Lucentis receives DME approval in the EU

Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its therapy Lucentis for the treatment of patients with diabetic macular oedema (DME).

The company had supporting data from two clinical trials, RESTORE and RESOLVE, which demonstrated that Lucentis provided rapid and sustained visual acuity gains in comparison with sham or laser therapy.

David Epstein, division head of Novartis Pharmaceuticals, commented, "Lucentis was designed specifically for use in the eye, and its efficiency and safety have now been demonstrated in patients suffering loss of vision due to diabetic macular oedema through a robust programme of clinical trials."

In addition to the company supported clinical trials, a further study conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) also demonstrated gains in visual acuity after two years of treatment with Lucentis.