Positive Data on Novartis' Lucentis

Zacks

Switzerland-based pharmaceutical company Novartis AG (NVS) recently announced positive data on Lucentis (ranibizumab), which showed that individualized treatment with the drug can improve eyesight even with a lower number of injections.

Novartis also presented positive data on Lucentis from a study (:REPAIR) conducted in with visual impairment due to choroidal neovascularization (:CNV) secondary to pathological myopia (PM).

The study, which was conducted with 65 patients, showed that 6 months of treatment with 0.5 mg Lucentis helped improve the mean visual acuity by twelve letters.

The study also showed that 29% of the patients did not require additional treatments after receiving the first injection.

Novartis plans to seek regulatory approval of Lucentis for myopic CNV in EU in the third quarter of 2012 and in Japan by year end.

The only approved medication for this indication is photodynamic therapy with QLT Inc.’s (QLTI) Visudyne (verteporfin).

In the RESTORE extension study, 240 patients suffering from diabetic macular edema (:DME) received an average of 13.9 injections of Lucentis individualized treatment for three years. Results demonstrated that about 19−25% of the patients participating in the study did not require further injections of Lucentis after the first year.

The study also confirmed the drug’s long-term efficacy and safety profile in patients with wet age-related macular degeneration (wet AMD) and DME.

Results showed that in order to maintain the mean visual acuity gained in the core study, an average of 3.7 injections and 2.7 injections were required in the second and third years, respectively. 

Meanwhile, the retrospective analysis of the LUMINOUS program, which currently comprises of more than 10,000 patients, reaffirmed the safety profile of Lucentis in wet AMD.

Lucentis is currently approved for wet AMD, visual impairment due to DME and visual impairment due to macular edema following retinal vein occlusion (:RVO). The drug was developed by Novartis in partnership with Roche Holdings Ltd. (RHHBY).

Roche holds the US marketing rights of the drug. In the second quarter of 2012, Novartis recorded Lucentis sales of $604 million, up 20% year over year in local currency.

Our Recommendation

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (Hold rating) in the short run.

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