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Alimera Sciences completes enrollment in phase 4 Synchronicity Study

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The study will evaluate the safety and efficacy of fluocinolone acetonide intravitreal implant 0.18mg, (YUTIQ) in the treatment of chronic non-infectious uveitis and related intraocular inflammation.

(Image Credit: AdobeStock/Worawut)

(Image Credit: AdobeStock/Worawut)

Alimera Sciences Inc has announced it has completed enrollment in its Synchronicity Study, evaluating the safety and efficacy of fluocinolone acetonide intravitreal implant 0.18mg, (YUTIQ) in the treatment of chronic non-infectious uveitis and related intraocular inflammation.

According to a release from the company, the study has enrolled 100 patients and will be a phase 4, open-label clinical study.

“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.”

YUTIQ is a sustained-release fluocinolone acetonide intravitreal implant injected into the back of the eye using continuous microdosing technology. According to the release from the company, microdosing technology 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.

References:
  1. Alimera Completes Recruitment for the Synchronicity Study. Press release; January 4, 2024. Accessed January 4, 2024. https://feeds.issuerdirect.com/news-release.html?newsid=5758305834881558
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