Article > US OKs Lucentis for DME, Avastin impresses in brain cancer

US regulators have expanded the scope of Roche and Genentech's eye drug Lucentis, granting it an additional approval to treat patients with diabetic macular oedema (DME).

DME is already a huge problem around the globe - estimated to affect more than 500,000 patients in the US alone - causing blurred vision, severe vision loss and sometimes blindness.

Lucentis (ranibizumab), which is marketed by Novartis outside of the US, has now become the first and only medicine to be approved by the US Food and Drug Administration to treat the condition, for which the standard of care to date has been laser eye surgery.

While helping to slow the rate of vision loss, laser surgery has only shown "limited ability" in restoring lost sight, Roche notes, and so the availability of Lucentis will be particularly welcomed by patients with the condition.

"For the first time, Americans with diabetic macular edema will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision," said Hal Barron, chief medical officer and head of Global Product Development at the Swiss firm.

Approval of the drug was based on data from the RIDE and RISE clinical trials carried out by Roche's subsidiary Genentech, which showed "substantial visual gain" for many patients with DME.

For example, results of the RIDE trial showed that 34% of patients who received Lucentis were able to read at least three additional lines (15 letters) on the eye chart at 24 months compared to 12% in the control group.

In the US Lucentis was approved for the treatment of wet age-related macular degeneration in 2006 and for macular edema following retinal vein occlusion in 2010.?

Avastin hits glioblastoma targets

Meanwhile, in further good news for Roche and Genentech, a Phase III trial of cancer drug Avastin (bevacizumab) in combination with radiation and temozolomide chemotherapy met one of its key targets by significantly improving progression-free survival (PFS) in patients newly diagnosed with glioblastoma.?

In addition, no new safety findings were observed in the trial, with adverse events found to be consistent with those seen in previous trials of drug across tumor types for its approved indications.?

Data from the Phase III AVAglio Study on overall survival - the other primary endpoint - are expected next year, the firms said.

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Source: http://www.pharmatimes.com/Article/12-08-13/US_OKs_Lucentis_for_DME_Avastin_impresses_in_brain_cancer.aspx

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