Alimera Sciences announced that the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has given final approval to reduce the size of its Iluvien Registry Safety Study (IRISS).
A post-marketing study, IRISS was originally designed to follow 800 Iluvien patients over 5 years. However, consistently positive real-world safety data from IRISS and other post-marketing studies led Alimera to seek a smaller sample size. Alimera enrolled the 550th patient in January of this year, making the anticipated last patient, last visit date January 2020.
"We are very pleased to receive final approval from MHRA to complete enrollment in IRISS as it stands today," Dan Myers, CEO of Alimera, said in a news release. "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. From this, we concluded that we could potentially reduce the IRISS 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."