The Food and Drug Administration (FDA) has granted Roche's eye drug Lucentis a new indication, licensing it as a treatment for diabetic macular edema DME).
The eye condition causes blurred vision, severe vision loss and sometimes blindness in people with diabetes, and is thought to affect some 560,000 people in the US.
Roche's chief medical officer and head of global product development Hal Barron said: “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.”
The drug's safety and effectiveness in DME were established in two clinical studies involving 759 patients and measured the number who gained vision, as measured on an eye chart.
Results showed that between 34 per cent and 45 per cent of those treated with monthly Lucentis 0.3 mg gained at least three lines of vision, compared with 12 per cent to 18 per cent of those who did not receive an injection.
Renata Albrecht, director of the Division of Transplant and Ophthalmology Products in FDA's Center for Drug Evaluation and Research, said: “Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema.
“[This] approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”
But while the US regulator passed a 0.3mg dose of the drug, it declined Roche's request to approve a 0.5mg dose, concluding the higher dose provided “no additional benefit”.
Lucentis was first approved in 2006 to treat wet age-related macular degeneration (AMD) and also has a licence in macular edema following retinal vein occlusion.
Roche was keen to highlight that Lucentis is the first and only FDA-approved medicine for DME, but it will face some competition from another of the company's products.
The chemically similar – and much cheaper - cancer treatment Avastin (bevacizumab), has been used off-label in both DME and wet AMD.
Novartis, which has commercial rights to Lucentis outside the US, went to court in the UK to prevent doctors recommending Avastin instead of the NICE-approved Lucentis for wet AMD.
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