SIFI has announced the conclusion of a phase 3 clinical trial aimed at demonstrating the noninferiority of Netildex gel administered twice daily (BID) vs. Netildex solution administered four times daily (QID) in the control of inflammation after cataract surgery.
The trial, 044/SI, was a multicenter international, prospective, controlled and double-masked study involving 180 patients undergoing cataract extraction by means of phacoemulsification with intra-ocular lens implantation.
In the 044/SI trial, Netildex Gel met its primary efficacy endpoint—number of patients with absence of cells and flare in anterior chamber—as well as all the secondary endpoints such as signs and symptoms of ocular inflammation, microbial load, intraocular pressure, ocular discomfort, visual acuity and safety.
The study also confirmed the optimal safety profile of Netildex, showing no differences between the two arms in terms of local tolerance and global safety.
Following the successful completion of the 044/SI trial, a Type II regulatory variation to the Netildex Gel marketing authorization was recently submitted to AIFA, the Italian Regulatory Agency.
“The clinical results we report today on the treatment of inflammation after cataract surgery provide further strong support to the compelling clinical profile of Netildex Gel,” Fabrizio Chines, SIFI Chairman and CEO, said in a company news release. “By leveraging on our proprietary drug delivery hydrogel platform, we are delivering meaningful innovation to patients, improving their ease-of-compliance with prescribed therapies, in a market segment characterized by a low level of investments from the industry.”