Courtesy of Benzinga.
Alimera Sciences (NASDAQ: ALIM) received a CRL from the FDA today, as the agency rejected Iluvien, a drug designed to treat diabetic macular edema. DME causes blurring in patients and results in further vision loss over time, making it difficult to focus. The disease primarily affects diabetes patients and causes severe swelling of the retina. While laser surgery has been the standard of treatment for over 25 years, Iluvien is injected into the back of the eye in a position that allows natural fluids to adequately absorb the medicine.
In December 2010, Alimera received a CRL from the FDA. The agency stated that the Iluvien application could not be approved in the present form, but did not ask for additional clinical trials. However, the FDA did request data from a Phase 3 clinical trial, as well as information from the Iluvien production and manufacturing process. The FDA also noted potential issues at two of Alimera’s third party manufacturers that are in the process of being resolved.
In the recent CRL, the FDA stated that Alimera did not provide sufficient data in the NDA to prove that Iluvien is safe and effective. It also concluded that data from the FAME clinical study showed side effects that were significant, and were not offset by the clinical benefits.
Surprisingly, Alimera was asked to run two new clinical trials to demonstrate whether Illuvien is safe and efficient, an odd development given that no such request was made in the last CRL. “We view this as the worst case scenario for Alimera,” said Cowan & Co analyst Simos Simeonidis. “The FDA decision translates into a multiyear delay and a very significant investment of capital that the company does not currently have on hand.”
The request of two new trials could be the death knell for Alimera, as the company does not have any more products in the pipeline. The company plans to apply for approval in Europe, and expects to receive a decision in the first half of 2012. Alimera’s CEO Dan Myers was noncommittal to the future of Iluvien in the US. “We are committed to, and have the funds for, pursuing approval in Europe and for evaluating our options in the United States.”
Phase 3 trials showed that visual clarity improved by 3 lines in a standard eye vision test. Patients showed statistically significant improvement during Week 3 of treatment. Unfortunately, 18.4% of patients displayed an increase in intraocular pressure, one adverse reaction to Iluvien. Ken Green, the company’s CSO, does not believe the figure was not that significant.
Despite the large setback, the market potential for a DME treatment is fairly large, at roughly $1.5 to $4 billion in the US, with a similar sized market in Europe. While Alimera may face difficulties in getting Iluvien approved on its own, it may need to find a partner to help fund the clinical trials that the FDA has asked for.
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