pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, has announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) issued final draft guidance indicating that Iluvien is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
While Iluvienhas received marketing authorization in the UK, the independent Appraisal Committee concluded that the evidence provided did not show that the benefits Iluvienprovides to patients justify the proposed price.
pSivida's licensee, Alimera Sciences, reported that in response to the final draft guidance, it has immediately begun to develop a Patient Access Scheme (PAS) to address NICE's cost concerns. According to Alimera, the PAS being developed, if accepted, will make Iluvienavailable to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies.
The International Diabetes Federation estimates that more than three million people are currently living with diabetes in the UK, nearly 200,000 of whom, according to Alimera's estimates, suffer with vision loss from DME.
pSivida Corp., develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years.