A U.K. regulatory body dealt a blow to pSivida (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) when it concluded that the Iluvien drug/device combination for chronic diabetic macular edema is too expensive.
The news sent both companies’ shares down today. ALIM stock was trading at $2.12 per share as of about 12:50 p.m. today, down 8.8%; PSDV shares lost 5.1%, trading at $1.30 apiece.
pSivida said the U.K.’s National Institute for Health & Clinical Excellence issued its final draft guidance for Iluvien, deciding that "the evidence provided did not show that the benefits Iluvien provides to patients justify the proposed price," according to a press release.
Alimera is working on a "Patient Access Scheme," in which pharmaceutical companies can arrange for special pricing agreements to lower the cost of drugs.
"According to Alimera, the PAS being developed, if accepted, will make Iluvien available to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies," according to the release.
The companies have had a hard time with Iluvien. The FDA last year rejected the drug/device combo for treating DME, saying Alimera hadn’t proven that its benefits outweigh its risks. The federal watchdog agency wants Alimera to run further clinical studies of Iluvien.