Catania, August 25, 2020 - SIFI, an Italian leader in ophthalmology, is pleased to announce the successful conclusion of a Phase 3 clinical trial aimed at demonstrating the non-inferiority of NETILDEX® gel administered twice daily (BID) vs. NETILDEX® solution administered four times daily (QID) in the control of inflammation after cataract surgery.
044/SI was a multi-center 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.” declared Fabrizio Chines, SIFI Chairman and CEO. “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.”
SIFI is the leading Italian ophthalmic company, focused on eye care since 1935 with the mission to improve people’s lives through meaningful innovation in eye care. SIFI designs, manufactures and markets innovative pharmaceuticals, medical devices and nutraceuticals.
Headquartered in Catania, Sicily, SIFI operates directly in Italy, France, Spain, Romania, Turkey and Mexico with a staff of more than 400 people worldwide. Since June 2015, SIFI is backed by the private equity 21 Invest to support the company’s international expansion and portfolio development strategy. More information available at www.sifigroup.com.
NETILDEX® is a fixed combination of dexamethasone and netilmicin indicated for the treatment of ocular inflammation of the anterior segment of the eye, postoperative and not, in presence or at risk of bacterial infection. NETILDEX® has been successfully launched in Italy, Romania, Turkey, Mexico and Lebanon. Marketing authorization applications are ongoing in several European countries. NETILDEX® is the first fixed combination product line available in single and multi-dose solution or single-dose hydrogel formulation. During the clinical development of the product, NETILDEX® has proved to be safe and effective in several Phase 3 clinical studies, cumulatively involving more than 1000 patients.
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