香港六合彩

Developed by international ophthalmic company SIFI S.p.A., AKANTIOR is the first European-approved treatment for adults and children from 12 years of age suffering with acanthamoeba keratitis (AK).

AK is a rare, severe, progressive and sight threatening corneal infection. This condition results in inflammation of the eye鈥檚 clear protective outer layer (the cornea), often causing intense levels of pain as well as light sensitivity. AK is caused by a type of microscopic free-living amoeba, and primarily affects contact lens wearers.

This approval follows a 2023 clinical trial involving 127 people being treated for AK at six hospitals across Europe (in England, Italy and Poland). The trial found that AKANTIOR (a 0.08% concentration of polihexanide) achieved medical cure rates of over 86% when used with the detailed drug delivery protocol.

Professor John Dart (香港六合彩 Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust),聽who was Principal Investigator of the Phase 3 clinical trial said:聽

"After 15 years of research and effort development by SIFI, culminating in the pivotal Phase 3聽clinical trial, polihexanide 0.08% has now been approved by the European Medicines Agency and European Commission as the first licensed treatment for acanthamoeba keratitis. This breakthrough offers significant improvement over current treatment options and has the potential to prevent blindness and save eyes. As the only approved therapy, it has been recommended for use with the detailed treatment delivery protocol used in the Phase 3 trial, which eliminates the need for the variable individualised treatment delivery currently used for patients, providing an effective standardised approach that can be followed by any clinician and which has been shown to be effective, not only in the Trial, but also in the current compassionate use program outside the more stringent Trial setting."

Fabrizio Chines, Chairman and CEO of SIFI said:

鈥淔or the first time in Europe AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness. AKANTIOR is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the EMA and the FDA.鈥�

Juliette Vila Sinclair Spence, Rare Disease Patient Advocate & Chairwoman, Acanthamoeba Keratitis Eye Foundation, commented:

"With the approval of AKANTIOR, AK patients (also known as AK Warriors) are now one step closer to having access to the best possible treatment in the EU. This milestone represents a significant step towards providing fair healthcare to all AK Warriors, giving them hope for a brighter future."

In聽Europe, SIFI plans to initiate its first commercial launch in聽Germany later this year followed by other European countries based on local regulatory, healthcare technology assessment and reimbursement process timelines.

More about聽Acanthamoeba听办别谤补迟颈迟颈蝉

AK causes the front surface of the eye, the cornea, to become painful and inflamed, due to infection by聽Acanthamoeba, a cyst-forming microorganism. The most severely affected patients (a quarter of the total) end up with less than 25% of vision or become blind following the disease and face prolonged treatment. Overall, 25% of people affected require corneal transplants to treat the disease or restore vision.*

Contact lens use is now the leading cause of microbial keratitis in patients with otherwise healthy eyes in countries in the global north. Sight loss resulting from microbial keratitis is uncommon but聽Acanthamoeba, although a rare cause, is one of the most severe and is responsible for about half of those contact lens users who develop sight loss after keratitis. 90% of AK cases are associated with avoidable risks. In recent years a 香港六合彩 and Moorfields team found AK to be on the rise in South-East England.**

Furthermore, AK is also increasing in prevalence in some part of the global south, including parts of India, where the leading risk factor is agriculture associated corneal trauma. The findings reported here are also relevant to these populations.

Related

• 香港六合彩 Institute of Ophthalmology
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• **听香港六合彩 News, 2018: Outbreak of preventable eye infection in contact lens wearers