Roche Holding Ltd. (RHHBY) recently reported positive data from a late-stage study (RISE) of its eye drug Lucentis. The study is evaluating the safety and efficacy of the drug for treating patients suffering from diabetic macular edema (DME).
DME leads to swelling of the retina, in patients with type I or type II diabetes. The disease can cause blurred vision, severe vision loss and at times blindness.
Data from the 36 month trial demonstrated that after 24 months of treatment with Lucentis, 44.8% of the patients who were on 0.3 mg of the drug and 39.2% of the patients who were on 0.5 mg of the drug were able to read at least 15 more letters on the eye chart, as compared with 18.1% of patients who were given placebo. Roche added that an improvement in vision was seen within seven days of starting treatment with Lucentis.
RISE is the second of the two pivotal trials being conducted by Roche to support the approval of Lucentis for DME, the first being RIDE. Results of the RIDE study are expected in late 2011.
Currently, Lucentis is marketed in the United States for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion. Recently, Roche received approval from the European regulatory body to market Lucentis for the treatment of visual impairment due to DME. The drug will be marketed by Novartis AG (NVS) in the European Union.
Our Take
We note that at present there are no drugs available in the US market for the treatment of DME, and the approval of Lucentis for the indication will help boost Roche’s revenues. Presently, DME can be cured only through laser surgery.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
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