The FINANCIAL — New data from the Phase 3 MYRROR trial of VEGF Trap-Eye (aflibercept solution for intravitreal injection) confirm the long-term success with VEGF Trap-Eye for the treatment of myopic choroidal neovascularization (mCNV), according to Bayer AG.
The results were presented during the American Academy of Ophthalmology (AAO) Conference in New Orleans.
Bayer HealthCare expects to submit the first application for regulatory approval for this indication in Asia before the end of 2013.
In the MYRROR trial, patients receiving VEGF Trap-Eye had a mean improvement in best-corrected visual acuity (BCVA) at week 24 of 12.1 letters from baseline, compared to a loss of 2 letters in patients receiving sham injections (p<0.0001), according to Bayer AG.
The efficacy gains seen at week 24 were maintained and even extended further in the VEGF Trap-Eye arm until week 48. Patients received in the first quarter of the study, i.e. from baseline to week 12, a median of 2 injections. In each of the following three quarters, the median of injections was 0. This underlines that the nature of the disease is such that it can be appropriately managed with short-term treatment and a very limited number of injections. Improvement in visual and anatomic outcomes were also seen in the sham group as both arms were eligible to receive VEGF Trap-Eye 2mg starting at 24 weeks; however, gains were less than those seen in patients in the VEGF Trap-Eye arm.
“Early and effective treatment options are urgently needed for patients with mCNV to avoid permanent vision loss,” said Kemal Malik, M.D., Member of the Bayer HealthCare Executive Committee and Head of Global Development. “These data show the disease may be successfully managed with an acute treatment regimen in the majority of subjects; however, it is still critical that treatment be administered early in the onset of the disease for maximum benefit to the patient,” Malik added.
VEGF Trap-Eye was generally well-tolerated throughout the full 48 weeks of this study. The most common adverse events observed in the MYRROR trial that occurred with a incidence >5%, and which have a higher incidence than sham, include nasopharyngitis, conjunctival hemorrhage, dry eye, eye pain, nausea, dizziness, headache. Adverse events were typical of those seen in other studies in patients receiving intravitreal anti-VEGF therapy.
VEGF Trap-Eye has been approved under the brand name EYLEA in Europe, the United States, Japan, Australia, and in many other countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD). EYLEA has also been approved in Europe for the treatment of visual impairment due to macular edema secondary to CRVO as well as in the U.S. and in selected countries in Asia and Latin America for the treatment of macular edema following CRVO.
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.
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