pSivida reports that NICE issues draft guidance for use of ILUVIEN for pseudophakic patients with DME

Jun 15 2013

pSivida Corp. (NASDAQ:PSDV - News), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that the United Kingdom's National Institute for Health and Care Excellence (NICE) issued draft guidance recommending ILUVIEN® for the treatment of pseudophakic patients (those who have undergone prior cataract surgery) with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Following a rapid review by NICE, this recommendation proposes a change to the published guidance issued by NICE in January 2013 and takes into consideration a patient access scheme (PAS) submitted by Alimera.

“We are very pleased. If this recommendation becomes final, ILUVIEN will be available in the U.K. to pseudophakic as well as private pay and privately insured patients”

"We are very pleased. If this recommendation becomes final, ILUVIEN will be available in the U.K. to pseudophakic as well as private pay and privately insured patients," said Dr. Paul Ashton, Chief Executive Officer of pSivida. "The pseudophakic DME population represents a large subgroup as patients with DME have a far higher incidence of cataract than the overall population. In the Phase III FAME™ trials of ILUVIEN, over 50% of control patients were pseudophakic at the end of the trial."

The NICE Appraisal Committee making the recommendation confirmed the conclusions that ILUVIEN is clinically effective in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies as well as in the subgroup of pseudophakic chronic DME patients. Based on the PAS, the Committee concluded that the cost-effectiveness threshold had been met for the subgroup of chronic DME patients who are pseudophakic. NICE will issue final guidance after a comment period.

Professor Carole Longson, Health Technology Evaluation Center Director at NICE said, "Around 336,000 people with diabetes in the UK have diabetic macular edema... NICE is pleased to be able to recommend fluocinolone (ILUVIEN) for some people for the treatment of this condition in draft guidance." NICE will issue final guidance after a comment period.

"We are encouraged by Alimera's optimism that this recommendation will result in a change in the final published NICE guidance and by Alimera's plans to continue to work with NICE to seek to broaden access to ILUVIEN to include all chronic DME patients who could benefit from the treatment," added Dr. Ashton.