Alimera Sciences completes patient enrollment for phase 4 Yutiq Synchronicity study
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Alimera Sciences has completed enrollment for its Synchronicity study, a prospective, open-label trial to evaluate the safety and efficacy of Yutiq for chronic noninfectious uveitis and related 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 CEO, said in a company press release.
Yutiq is a sustained-release 0.18 mg fluocinolone acetonide intravitreal implant that uses continuous microdosing technology, designed to release sub-microgram levels of fluocinolone acetonide for up to 36 months, the release stated.
The study surpassed its initial goal of 100 patients, enrolling 110 patient eyes from 25 sites throughout the U.S. The primary endpoints are mean changes from baseline to 6 months in best corrected visual acuity letter score and central subfield thickness, while secondary measures include time to recurrence of noninfectious inflammation, presence of vascular leakage and resolution of macular edema.
“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,” Eiswirth said in the release.
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