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Seems you are very angry (and maybe justified). We are so fortunate to live in times we do. I recall my mother in-laws cataract surgery and her sight afterwards wasn't great. Nothing is a guarantee but for the majority of people advances in medical devices do prolong life and quality of life. Did you find anything specific? I do think USA and Canada have more controls than many places - why we don't have access to many premium lenses that Europe and Asia have and ones we have are much slower to market - like Symfony. It is broad too - mentioning many countries not just UsA and canada. Clicked on link to search a particular device but was unable to find anything specific to Symfony lenses. The prevalence of acanthamoeba keratitis has increased dramatically in recent years, accounting for 50% of contact lens-related blindness.Logan found the article - discusses many medical devices implanted (pacemakers, hip replacement among other things). Patients complain of pain and severe light sensitivity, and they are unable to work or lead normal lives until their symptoms resolve. The disease has developed resistance, causes impaired vision, blindness, or perhaps blindness, and frequently necessitates single or repeated corneal transplant treatments. Immediate medical action is essential to save the patient’s sight. “Avanzanite’s management team brings a substantial track record in delivering orphan medicines to niche European markets, which we expect will result in an accelerated return on investment for Sifi.”Īcanthamoeba Keratitis (AK) is a rare, severe, and progressive parasitic corneal illness caused by the free-living amoeba Acanthamoeba. As we advance towards a regulatory approval in dozens of European countries, we are excited to partner with Avanzanite, as this collaboration promises to accelerate access to our drug candidate to patients in several markets that are outside of our current commercial focus,” Fabrizio Chines, Sifi Chairman and CEO, said in a company news release. “We made significant investments on Akantior throughout 15 years of rigorous research and are looking for ways to maximize our asset’s potential. The completed phase 3 trial's detailed good results and fresh data were presented at the American Academy of Ophthalmology Annual Meeting in Chicago in October 2022. Sifi anticipates that the EMA Committee for Medicinal Products for Human Use will provide a favorable opinion in 2023. In May 2022, the European Medicines Agency (EMA) approved Sifi's Marketing Authorization Application (MAA) for Akantior. Sifi and Avanzanite also agreed to expand the existing Early Access Program (EAP) for the main five European nations to selected countries within the scope of Avanzanite's license.

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Sifi will continue to focus and invest in market access and commercial activities related to Akantior in existing and new European countries such as Italy, France, Germany, the United Kingdom, Spain, Romania, and Turkey, while also evaluating various options for Akantior commercialization globally, including potential license agreements outside of its core markets. The collaboration will provide commercial access to Akantior to an estimated 500 patients in these territories who suffer from acanthamoeba keratitis (AK) each year.

Sifi will manage all ongoing regulatory activities under the terms of the agreement, while Avanzanite will focus on market entry, distribution, and commercial activity in those markets. Italy-based Sifi formed a collaboration with Avanzanite Bioscience, a Dutch specialty pharmaceutical business, to commercialize and distribute Akantior (polihexanide) exclusively in 26 European Economic Area and Swiss countries.

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