Alimera Sciences is “dedicated to change the paradigm of how we think about and subsequently treat diabetic macular edema (DME),” Mr. Myers said. Iluvien is a fluocinolone (corticosteroid) implant for the treatment of DME. One implant releases 0.2 mcg per day, giving patients up to 3 years’ worth of therapy. Iluvien is “a real advancement in the opportunity for quality of life of the DME patient” over the monthly or quarterly injections most DME patients need.
Getting Iluvien to market took more than 3 years in the U.S., but during that time, most researchers/clinicians came to realize there is an inflammatory component to DME along with a vascular component. When the company’s pivotal study, FAME, began in 2005, very little was known about DME but a decade later, the issue has become when to introduce steroids, not “if,” Mr. Myers said.
With Iluvien, patients rapidly improve their vision by month 3, and maintain those vision gains through 3 years. Roughly 30% of patients achieved a 2- or 3-line vision gain, representing a “significant improvement in quality of life,” Mr. Myers said.
Iluvien was launched in 2013 in the U.K., and in Germany and Spain in 2014. There are 14 additional countries that have granted marketing authorization. Alimera has inked licensing deals in Australia, Canada, and Israel, and has a distribution agreement in Italy. In the U.S., beginning in January 2016, clinicians will be able to use J-code J7313 for reimbursement.
Dan Myers is the Co-Founder, President, and CEO of Alimera Sciences, Inc.