Medidur prevents posterior uveitis recurrence, yields small increase in IOP at 6 months

Additional analysis of 6-month data of a phase 3 clinical trial showed that there was a small average increase in IOP in eyes treated with Medidur, pSivida announced in a press release.

Mean IOP increased 1.8 mm Hg in the Medidur group compared with 0.7 mm Hg in the control group.

Through 6 months, 19% of eyes in the Medidur group required treatment with eye drops for elevated IOP compared to 18% of eyes in the control group.

“The average increase in IOP for Medidur-treated eyes was lower than that observed in the same period of the clinical trials for Ozurdex and Retisert, the two FDA-approved sustained release treatments for posterior uveitis,” Paul Ashton, PhD, president and CEO of pSivida, said in the release.

In addition, Medidur met its primary efficacy endpoint of preventing the recurrence of posterior uveitis for 6 months in the phase 3 trial, pSivida announced in an earlier release.

Medidur, an injectable micro-insert introduced into the back of the eye, provides a sustained release of 0.18 mg of fluocinolone acetonide at a controlled rate for 3 years. The micro-insert is the same that is used in Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences) for the treatment of diabetic macular edema.

The randomized, multicenter, double-masked clinical trial included 129 patients.

Six-month results showed that posterior uveitis recurred in 18.4% of eyes treated with Medidur and 78.6% of control eyes; the between-group difference was statistically significant (P < .00000001).

In addition, visual acuity improved by 15 letters or more from baseline in 23% of eyes in the Medidur group and 4.9% of control eyes (P = .011). Thirty-one percent of control eyes and 4.6% of eyes in the Medidur group lost 15 letters or more from baseline (P < .0001).

Of 65 patients who received systemic therapy at baseline, 52.4% of controls and 18.2% of patients in the Medidur group were still undergoing these therapies at 6 months (P < .01).

IOP was greater than 21 mm Hg in 27.6% of eyes in the Medidur group and 16.7% of controls. Of 64 phakic eyes at baseline, 9.5% of eyes in the Medidur group and 4.8% of controls required cataract surgery. These differences were not statistically significant.

pSivida is currently enrolling for a second phase 3 clinical trial for Medidur and will include up to 150 patients at about 15 centers in India.

The company plans to meet with the FDA next quarter to discuss data required for a new drug application planned for the first half of 2017. In addition, the company plans to file for European Union marketing approval based on data from the trial in late 2016, the release said.

Editor’s note: Additional information has been added to include data on IOP lowering and new information on pending trials.