Only anti-VEGF treatment for wet AMD to replicate outcomes from randomized clinical trials in routine clinical practice
Bayer Pharma AG today announced new data from the interim analysis of the real life evidence (RLE) study RAINBOW. In this study of wet age-related macular degeneration (wet AMD) patients treated in France, EYLEA® (aflibercept solution for injection into the eye) demonstrated consistent outcomes with those seen in its pivotal randomized clinical trials. At 52 weeks, patients achieved a mean gain of 6.2 letters with a mean 6.3 injections. The results were presented at the 16th Congress of the European Retina, Macula and Vitreous Society (EURETINA, 8-11 September, Copenhagen/Denmark). They show that patients were able to maintain the rapid visual and anatomical improvements seen after the initial loading phase.
“These data are promising for patients with wet AMD and for physicians, who will welcome the representative body of data from the real world setting. The findings illustrate the effectiveness of EYLEA® in routine clinical practice and reassure healthcare providers that they are choosing a treatment option with predictable outcomes,” said Prof. Michel Weber, MD, PhD, Head of the Ophthalmic Department, University Hospital of Nantes, France.
“Alongside previously reported findings from real life evidence studies in the UK, Germany, Sweden, and Japan, the RAINBOW results suggest that EYLEA® is the first anti-VEGF treatment for wet AMD shown to consistently demonstrate benefits seen in randomized clinical trials in day-to-day clinical practice,” added Dr. Patrick Bussfeld, Head of Medical Therapeutic Area Ophthalmology at Bayer. “Our ongoing real life evidence program includes studies of more than 20,000 patients from 15 countries and we therefore look forward to seeing more data and insights from both our program as well as independent studies.”
RAINBOW is an ongoing four-year retrospective and prospective observational study assessing the real life outcomes in 593 treatment-naïve wet AMD patients being treated with EYLEA® in 55 centers across France. Patients were to be treated according to the EU Summary of Product Characteristics (EU SmPC) with one injection per month for three consecutive doses, followed by one injection every two months. The patients’ first injections took place between January 2014 and March 2015. The primary endpoint is change in best-corrected visual acuity, BCVA (ETDRS letters) from baseline to 52 weeks. Secondary endpoints are the proportion of patients who gained ≥15 or lost >15 letters, mean change from baseline in central retinal thickness (CRT) at 12 months, and adverse events. In the interim analysis, covering 196 patients, approximately 62.8% were female and the mean age was 78.8 years. At baseline, the mean duration of wet AMD was 21 days with a mean baseline BCVA of 57.7 letters.
In this interim analysis of 196 patients, the subgroup of patients who received three initial injections within less than 120 days (n=179) achieved a mean gain in BCVA at 52 weeks from baseline of 7.4 letters (P<0.001) compared to 6.2 letters (P<0.001) mean gain in BCVA for the full population. Patients in the pooled analysis of EYLEA®’s pivotal phase III trials, VIEW 1 and VIEW 2, gained 8.4 letters at 52 weeks. Additionally, the proportion of patients gaining ≥15 letters was 25.0% in RAINBOW versus 30.6% and 31.4% in the VIEW 1 and 2 studies, respectively, while 4.1% had a loss of >15 letters in the RAINBOW study. Mean reduction in CRT from baseline was -108μm (p<0.001) compared to -128.5μm and -149.2μm in the VIEW 1 and 2 studies, respectively. The mean number of injections was 6.3 in the RAINBOW study versus 7.5 in both the VIEW 1 and VIEW 2 studies.
Adverse event findings are consistent with the known safety profile of EYLEA®. The most common treatment-related adverse events in the RAINBOW study were eye pain (1.5%), vitreous floaters (1.0%) and transient ischaemic attack (0.5%).
About Wet Age-Related Macular Degeneration
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.
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.