Netildex gel meets primary endpoint
A phase 3 trial demonstrated noninferiority of Netildex gel twice daily compared with solution four times daily to treat ocular inflammation after cataract surgery, according to a press release from SIFI.
The multicenter, international, prospective, controlled, double-masked 044/SI study included 180 patients who underwent phacoemulsification with IOL implantation and were treated with either the gel or solution fixed combination of dexamethasone and netilmicin.
Absence of cell and flare in the anterior chamber, the primary endpoint, was met with the gel formulation.
No safety differences were seen between the two arms of the study.
Netildex is available in Italy, Romania, Turkey, Mexico and Lebanon, and SIFI has applied to the Italian Regulatory Agency for regulatory variation of the Netildex gel marketing authorization.