Positive results for aflibercept for mCNV reported

June 12, 2013

Regeneron Pharmaceuticals Inc. and Bayer HealthCare reported positive top-line results for aflibercept injection (Eylea) from the phase III MYRROR study in myopic choroidal neovascularization (mCNV).

Tarrytown, NY and Berlin-Regeneron Pharmaceuticals Inc. and Bayer HealthCare reported positive top-line results for aflibercept injection (Eylea) from the phase III MYRROR study in myopic choroidal neovascularization (mCNV).

Patients receiving aflibercept at an initial dose of 2 mg, followed by treatment on an as-needed basis, had a mean improvement in best-corrected visual acuity from baseline at week 24 of 12.1 letters, compared with a loss of 2 letters in patients receiving sham injections (p < 0.0001).

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.

"Effective treatment options are urgently needed for patients with mCNV," said Kemal Malik, MD, a member of the Bayer HealthCare Executive Committee and head of global development. "We are pleased that the results of this study demonstrate that [aflibercept] may provide a treatment option for these patients."

In a related matter, The National Institute for Health and Care Excellence in the United Kingdom announced that aflibercept solution for injection should be recommended for the treatment of patients with wet age-related macular degeneration. Aflibercept is the first new medicine in ophthalmology to be fast-tracked to draft Final Appraisal Determination, without the need for additional consultation.

This decision means that eligible patients in England and Wales will have an alternative treatment available to them, which has been shown in two clinical studies to work as well as current treatment, but requires fewer hospital visits, reducing the burden for patients, relatives, and the National Health Service.

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