A drug candidate based on pioneering UCL and Moorfields Eye Hospital research and currently under development by SIFI SPA, has been shown to be highly effective in treating a rare sight-threatening eye infection in a new international clinical trial.
Results, published OphthalmologyDescribe the efficacy and safety of the first drug candidate for treatment Acanthamoeba keratitis (AK), applying a novel and evidence-based treatment protocol.
AK is a type of microbial keratitis (corneal infection) – a condition that causes inflammation of the cornea (the clear protective outer layer of the eye). AK can cause extreme pain as well as sensitivity to light.
AK is relatively uncommon, affecting one in 37,000 contact lens wearers in the UK each year, but accounts for around half of vision loss in this group. Contact lens wearers face an increased risk of disease; A UCL and Moorefields team recently found that people who wear reusable contact lenses face almost four times the risk of daily disposable wearers, while showering with the lenses and wearing the lenses overnight each increase the risk more than threefold.
The treatment being studied, low-concentration polyhexanide (PHMB 0.02%), first compounded and used to treat AK in the 1990s, was introduced by a team co-led by the lead author of this latest study, Professor John Dart, and It is highly recommended. Treatment for AK, but it is not a licensed drug, and treatment results are variable.
Acanthamoeba Keratitis can be prevented by following safe use advice for contact lens users: use daily disposables if possible, wash and dry hands before handling lenses, maintain good hygiene of lenses and contact lenses, and do not. Use them while bathing, swimming or showering or use goggles and renew the lens after use, do not wear them overnight and do not use them daily.
Unfortunately, when the disease develops the course is prolonged, and in the recent past, a third of patients had poor vision with a quarter requiring surgery at some stage.
PHMB 0.02% is an effective and widely recommended unlicensed therapy, but many clinicians have difficulty accessing it, formulation errors can sometimes lead to poor outcomes, and the lack of a proven treatment protocol has led to wide variation in how the drug is used. . In the treatment results. We expect that our new robust results with polyhexanide 0.08% will be a game changer for AK treatment, improving access and consistency of treatment, meeting currently unmet patient needs.”
Professor John Dart, UCL Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust
A phase 3 randomized controlled double blind clinical trial followed a phase 1 trial in healthy volunteers showing that a significantly higher concentration (0.08%) of polyhexanide was safe to use. The phase 3 trial was conducted in accordance with the scientific advice of the European Medicines Agency and compared the efficacy and safety of a high concentration of polyhexanide (0.08%) as monotherapy with a widely used dual therapy combining a low dose of PHMB (0.02%). with propamidine. All trials were sponsored and financed by the Italian pharmaceutical company SIFI with partial co-financing by the European Commission.
The study involved analysis of 127 people treated for AK at six hospitals in Europe (England, Italy and Poland).
The researchers found both formulations to be highly effective when used with a detailed drug delivery protocol, with a cure rate of 110/127 (87%) overall and for each treatment individually, meaning 87% of people were cured of AK without the need for surgery. One of the highest reported for The treatment failure rate was 17/127 (13.4%), with almost half requiring therapeutic corneal transplant surgery. The overall transplant surgery rate of 8/127 (6.3%) is the lowest reported in any case series of AK.
Researchers say the widely recommended dual therapy was more effective than usual in this trial because doctors were strictly following a set treatment protocol. In addition, new monotherapy has advantages over dual therapy, as simplicity reduces the risk of practice errors.
Dr. Vincenzo Papa (SIFI’s Head of Scientific Affairs) and co-author of the study said: “This publication Ophthalmology, the leading peer-reviewed journal in our field, further encourages our continued efforts to make polyhexanide 0.08% (Akantior®) available as the first approved orphan medicinal product for AK patients. Given the extreme disease burden and high unmet treatment need, we are proud of the high efficacy results in the robust setting that the trial produced, especially when compared to the 60% efficacy rate reported with current best treatments.”
Based on an extensive quality, preclinical and clinical data package of 15 years of research, SIFI is now seeking regulatory approval for 0.08% polyhexanide in Europe, the UK and the US.
Juliet Villa Sinclair Spence, Rare Disease Patient Advocate and Chairwoman, Acanthamoeba Keratitis Eye Foundation, commented: “Exciting news! AK Warriors (aka patients) are now one step closer to receiving a product for the first time with a standardized protocol. Acanthamoeba Keratitis It’s starting to bring light to the end of the tunnel.”
more about Acanthamoeba Keratitis
AK causes the front surface of the eye, the cornea, to become painful and inflamed, which is due to infection Acanthamoeba, a cyst-forming microorganism. The most severely affected patients (a quarter of the total) have less than 25% vision or become blind after the disease and face prolonged treatment. Overall, 25% of sufferers require a cornea transplant to treat the disease or restore vision.
Contact lens use is now the leading cause of microbial keratitis in otherwise healthy eye patients in northern countries worldwide. Vision loss as a result of microbial keratitis is uncommon Acanthamoeba, although a rare cause, is the most serious and accounts for about half of contact lens wearers who develop vision loss after keratitis. 90% of AK cases are associated with avoidable risks. In recent years a UCL and Moorfields team has looked at the growth of AK in South East England.
Furthermore, the prevalence of AK is also increasing in parts of the global south, including parts of India, where the main risk factor is agriculture-related corneal trauma. The findings reported here are also relevant to this population.