Alimera Sciences, Inc.’s (ALIM) long wait ended when the FDA finally approved Iluvien for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids. A clinically significant rise in intraocular pressure (IOP) was not witnessed in the patients.
Alimera stated in its press release that following the FDA’s decision, Iluvien becomes the first long-term treatment to gain approval for DME in the U.S. Alimera plans to launch Iluvien in the U.S. in the first quarter of 2015.
We note that the path leading to the FDA approval for Iluvien has been anything but smooth for Alimera. In Oct 2013, the company received the third Complete Response Letter (CRL) from the FDA on Iluvien. Subsequently, Alimera responded to the questions raised in the CRL. Alimera addressed issues related to the manufacturing facility and provided a safety update to the regulatory body. Subsequently, the company resubmitted the New Drug Application (NDA) for Iluvien in Mar 2014.
Alimera had in-licensed Iluvien from pSivida (PSDV) in Feb 2005. As per the agreement, Alimera holds the worldwide rights to develop and sell Iluvien. With this approval, pSivida stands to receive a $25 million milestone payment from Alimera. pSivida is also eligible to receive 20% of net profits on U.S sales of Iluvien.
Currently, Iluvien is marketed in the U.K. and Germany. Moreover, the drug has received marketing approval in Austria, Spain, Italy, Norway and Denmark.
Meanwhile, Alimera intends to launch Iluvien in France and Portugal by Dec 31, 2014. The company is currently seeking approval for the drug in eight additional EU countries for the treatment of vision impairment associated with chronic DME for patients who have responded insufficiently to available therapies.
We are pleased with the FDA approval of Iluvien with a broad label. This will boost the drug’s sales potential. We expect investors to react positively to the news.
Investors looking for well-ranked stocks in the health care sector can consider Cambrex Corp. (CBM) and Gilead Sciences Inc. (GILD). Both stocks carry a Zacks Rank #1 (Strong Buy).
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