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pSivida’s Medidur maintains primary endpoint results at 12 months

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Medidur statistically significantly prevented recurrence of posterior uveitis through 12 months, pSivida announced in a press release.

Prevention of recurrence of disease was the primary endpoint in a 6-month phase 3 study, which was met with “high statistical significance” (P < .00000001) and which continued to be met through 12 months of follow-up in the current intent to treat analysis.

The phase 3 multicenter randomized trial included 87 eyes that received Medidur (sustained-release 0.18 mg fluocinolone acetonide implant) and 42 eyes that received a sham injection. Twelve-month results in those patients showed that posterior uveitis was likely to recur in 26.4% of eyes in the treatment arm compared with 85.7% of eyes in the control arm. IOP increased an average of 1.3 mm Hg in treated eyes and 0.7 mm Hg in control eyes. However, the incremental risk of IOP elevation in treated eyes was lower at 12 months than at 6 months.

Visual acuity improved 15 or more letters from baseline in 22.9% of treated eyes compared with 11.9% of control eyes.

Among phakic eyes, 45.2% of treated eyes and 9.5% of control eyes required cataract surgery at the last follow-up; 51.7% of treated eyes and 50% of control eyes had undergone cataract surgery before the study, the release said.

Of 65 patients who were using systemic steroids, immunosuppressants or biologics at baseline, 18.2% of treated patients and 52.4% of controls were still using those medications at 12 months.