Switzerland-based pharmaceutical company
) 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
The only approved medication for this indication is photodynamic
) 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
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,
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
Roche Holdings Ltd.
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.
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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