pSivida Corp. (PSDV) recently announced that the UK’s National Institute for Health and Care Excellence (NICE) has issued draft guidance where it recommends Iluvien for the treatment of pseudophakic patients with chronic diabetic macular edema (:DME) considered insufficiently responsive to available therapies.
The NICE Appraisal Committee said that Iluvien is effective in the treatment of vision impairment associated with chronic DME in patients who have insufficiently responded to available therapies and also in pseudophakic chronic DME patients.
Once this recommendation becomes final, Iluvien will be available in the UK to pseudophakic patients plus private pay and privately insured patients. This is a revision from the initial guidance issued by NICE in Jan 2013. It had earlier stated that Iluvien is not cost effective for the treatment of chronic DME. However, NICE now says that the drug meets the cost effective benchmark for use in pseudophakic patients with chronic DME.
Iluvien is approved in the UK, Austria, France, Germany, Portugal and Spain, while in Italy it has been recommended for approval.
As per NICE, around 336,000 diabetes patients in the UK also have DME.
We note that pSivida had collaborated with Alimera Sciences, Inc. (ALIM) to develop Iluvien for DME. The association between the two companies dates back to Feb 2005.
In the first quarter of 2013, Alimera resubmitted a New Drug Application (:NDA) for Iluvien in response to the second Complete Response Letter received in Nov 2011 from the US Food and Drug Administration (:FDA). The FDA will respond to the NDA by Oct 17, 2013.
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