Genentech has announced FDA approval for Lucentis® as a treatment for patients with choroidal neovascularization (CNV) resulting from myopic macular degeneration (MMD), also known as myopic degeneration. Severe myopia (near-sightedness) can cause uncorrectable central vision impairment, and it may advance to total central vision loss from CNV, which is growth and leakage of blood vessels into the macula. Lucentis is the first FDA-approved anti-VEGF therapy to treat myopic CNV (mCNV) in the U.S.
The FDA approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to photodynamic therapy.
Sandra Horning, M.D. (chief medical officer and head of Global Product Development), said “With Lucentis, people with this condition now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision.”
Source: Genentech Press Release, 1/5/17