Iluvien stumbles on rocky road to market in U.K.

In a blow to Iluvien's route to the market, the U.K.'s National Institute for Health and Clinical Excellence (NICE), the body providing guidelines for the National Health Service (NHS), has not recommended pSivida's ($PSDV) fluocinolone insert for the treatment of vision loss in diabetes in its final draft guidance.

Iluvien, developed using pSivida's Durasert technology, is an injectable microinsert that delivers fluocinolone to the back of the eye for up to three years and treats chronic diabetic macular edema (DME). Although Iluvien has been approved in the U.K., and a launch is planned for next year, according to NICE's final draft guidance, its benefits do not justify its proposed price. The decision is perhaps not entirely unexpected; in August, NICE's draft recommendation did not back the insert's use.

pSivida's shares have fallen 5%, but the company's CEO, Paul Ashton, did not seem surprised by NICE's decision. In an interview with Mass High Tech, he suggested that the $8,800 price proposed by Alimera Sciences ($ALIM), Iluvien's licensee, was more than he expected would be approved for reimbursement.

Alimera is putting together a Patient Access Scheme to address NICE's cost concerns. According to a statement from Alimera, this will "make Iluvien available to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies." The company estimates that around 6% of the U.K.'s 3 million diabetics have some degree of vision loss from DME.

Iluvien has been approved in Austria, France, Germany, and Portugal and is awaiting authorization in Italy and Spain, with launches in Germany and France planned for next year. However, in the U.S., Iluvien has been knocked back by the FDA twice, the latest in November 2011. This resulted in a 73% drop in licensee Alimera's share value and a loss of half of pSivida's share values, too. Alimera is planning a resubmission in the first quarter next year with data that it believes will meet the concerns that the FDA raised in its November 2011 Complete Response Letter and in a face-to-face meeting.

- read the press release from Alimera
- see the press release from pSivida
- check out the article in Mass High Tech