FDA approves Genentech’s Lucentis

Lucentis was specifically developed for intraocular use in the eye to treat the underlying cause of ‘wet’ age-related macular degeneration (AMD) by targeting the molecular pathway that controls the formation of new blood vessels. Lucentis is designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels).

Nearly all patients (95%) treated with Lucentis maintained their vision in phase III clinical trials that supported the approval. Vision improved by at least three lines (or 15 letters) on the study eye chart in up to 40% of these patients at one year.

Lucentis (ranibizumab injection) 0.5mg is recommended for intravitreal injection once a month. If monthly injections are not feasible, treatments can be reduced to one injection every three months after the first four monthly injections.

“In my opinion, the Lucentis approval stands out as one of the most important medical developments in ophthalmology during my 25 years in the field because it has the potential to reverse vision loss associated with wet AMD,” said Dr Eugene de Juan, president of the American Society of Retina Specialists. “We are pleased that Lucentis has been approved by the FDA.”