Alimera Completes Recruitment for the Synchronicity Study Evaluating Yutiq
Alimera Sciences announced that it has completed enrollment for the company’s Synchronicity study, a prospective, open-label clinical study evaluating the safety and efficacy of Yutiq (fluocinolone acetonide intravitreal implant 0.18mg) in the treatment of chronic noninfectious uveitis and related intraocular inflammation.
“We are pleased to reach the enrollment target for this phase 4 open-label study only a few short months after our acquisition of Yutiq,” Rick Eiswirth, Alimera’s President and Chief Executive Officer, said in a company news release. “We look forward to the initial readout from this study in the second half of next year to provide retina specialists with a broader sense of the utility of fluocinolone acetonide in a durable intravitreal implant across a variety of patients with chronic noninfectious uveitis affecting the posterior segment (NIU-PS). This could potentially benefit both Yutiq in the United States and Iluvien in Europe and the Middle East, where it is approved to treat chronic NIU-PS.”
The Synchronicity study is a multicenter, open label study evaluating Yutiq in chronic inflammation. The Synchronicity study currently has enrolled 110 patient eyes in approximately 25 sites around the US. Patients who meet the entry criteria receive Yutiq as an intravitreal injection in the designated study eye. The treatment period is 36 months, with data capture for this study being the first 24 months of Yutiq drug treatment.
The primary outcome measure for the Synchronicity study is the mean change from baseline in BCVA letter score in the study eye measured by EDTRS at Month 6 and the mean change from baseline central subfield thickness at Month 6. Key secondary endpoints include time to recurrence of noninfectious inflammation in the study eye; presence of vascular leakage at Months 1, 3, 6, 12, 18, and 24; proportion of subjects with resolution of macular edema at Months 1, 3, 6, 12, 18, and 24; mean change from baseline in BCVA letter score at Day 14 and at Months 1, 3, 12, 18, and 24; and mean change from baseline in CST at Months 1, 3, 12, 18, and 24. Full study details are available at https://clinicaltrials.gov.
Alimera also announced that Elliot Maltz has been named Chief Financial Officer effective immediately. Mr. Maltz began his career as an audit manager for Deloitte & Touche LLP before joining Sapient Corp. where he was the Technical Accounting and SEC Reporting Manager. Most recently he was the Chief Financial Officer with Orgenesis, Inc., a publicly traded global biotech company transforming the processing of cell and gene therapies.