pSivida (NSDQ:PSDV) said the UK’s National Institute for Health & Care Excellence approved its Iluvien drug/device combination.
The approval is for cataract surgery patients who don’t respond to standard treatment for diabetic macular edema, according to a press release.
“We are very pleased with NICE’s recommendation, which is a key step in the availability of Iluvien for this typically large subgroup of chronic DME patients,” president & CEO Dr. Paul Ashton said in prepared remarks.
The win for Iluvien, which pSivida licenses to Alimera Sciences (NSDQ:ALIM), comes almost exactly a year after the British health regulator dealt a blow to the companies when it concluded that Iluvien is too expensive.
That decision led Alimera to create a "patient access scheme" for the non-responsive cataract surgery subgroup.
It hasn’t all been bad news, however, as pSivida and Alimera have logged wins in France and Germany. On this side of the pond, the FDA has rejected the Iluvien device 3 times, most recently in October.
PSDV shares were trading at $2.89 apiece as of about 10:40 a.m. today, up 2.5%.