Roche’s eye drug, Lucentis, appears to treat diabetic’s vision loss

Hannah Blake

pharmaphorum

Lucentis, made by Roche unit Genentech, is currently waiting for approval from the US FDA for expanded use, as the global pharmaceutical company hopes to widen its options for people with diabetic macular edema (DME). DME is the most common cause of moderate vision loss in patients with diabetes and there are currently no FDA-approved drugs to treat it.

Lucentis has already been approved by the FDA to treat wet age-related macular degeneration and for macular edema following retinal vein occlusion. In clinical trials, Lucentis helped patients see at least 15 extra letters on an eye chart, which was the primary goal of the study, according to FDA reviewers. Patients who tested the higher dose of Lucentis were also able to sustain the improvement in vision for at least 24 months, while those who took the 0.5mg dose lost a bit of vision after the 18th month.

Staff at the US FDA reviewed Lucentis ahead of an advisory panel of outside experts on the 26th July who will vote as to whether or not to recommend approval of an expanded use of the drug, which is administered monthly by injection. They have asked advisers to consider whether both doses of the drug are equally safe and effective, and should be approved.

Around 75,000 new cases of DME are estimated to develop among Americans every year. If the FDA does approve Lucentis, it will likely compete with a drug being tested by Regeneron Pharmaceutical’s as well as Roche’s own cancer drug, Avastin, which works in a similar manner.

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Related news:

Roche’s Lucentis Works to Treat Vision Loss from Diabetes (Biospace)

FDA staff say Roche drug helped diabetics see (Reuters)

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