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Alimera allowed to reduce size of Iluvien study in UK

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The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has given final approval to reduce the size of Alimera Sciences’ post-marketing study of Iluvien, according to a company press release.

The study, originally intended to follow 800 patients over 5 years, has shown consistent positive safety data, leading the company to seek a smaller sample size, the release said. There are currently 550 patients enrolled.

“Since the beginning, the results we’ve seen in our post-marketing studies have mirrored, and often exceeded, the results in our FAME clinical trials,” Dan Myers, CEO of Alimera, said in the release. “From this, we concluded that we could potentially reduce the [Iluvien Registry Safety Study] sample size without compromising on the study objective, and MHRA agreed. In addition to cost and time savings, our ability to produce data sets on safety, efficacy and disease burden reduction earlier than expected allows us to share this data with our customers.”