The European Committee for Medicinal Products for
Human Use (CHMP) has recommended aflibercept solution for injection into
the eye for the treatment of visual impairment due to myopic choroidal
neovascularization 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.
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.
Myopic choroidal neovascularization (mCNV) is a
disease of the retina in persons who are severely myopic (typically at
least minus six diopters) and have pathological changes in the back of
the eye. The disease is characterized by an abnormally elongated eye
with a physical stretching of the sclera, choroid and retina, resulting
in degenerative and progressive changes. These degenerative changes can
induce the development of choroidal neovascularization. Anti-VEGF
therapy has already been shown to be effective in the treatment of wet
age-related macular degeneration (wet AMD), which is also characterized
by an acute growth of new, abnormal blood vessels in the retina.
