Eyes On the Prize: From Sicilian Roots to FDA Approval


Historically, SIFI has been a modest local player focused on ophthalmic products, but in recent years the company has set some ambitious goals for itself—becoming a leading force in European ophthalmic markets, breaking into orphan drugs and adding value in the glaucoma field—and is now seeing its ambitions become a reality.


“SIFI is a small company with some significant innovations. Our growth will be based on launching innovative products in the most competitive markets and working with partners in the regions that are beyond our current capabilities,” says Fabrizio Chines, president & CEO.


Moving Into Europe

In the past, SIFI was focused on developing ophthalmic formulations principally for the Italian market, but the company has been aggressively extending its footprint into Europe. “SIFI has made a lot of progress towards that ambition, establishing direct operations in Spain, France, and Turkey; building on our strong foundations in Italy and Romania; and expanding our distribution network,” says Chines.

These markets have been carefully chosen to optimize opportunities: “We conduct a detailed analysis of the competitiveness of our portfolio against country-specific market conditions, potential competitors, as well as acquisition opportunities. Through these analyses, we were able to identify a small product acquisition opportunity in Spain, and a larger one in France, bolstering our own portfolio of products.”


An Orphan Drug on Track with EMA & FDA

Beyond its geographic expansion, the firm is currently in the process of registering an innovative orphan drug for acanthamoeba keratitis: “Our product, AKANTIOR, is on track to be approved by the EMA as an orphan drug for acanthamoeba keratitis. This is a devastating disease and SIFI’s product would be the first licensed product globally. The Phase III trial, which ended in 2021, gave a great efficacy and safety profile readout, and we plan to file in early May. This is a potentially transformational product for SIFI,” says Chines.

The United States is on SIFI’s radar as well: “AKANTIOR also has an orphan drug designation from the US FDA. We will consider options for commercialisation of AKANTIOR outside our core markets which include licensing and distribution, especially in the US.”


A Larger Focus on Glaucoma

In addition, Glaucoma has become a much larger area of focus for SIFI: “Glaucoma will be crucial to SIFI’s future growth story and – through internal development as well as external partnerships –we will be launching some differentiated glaucoma products in the next few months,” notes Chines.

Related Content

Latest Report