European committee recommends dexamethasone for noninfectious uveitis

MARLOW, U.K. — The Committee for Medicinal Products for Human Use has recommended extending the indication for dexamethasone in Europe to include the treatment of noninfectious uveitis, according to a press release from Allergan.

Ozurdex (dexamethasone 0.7-mg intravitreal implant, Allergan) is a biodegradable implant that delivers dexamethasone for up to 6 months. In a phase 3, multicenter, double-masked clinical trial, 229 eyes with noninfectious uveitis were randomized to receive 0.35 mg or 0.7 mg of dexamethasone or sham injections.

After 8 weeks, 47% of patients achieved a vitreous haze score of 0 after one injection of dexamethasone 0.7 mg compared to 12% of patients in the control group, according to the release.

Vitreous haze reduction correlated with improved visual acuity, and researchers observed a significant difference between the treatment groups from week 3 to week 26. In addition, patients in the treatment group showed a statistically significant improvement in visual function and vision-specific quality of life.

Ozurdex has been approved in Europe for the treatment of macular edema associated with retinal vein occlusion. If the implant is approved by the European Commission for noninfectious uveitis, Allergan plans to launch the new indication in the third quarter of 2011, the release said.