Alimera Completes Enrollment for Synchronicity Study on Yutiq in Uveitis Treatment

Alimera Sciences has reached its enrollment target for the Synchronicity study, marking a significant milestone in the prospective, open-label clinical investigation of Yutiq (fluocinolone acetonide intravitreal implant 0.18mg).

 The study focuses on assessing the safety and efficacy of Yutiq in treating 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," stated Rick Eiswirth, Alimera’s President and Chief Executive Officer. "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 multicenter, open-label Synchronicity study has successfully enrolled 110 patient eyes across approximately 25 sites in the United States. Eligible patients receive Yutiq as an intravitreal injection in the designated study eye, with a treatment period spanning 36 months and data capture for the first 24 months of Yutiq drug treatment.

Primary outcome measures for the Synchronicity study include 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 cover various aspects, such as time to recurrence of noninfectious inflammation, presence of vascular leakage, resolution of macular edema, and changes in BCVA letter score and CST at specified time points.

In addition to this milestone, Alimera also announced the appointment of Elliot Maltz as Chief Financial Officer. With a background encompassing roles at Deloitte & Touche LLP, Sapient Corp., and Orgenesis, Inc., Mr. Maltz brings a wealth of financial expertise to Alimera Sciences in this critical leadership position.