The Austrian Agency for Health and Food Safety has issued marketing authorization to pSivida ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME).
The injectable, sustained-release intravitreal insert releases sub-microgram levels of fluocinolone acetonide (FAc) for up to 36 months for the treatment of chronic DME.
pSivida president and chief executive officer Paul Ashton said ILUVIEN has received marketing authorization and will soon be available to patients in Austria.
"We look forward to ILUVIEN receiving the additional expected EU approvals," Ashton added.
pSivida is developing an insert of the same design for the treatment of uveitis affecting the posterior of the eye, the company said.
