SIFI Secures European Patent and Launches AKANTIOR® in Germany
SIFI Secures European Patent and Launches AKANTIOR® in Germany
SIFI, an innovative leader in the ophthalmic field, is proudly announcing its latest achievements in the treatment of serious eye infections. The company has successfully obtained a Notice of Allowance from the European Patent Office for the formulation of polihexanide, a key component used in the treatment of acanthamoeba keratitis and fungal keratitis. This step enhances their intellectual property coverage and opens new markets for their pioneering treatments.
Details of the Patent Grant
The newly granted patent, which is cataloged as EP4216966, offers vital intellectual property protection that will remain effective until 2040. The impressive formulation of polihexanide, already patented in specific regions earlier, showcases SIFI's commitment to innovation within the ophthalmic realm. With this new patent, SIFI aims to extend its reach globally, as they are working on obtaining additional patents in multiple countries around the world.
Clinical Trial Breakthroughs
Recently, SIFI completed Phase 3 clinical trials for its flagship product AKANTIOR® (polihexanide 0.08%), achieving an astonishing 86% clinical resolution rate for acanthamoeba keratitis after an average period of about 4 months. The trials showcased a new dosing regimen, illustrating significant improvement in the quality of life for patients, making treatment more manageable and efficient.
Commercial Launch of AKANTIOR®
Following the successful marketing authorization for AKANTIOR® in Europe, SIFI is excited to announce that the product will be commercially available in Germany starting in October. This launch signifies a key milestone for the company, allowing them to establish a direct presence in Europe's largest pharmaceutical market. Plans for expansion into other European countries are already in the works, depending on local access and reimbursement timelines.
The Impact of AKANTIOR®
AKANTIOR® is groundbreaking, being the first approved treatment for acanthamoeba keratitis worldwide. The formulation effectively targets both phases of the acanthamoeba protozoan and is designed for easy daily use as a single-dose eye drop. This innovation underscores SIFI’s dedication to providing high-quality ophthalmic care that significantly improves patient outcomes.
Understanding Acanthamoeba Keratitis
Acanthamoeba keratitis is an ultra-rare yet severe corneal infection often experienced by individuals who wear contact lenses. The symptoms can be debilitating, leading to intense pain and severe light sensitivity, ultimately affecting the quality of life. Urgent treatment is critical, as untreated cases may lead to blindness or require corneal transplants.
About SIFI
SIFI, headquartered in Italy, is a premier international company in the ophthalmic sector. With a strong focus on research, development, and manufacturing, their mission is to enhance lives through innovative eye care solutions. Established in 1935, the company exports to over 40 countries, ensuring access to their groundbreaking products across major global markets. Their focus remains on delivering effective treatments to challenging medical issues in the ophthalmology field.
Frequently Asked Questions
What is SIFI's recent patent about?
SIFI's recent patent pertains to the formulation and use of polihexanide for treating acanthamoeba keratitis and fungal keratitis.
When will AKANTIOR® be available in Germany?
AKANTIOR® will be commercially launched in Germany in early October.
What are the results of the clinical trials for AKANTIOR®?
The Phase 3 clinical trials demonstrated an 86% clinical resolution rate for patients treated with AKANTIOR®.
Who can benefit from AKANTIOR®?
This treatment is primarily designed for individuals suffering from acanthamoeba keratitis, especially those who wear contact lenses.
What is SIFI's mission?
SIFI aims to improve lives through innovation in eye care, focusing on research and development in ophthalmic solutions.
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