Memorandum

Alimera Sciences re-submits diabetic macular edema treatment Iluvien to the FDA for the fourth time – April 2, 2014

Alimera Sciences announced late last week that it has submitted it/pSivida's diabetic macular edema (DME) treatment, Iluvien, to the FDA for the fourth time. Iluvien is an implantable device that releases fluocinolone acetonide (a corticosteroid). The FDA rejected the treatment in October 2013, and the announcement that Alimera released at the time noted that the complete response letter suggested a new 12-month trial to address safety concerns (concerns were unspecified in the company's announcement). The CRL also indicated that the FDA was open to attempting to identify a patient population in which the benefits outweighed the risks. Alimera's resubmission contains the company's responses to the FDA's safety concerns, including a safety update using commercial experience with Iluvien - this suggests that the company did not conduct the requested safety trial. We thought the trial would not be feasible for the small company who brought in only $1.9 million in revenue in 2013, all from Iluvien. Iluvien's one-time injection administration (lasting up to 36 months) gives it an advantage over currently available anti-VEGF treatments for DME (Roche/Novartis' Lucentis and Bayer's Eylea) that require injections roughly once/month (every other month after the first three months for Eylea); presumably the advantage is in terms of not only convenience and adherence, but also cost. The disadvantage of steroids, however, is the high frequency of side effects (cataracts, increase in intraocular pressure), which may have been some of the reason for the additional data. Iluvien is currently approved in Austria, the United Kingdom, Portugal, France, Germany and Spain and is on the market in the UK and Germany.