept treatment for three consecutive monthly doses followed by a dose eight weeks later. At week 16, patients were randomized 1:1 into two groups, in which the T&E dosing regimen was applied with either a two-week interval adjustment or a four-week interval adjustment.[1]

Results showed that both the two-week and four-week interval adjustments with aflibercept delivered good vision gains. At the primary endpoint at week 52, change from baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score was 9.0 and 8.4, respectively. These results were maintained out to week 96, with a mean improvement of 7.6 letters achieved by patients in the two-week adjustment group and 6.1 letters for those in the four-week adjustment group.[1]

Adverse event findings during the study were consistent with the known safety profile for aflibercept.[1]

Wet AMD is a disease of the central retina that can progress rapidly without appropriate and ongoing treatment.[2]  , [3] Utilizing a T&E dosing regimen with intravitreal anti-VEGF therapy, after a set number of initial monthly doses, clinicians can adjust the treatment interval to the individual needs of every patient, by gradually extending or shortening the injection interval, based on the individual patient’s disease activity. 

About ALTAIR

The Phase IV ALTAIR study evaluated the efficacy and safety of aflibercept using two different T&E dosing regimens in Japanese patients with wet AMD. Patients taking part in the study received aflibercept treatment for three consecutive monthly doses followed by an injection at week 16 of the study. At week 16, patients were randomized 1:1 into two groups, in which the T&E dosing regimen was applied with either a four-week interval adjustment (4W-Adj) or a two-week interval adjustment (2W-Adj). A total of 246 patients at 40 Japanese study sites with an average age of 74 years participated in the trial.[1]

Following a T&E dosing approach, injection interval was defined by treating physicians based on the pre-defined criteria that considered imaging findings and changes in best-corrected visual acuity (BCVA). The interval between intravitreal aflibercept injections after the 16-week randomization could not be shorter than eight weeks or longer than 16 weeks.[1]

The primary endpoint in ALTAIR was change from baseline in BCVA, as measured by ETDRS letter score, at week 52. Other efficacy endpoints included the proportion of patients who maintained vision, proportion of patients who gained at least 15 letters of vision compared to baseline, mean change in Central Retinal Thickness (CRT) from baseline, and proportion of patients without fluid on Optical Coherence Tomography (OCT), at Weeks 52 and 96. Treatment exposure-related parameters such as number of injections and last injection interval were also investigated.[1]

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 intravitreal 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.

Aflibercept has been approved under the brand name EYLEA^® in approximately 100 countries. In Canada, EYLEA^® is approved for five indications including the treatment of neovascular (wet) age-related macular degeneration (AMD), the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO), the treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO), the treatment of diabetic macular edema (DME), and the treatment of myopic choroidal neovascularization (myopic CNV). Around 30 million vials of EYLEA^® have been sold since its launch worldwide, resulting in over four million patient-years of experience.

Bayer and Regeneron Pharmaceuticals, Inc. have been collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to EYLEA in the U.S. Bayer has licensed the exclusive marketing rights outside the U.S., including Canada, where the companies share equally the profits from sales of EYLEA^®, except for Japan where Regeneron receives a percentage of net sales.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.ca.

Contact:

Bayer Inc.

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mediacanada@bayer.com

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

• [1] a b c d e f g Ohji, M., Takahashi, K., Okada, A.A. et al. Adv Ther (2020). https://doi.org/10.1007/s12325-020-01236-x
• [2]Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012;75:26-39.
• [3]Lim LS, Mitchell P, Seddon JM, et al. Age-related macular degeneration. Lancet. 2012;379:1728-38.