Results for VEGF Trap-Eye ( Aflibercept ophthalmic solution ) from the Phase 3 MYRROR study in myopic choroidal neovascularization ( mCNV ) were presented.
Patients receiving VEGF Trap-Eye at a dose of 2 mg had a mean improvement in best-corrected visual acuity ( BCVA ) from baseline at week 24 of 12.1 letters, compared to a loss of 2 letters in patients receiving sham injections ( p less than 0.0001 ).
VEGF Trap-Eye treatment was started with a single injection; additional injections were given only in case of newly occurring or persisting mCNV.
VEGF Trap-Eye was generally well tolerated. The most common adverse events observed in the MYRROR trial that occurred with a frequency of 2% or more were conjunctival hemorrhage, dry eye, eye pain, headache and nasopharyngitis.
VEGF Trap-Eye was approved under the brand name Eylea in the United States for the treatment of neovascular age-related macular degeneration ( AMD ) in November 2011 and for macular edema following central retinal vein occlusion ( CRVO ) in September 2012. Outside of the U.S. EYLEA has been approved for use in neovascular AMD in Japan, Australia, Europe, and several other countries.
MYRROR was a double-masked, sham-controlled trial that randomized 122 patients to receive either VEGF Trap-Eye 2 mg or sham. Patients in the active treatment arm received one initial 2 mg dose of VEGF Trap-Eye.
Patients were evaluated every 4 weeks and were eligible to receive additional VEGF Trap-Eye 2 mg intravitreal injections on an as-needed ( PRN ) basis, determined by visual and anatomic criteria, through 20 weeks. Patients on the sham arm received monthly sham injections through week 20. Starting at week 24, patients in both arms were eligible to receive VEGF Trap-Eye 2 mg on a PRN basis through week 44.
The primary endpoint of the study was the mean change at week 24 from baseline in best-corrected visual acuity ( BCVA ) as measured on the Early Treatment Diabetic Retinopathy Scale ( ETDRS ) eye chart, a standard chart used in research to measure visual acuity.
Myopic choroidal neovascularization is an acute disease of the retina where new, abnormal blood vessels grow into the retina in persons who are severely myopic ( typically more than 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 incite the development of choroidal neovascularization.
Severe myopia is particularly common in Asia. Myopic choroidal neovascularization is associated with high degrees of myopia and leads to progressive vision loss. Myopic choroidal neovascularization has a poor prognosis and, if left untreated, can, within approximately 10 years, progress to legal blindness in a majority of patients. In East Asia, the prevalence of myopia is significantly higher than in West Asia, and appears to have an earlier onset. In Japan, pathologic myopia is the second most common cause of blindness.
VEGF Trap-Eye 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.
VEGF Trap-Eye 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.
VEGF Trap-Eye is specially purified form of Aflibercept and contains iso-osmotic buffer concentrations, allowing for injection into the eye. ( Xagena )
Source: Bayer HealthCare, 2013