The first time the FDA took a close look at Alimera's application for Iluvien, regulators came back looking for 36-month safety and efficacy data. In its second take on Friday, the agency concluded that the data for the diabetic macular edema drug never added up to the kind of proof of safety and efficacy needed for approval and ordered up two more studies as a condition for approval. And by the time the dust had settled Friday afternoon, Alimera shares had collapsed, plunging 73 percent amid dour warnings from analysts.
Shares of pSivida ($PSDV), which provided the delivery tech for the program and is partnered on the program, lost half of their value.
Expressing some considerable surprise, CEO Dan Myers added that "based on extensive research with U.S. retinal physicians, we have learned that Iluvien's long-term sustained delivery treatment benefit is desired and that Iluvien has a manageable risk to benefit ratio. We continue to believe in Iluvien as a long-term effective treatment option for DME. We are committed to, and have the funds for, pursuing approval in Europe and for evaluating our options in the U.S."
What Alimera doesn't have, according to analyst Simos Simeonidis, is enough cash to mount two new trials. Calling the FDA's decision a "worst-case scenario," Simeonidis also is doubtful about Alimera's chances with the EU. "In addition, the mention of safety as a concern in the CRL is especially ominous," he adds, "since even if the company decides to invest the time and capital to run two more trials, we are not sure why these two trials may have a different outcome than the well-run, in our view, FAME program."