After a submission to 7 European countries in July 2010, Georgia-based Alimera Sciences has been granted approval in France for Iluvien, the sustained release intravitreal implant for the treatment of visual loss caused by chronic diabetic macular edema (DME) that cannot be treated by other means. The product has also been approved in Austria, Portugal and the U.K., and its first launches are planned for 2013.
"Iluvien has now been granted marketing authorizations in four of the 7 EU countries in which we have applied. We are continuing to work with regulatory authorities in Germany, Italy and Spain," said Dan Myers, president and CEO of Alimera Sciences.
Iluvien, developed by pSivida ($PSDV) using its Durasert technology and licensed to Alimera, releases fluocinolone acetonide into the back of the patient's eye for up to 36 months, and is inserted using a needle that creates only a small, self-sealing wound in the eye. According to the International Diabetes Federation, there are more than 4.3 million people living with diabetes in France, and Alimera estimates that this includes more than 220,500 people with vision loss associated with DME.
"I have seen the impact that chronic diabetic macular edema has on my patients and am pleased that a new therapy option will be introduced for use when current treatments have failed," said Gisele Soubrane of University Paris Descartes.
Licensee Alimera has submitted Iluvien in the U.S., but this was rejected for the second time in November 2011, and further data was requested, knocking shares down 73%; pSivida's shares also took a knock at the time. To fund the product's further development and commercialization, including its launch in Europe, Alimera has agreed to sell $40 million of Series A convertible preferred stock to institutional investors, including Palo Alto Investors, Sofinnova Ventures and New Enterprise Associates. Garheng Kong, managing member of Sofinnova Venture Partners, will join the board.
pSivida has received approval in the U.S. to carry out two Phase III trials of a fluocinolone acetonide micro-insert for the treatment of posterior uveitis, an inflammatory disease of the eye. Alimera has no rights to the treatment in this indication.
Editor's note: This story has been updated to state that Alimera submitted Iluvien in the U.S., not pSivida, and to confirm that pSivida retains rights to the posterior uveitis indication.