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Iluvien approved for new indication in UK

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The United Kingdom has added a new indication for Iluvien, approving it for the prevention of relapse in recurrent noninfectious uveitis affecting the posterior segment of the eye, according to a press release from Alimera Sciences.

Two 3-year, double- masked, prospective, sham-controlled studies of Iluvien (fluocinolone acetonide intravitreal implant) support the new indication.

The PSV-FAI-001 study, which included 129 patients, found Iluvien to be superior to sham. At 24 months, 40.2% of eyes treated with Iluvien had no recurrence of symptoms compared with 2.4% of patients who were treated with sham. Secondary outcomes show Iluvien-treated patients had less need for adjunctive systemic or immunosuppressant treatments, and the mean best corrected visual acuity change from baseline was greater than the change in those receiving sham, the release said.