Bayer HealthCare has announced that EYLEA (aflibercept solution for injection, known in the scientific literature as VEGF Trap-Eye) has achieved the primary endpoint in two pivotal phase III trials for the treatment of diabetic macular oedema (DMO),1 the leading cause of sight loss in people suffering from diabetes. These results from the phase III trials, VIVID-DME and VISTA-DME, were presented at the13th EURETINA Congress in Hamburg, Germany.
The data show that EYLEA 2 milligrams (mg) when dosed either monthly or once every two months (after 5 initial monthly injections), achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. Both treatment arms demonstrated similar improvements in BCVA.
Dr Sobha Sivaprasad, Consultant Ophthalmologist, Moorfields Eye Hospital and King's College Hospital London commented on the data, "DMO is a condition that needs to be treated effectively to preserve sight, so it is important to have treatment options available that work for patients and the results seen in these trials of Eylea are very promising."
DMO is caused by a complication of diabetes called diabetic retinopathy. Clinically significant DMO occurs when fluid leaks from damaged blood vessels beneath the macula, the part of the retina responsible for central vision. Fluid beneath the macula can cause severe sight loss or blindness.
The VIVID-DME and VISTA-DME trials share a similar design: both were randomised, double-masked, active control trials to evaluate safety and efficacy of EYLEA in patients with DMO. Patients in both trials were randomised to receive EYLEA 2 mg either once every month or once every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation.[1,3,4]
In the VIVID-DME trial, after one year patients receiving EYLEA 2 mg monthly had a mean change from baseline in best-corrected visual acuity (BCVA) of 10.5 letters (p
In the VISTA-DME trial, after one year patients receiving EYLEA 2 mg every month had a mean change from baseline in best-corrected visual acuity (BCVA) of 12.5 letters (p
In these trials, EYLEA was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the treatment groups and the laser control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across the treatment groups and the laser control group. AEs were typical of those seen in other studies in patients with diabetes receiving intravitreal anti-VEGF therapy. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME trials included conjunctival haemorrhage, eye pain, and vitreous floaters. The most frequent non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the laser control group.
Bayer HealthCare plans to submit an application for marketing approval for the treatment of DMO in Europe later in 2013. EYLEA has been licensed in the UK for the treatment of wet age related macular degeneration (wAMD) since December 2012 and was recommended by NICE for this use on the NHS in England and Wales in July 2013. EYLEA has also been accepted by the SMC for use within NHS Scotland for the treatment of wAMD7 and was approved by the European Commission for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) on 29th August 2013.
About diabetic macular oedema (DMO)
DMO is the leading cause of sight loss in people suffering from diabetes. It is caused by a complication of diabetes called diabetic retinopathy. Clinically significant DMO occurs when fluid leaks from damaged blood vessels beneath the macula, the part of the retina responsible for central vision. Fluid beneath the macula can cause severe sight loss or blindness.
About the phase III DMO Programme[3,4,8]
The phase III DMO programme consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST-DME, and one open label single arm safety trial in Japanese patients (VIVID-Japan). All three double masked studies have three treatment arms, where patients are randomised to receive either EYLEA 2 mg monthly, EYLEA 2 mg every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation. The primary endpoint of all three studies is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity. The VIVID-DME, VISTA-DME, VIVID-EAST-DME, and VIVID-Japan studies are ongoing. Both the VISTA-DME and VIVID-DME trials will continue as planned up to 148 weeks.
EYLEA (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. EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors. EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.