Iluvien, the insert delivering fluocinolone into the eye for diabetic vision loss, along with its licensee Georgia-based Alimera Sciences ($ALIM), is having a tempestuous few weeks. On the upside, Iluvien has been approved for the market in France and Germany, along with existing approvals in Austria, Portugal and the U.K. However, on the downside, NICE (the U.K.'s National Institute for Health and Clinical Excellence) has now released a draft recommendation that does not back the use of the sustained-release intravitreal implant for the treatment of visual loss caused by chronic diabetic macular edema (DME), saying that it just would not be cost-effective. This is a draft appraisal, and NICE expects to issue its final guidance in November.
According to Bloomberg, NICE stated that Alimera "underestimated the incremental cost-effectiveness" of Iluvien, adding that: "Unfortunately in this case, the [independent Appraisal Committee] agreed that the evidence provided could not support a positive recommendation."
However, another (potential) up--according to Iluvien developer pSivida ($PSDV)--Alimera is planning to resubmit its application to the FDA for U.S. approval of Iluvien, using data from two previously completed pivotal Phase III clinical trials (FAME Study). Alimera expects that these will address the issues that the FDA raised in its November 2011 Complete Response Letter (CRL) and in its recent meeting with the company, when the FDA said that it was unable to approve the new drug application because it did not provide sufficient data to support the implant's safety and efficacy in the treatment of DME.
Iluvien was developed by pSivida using its Durasert technology and licensed to Alimera in 2005 for the treatment and prevention of eye diseases in humans other than uveitis. Under the terms of the agreement, pSivida will receive 20% of profits, so the company has an ongoing stake in Iluvien's success. A lot is now hanging on the FDA's response--something to keep an eye on?
- read the press release
- check out the article in Bloomberg
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