Roche Holding Ltd. (RHHBY) recently reported positive data from a late-stage study (RIDE) 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 24 month trial demonstrated that 33.6% of the patients who were on 0.3 mg of the drug and 45.7% 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 12.3% of patients who were on placebo. Roche added that the safety results were consistent with previous trials.
RIDE is the second of two pivotal trials being conducted by Roche to support the US approval of Lucentis for DME, the first being RISE. Results from the RISE study were reported last month.
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 recently received approval in the European Union for the treatment of visual impairment due to DME. The drug will be marketed by Novartis AG (NVS) in the EU.
Additionally, earlier during the month, Novartis received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lucentis’ approval for the treatment of visual impairment due to macular edema secondary to RVO in Europe.
Our Take
We note that at present 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.
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