CHMP reccomends Bayer’s Eye medicine for approval in EUSeptember 25, 2015
The European Committee for Medicinal Products for Human Use (CHMP) has recommended Bayer’s aflibercept solution for injection into the eye for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV) for approval in the EU.
Myopic CNV is a disease of the retina associated with high degrees of myopia (near-sightedness) and frequently affects people of working age. It is a common cause of blindness in near-sighted subjects worldwide, as explained by Bayer.
“If left untreated, myopic CNV has an extremely poor prognosis resulting in blindness in the affected eye within a few years,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
“A treatment option that could not only prevent permanent vision loss, but also improve visual acuity would have great benefits for patients with myopic CNV.”
Bayer provides that the CHMP’s positive recommendation is based on the results of the Phase 3 MYRROR study in patients with myopic CNV. Patients receiving aflibercept solution for injection had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, while patients receiving sham injections lost two letters (p<0.0001), as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard instrument used in medical research to measure visual acuity. The efficacy gains seen at week 24 were maintained and even extended further in the aflibercept arm until week 48.