Safety of Novartis' Lucentis in VI-DME confirmed with new data; efficacy in CNV

New data revealed yesterday by Swiss drug major Novartis (NOVN: VX) showed that Lucentis (ranibizumab) has demonstrated improvement in visual acuity achieved with individualized treatment after one year is maintained for up to three years on average in patients with visual impairment due to diabetic macular edema (VI-DME), with fewer injections in years two and three compared to the first year and no additional or new safety risks identified.

Lucentis was developed by Novartis and Genentech, a subsidiary of Roche (ROG: SIX), which has the commercial rights to the drug in the USA, while Novartis has exclusive rights in the rest of the world. Lucentis generates annualized sales for Novartis of more than $2 billion from its currently approved indication of wet age-related macular degeneration (AMD). Last month, the US Food and Drug Administration approved Roche’s New Drug Application for Lucentis in DME (The Pharma Letter August 13).

The new findings come from the RESTORE extension study which showed that patients originally treated with ranibizumab on an individualised basis received an average of 13.9 injections over three years for VI-DMe patients. In the extension study, 19%-25% of patients, across all study arms, did not require any ranibizumab injections during years two and three. An average of 3.7 injections in the second year and 2.7 in the third year across the two ranibizumab arms were sufficient to fully maintain the mean of seven letters of visual acuity.