Novartis receives EU recommendation for Lucentis approval

Novartis has received a positive statement from the Committee for Medicinal Products for Human Use of the EU for the regulatory approval of Lucentis (ranibizumab), its treatment for patients with the neovascular, or “wet” form of age-related macular (AMD) degeneration.

Neovascular AMD is the main cause of loss of vision in the over-50s in the west. It is related to the growth of fragile pathological new vessels that leak fluid and blood under the middle part of the retina, with the development of scar tissue that destroys the macula if it is left untreated, affecting central vision in patients.

Ursula Schmidt-Erfurth, chairman of the department of ophthalmology at the university of Vienna, said: “With Lucentis, the future of wet AMD treatment is certainly brighter than ever.”

She added that the drug was a “real hope” to patients suffering with the disease, being the only treatment which has passed clinical trials showing an above-average incidence of the improvement of vision, enabling patients to regain their everyday independence by making it possible for them to cook, read and drive.

Research published in August revealed that 90 per cent of patients treated with Lucentis maintained vision, while 68 per cent of those treated had their vision enhanced by one or more letters in visual acuity and 40 per cent had their vision improved by 15 or more letters.