FDA grants priority review to Roche's filing for Lucentis in myopic choroidal neovascularisation

Roche's Genentech unit announced Tuesday that the FDA granted priority review to a filing seeking expanded approval of Lucentis (ranibizumab) to include the treatment of myopic choroidal neovascularisation (mCNV). The company noted that if authorised, Lucentis would be the first FDA-approved anti-VEGF therapy to treat the condition.

According to Genentech, the marketing application is based on data from the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT), the only treatment currently approved by the FDA for the condition. Results showed that after three months, patients in the two groups that were treated with Lucentis gained 10.5 letters and 10.6 letters in visual acuity, demonstrating a statistically significant improvement over the vPDT group, which gained 2.2 letters.

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Lucentis is currently approved by the FDA for the treatment of patients with wet age-related macular degeneration, macular oedema after retinal vein occlusion, diabetic macular oedema (DME) and diabetic retinopathy in people with DME. Genentech holds rights to the injectable therapy in the US, while Novartis has exclusive commercial rights for the rest of the world.

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