Eylea (aflibercept) Granted Marketing Authorisation for the Treatment of wet AMD
Bayer HealthCare wishes to announce that Eylea (aflibercept “VEGF trap-eye”) intravitreal injection received marketing authorisation in Europe for the treatment of neovascular (wet) age-related macular degeneration (AMD).
VEGF is an endogenous protein whose role is to trigger angiogenesis supporting the growth of tissues and organs. However, in certain diseases, such as wet AMD, elevated levels of VEGF are associated with the growth of abnormal new blood vessels in the eye, which exhibit increased permeability that leads to oedema and loss of vision. It is believed that anti-VEGF treatment helps decrease vascular permeability and oedema.
Previously licenced anti-VEGF therapy in wet AMD has been shown to halt the progression of the disease and even make visual restoration possible, but with the main limitation of frequent need for re-injections and monthly monitoring in order to maintain optimal vision.
Aflibercept is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 fused to a portion of human IgG1. The binding affinity of intravitreal aflibercept to VEGF is substantially greater than that of other anti-VEGF including bevacizumab or ranibizumab, which could translate into a longer duration of action in the eye, allowing for less frequent dosing.
The approval of Eylea for the treatment of neovascular AMD is based on data from the VIEW (VEGF Trap Eye Investigation of Efficacy & Safety in Wet AMD) studies, two similarly designed Phase 3 trials comparing monthly and every-2-month dosing of intravitreal aflibercept injection with monthly ranibizumab.1
Study design
The safety and efficacy of Eylea were assessed in two randomised, multi-centre, double-masked, active-controlled studies in patients with wet AMD (VIEW1 and VIEW2) including a total of 2,412 patients (aged 49 to 99 years; mean 76 years). In each study, patients were randomised to 1 of 4 dosing regimens:
1) Aflibercept administered at 2mg every 8 weeks following 3 initial monthly doses (Eylea 2Q8);
2) Aflibercept administered at 2mg every 4 weeks (aflibercept 2Q4);
3) Aflibercept administered at 0.5mg every 4 weeks (aflibercept 0.5Q4); and
4) Ranibizumab administered at 0.5mg every 4 weeks (ranibizumab 0.5Q4).
In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing fewer than 15 letters of visual acuity at week 52 compared to baseline.
All Eylea groups clinically equivalent to monthly ranibizumab
All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point. At week 52, 95.1% (VIEW1) and 95.6% (VIEW2) of patients in the Eylea 2Q8 treatment group maintained vision compared to 94.4% of patients in the ranibizumab 0.5Q4 group (both studies).
Figure 1: Mean change of visual acuity from baseline to week 52 from the combined data from VIEW1 and VIEW2
All aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups.
Conclusion
Intravitreal Eylea dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. The recent approval of this VEGF trap-eye offers an effective new treatment option for patients with wet AMD, with the every-2-month regimen having the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring.
1- Heier JS, et al. Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration. Ophthalmology. 2012 Dec;119(12):2537-48.
Full prescribing information and references available from Bayer Ltd. Telephone: (01) 299 9313. MIMS Ireland Copyright®