pSivida's Fluocinolone Insert Iluvien Get Negative Response in U.K. and U.S.
Iluvien, a fluocinolone insert for the treatment of vision loss in diabetes, developed using pSivida's Durasert technology and later its licensee was gained by Alimera Sciences, is an injectable microinsert which delivers the drug into the back of the eye for up to three years to treat chronic diabetic macular edema (DME). Iluvien has been approved in Austria, France, Germany, and Portugal and is awaiting authorization in Italy and Spain. It is planned to launch in 2013 in Germany and France.
Flowing such approval, Iluvien's planned to launch market in U.K. and the U.K.’s National Institute for Health and Clinical Excellence (NICE) supported its insert use in Aug., while this time NICE has not recommended in its final draft guidance which said Iluvien’s benefits do not justify the proposed price. In view of this, Alimera is organizing a Patient Access Scheme to address NICE's cost concerns which will "make Iluvien available to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies." according to a statement from Alimera. The company estimates that around 6% of the U.K.'s 3 million diabetics have some degree of vision loss from DME.
With the same dilemma, however, in the U.S., Iluvien has been knocked back by the FDA twice, the latest in November 2011 with some reasonable concern. This bought loss both for licensee Alimera and pSivida. Thus Alimera is planning a resubmission in the first quarter in 2013 with wanted data.