Roche Holdings Ltd. (RHHBY) recently reported positive data from two late-stage studies (RISE and RIDE) on its eye drug, Lucentis. The studies were conducted to evaluate the safety and efficacy of the drug in 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 trials demonstrated that the patients, after 24 months of treatment with Lucentis, experienced significant, rapid and sustained improvement in vision compared to those who were given placebo. Roche also confirmed that patients experienced an improvement in vision within seven days of starting treatment with Lucentis.
The company added that patients on Lucentis also experienced decreased retinal swelling. We believe that with the help of Lucentis, the patients can perform their daily activities such as reading and driving in a better manner, as compared to patients on placebo.
Roche plans to file a supplemental biologics license application (sBLA) with the US Food and Drug Administration (FDA) in the second half of 2011, to get Lucentis approved as a treatment for DME.
Currently, Roche markets Lucentis in the US for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO). The drug is approved in the European Union (EU) for the treatment of visual impairment due to DME and of visual impairment due to macular edema following RVO. The drug is marketed by Novartis AG (NVS) in the EU.
Our Take
We note that presently there are no drugs available in the US 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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