ATLANTA, GA — Alimera Sciences, Inc., a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announces 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 non-infectious 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,” said 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 non-infectious 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.”
About Synchronicity
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 U.S.
Patients who meet the entry criteria receive YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg 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 non-infectious 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.
About YUTIQ
YUTIQ is a sustained release fluocinolone acetonide intravitreal implant injected into the back of the eye using CONTINUOUS MICRODOSING™ technology, which is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for up to 36 months, to reduce the recurrence of disease and enable patients to maintain vision longer with fewer injections. YUTIQ helps provide CONTINUOUS CALM™ by reducing recurrence of inflammation in the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
About Alimera Sciences, Inc.
Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer.
Contact
Jules Abraham
for Alimera Sciences
917-885-7378
[email protected]