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pSivida Corp.
PSDV, a leader in developing sustained release,
drug delivery products for treatment of back-of-the-eye diseases, announced
today that the United Kingdom's National Institute for Health and Clinical
Excellence (NICE) has published final guidance indicating that ILUVIEN^® is
not cost effective for the treatment of chronic diabetic macular edema (DME)
considered insufficiently responsive to available therapies. This final
guidance is consistent with the final draft guidance issued on November 29,
2012.
pSivida's licensee for ILUVIEN for DME, Alimera Sciences, Inc., reported that
it has chosen to pursue a Patient Access Scheme (PAS) for ILUVIEN for DME that
is intended to allow treatment decisions to be based on patient need, rather
than cost. Alimera further reported that the PAS is currently under review by
the Patient Access Schemes Liaison Unit (PASLU) at NICE and that, if approved
by the Department of Health, the PAS will be available to the Appraisal
Committee for review and consideration. Alimera stated its belief that the PAS
could be considered under NICE's rapid review facility should the PAS be
accepted.
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