Bayer receives approval of EYLEA® for second indication in Europe

Date: Sep-05-2013Bayer HealthCare has announced that EYLEA (aflibercept solution for injection, known in the scientific literature as VEGF Trap-Eye) has been approved by the European Commission for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO). This approval marks the second indication for EYLEA in Europe, with the wet age-related macular degeneration (wAMD) indication receiving approval in December 2012.[1]

According to the National Institute for Health and Care Excellence (NICE), in England and Wales, it has been estimated that for every 100,000 population, approximately 17 people aged 40 years or over will require treatment for macular oedema following CRVO annually. CRVO typically increases with age, with over 90 per cent of people with CRVO aged above 50 years. It occurs slightly more frequently in males than females and shows no racial preference. The impact of vision loss associated with CRVO can have a profound effect on vision-related quality of life. Patients may struggle with daily tasks, lose confidence and become increasingly dependent. [2]

Retinal Vein Occlusion (RVO) results from a blockage of the retinal veins that carry blood away from the vascularised surface of the retina. It is the second most common retinal vascular disorder after diabetic retinopathy and is considered to be an important cause of visual loss.[3],[4] RVO can occur in two main different clinical forms depending on the location of the venous blockage: branch RVO (BRVO) or central RVO (CRVO). BRVO is more common than CRVO.[5]

EYLEA has been licensed in the UK for the treatment of wet age related macular degeneration (wAMD) since December 2012[1] and was recommended by NICE for this use on the NHS in England and Wales in July 2013.[6] EYLEA has also been accepted by the SMC for use within NHS Scotland for the treatment of wAMD.[7] Bayer HealthCare plans to submit an application for marketing approval of EYLEA for the treatment of DMO in Europe in 2013.
About Central Retinal Vein Occlusion (CRVO)

Retinal Vein Occlusion (RVO) results from a blockage of the retinal veins that carry blood away from the vascularised surface of the retina. It is the second most common retinal vascular disorder after diabetic retinopathy and is considered to be an important cause of visual loss.[3],[4] RVO can occur in two main different clinical forms depending on the location of the venous blockage: branch RVO (BRVO) or central RVO (CRVO). BRVO is more common than CRVO.[5] It has been estimated that 16.4 million adults are affected by RVO worldwide, of which 2.5 million are affected by CRVO. This equates to a prevalence rate of 0.80 per 1000 for CRVO.[8]

According to the National Institute for Health and Care Excellence (NICE), in England and Wales, it has been estimated that for every 100,000 population, approximately 17 people aged 40 years or over will require treatment for macular oedema following CRVO annually.[2]

CRVO typically increases with age, with over 90 per cent of people with CRVO aged above 50 years. It occurs slightly more frequently in males than females and shows no racial preference. The impact of vision loss associated with CRVO can have a profound effect on vision-related quality of life. Patients may struggle with daily tasks, lose confidence and become increasingly dependent.[2]

About EYLEA

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.[1]
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.