2023-11-20 14:33:23
Extremely high sensitivity to light and excruciating pain. These are some symptoms of acanthamoeba keratitis, an ultra-rare serious parasitic eye infection (affecting 1-4 patients per million inhabitants per year) which, if not treated in time, progresses inexorably, up to corneal transplant or enucleation of the eye.
Incorrect use of contact lenses is the main risk factor (85% of cases). It has no particular correlation with age, but such patients experience a substantial and permanent deterioration in the quality of vision and life, making independent living impossible. There are currently no approved therapies worldwide for the treatment of acanthamoeba keratitis. However, an eye drop based on polyhexanide is Italian and is a candidate to be the first orphan drug approved for the treatment of the pathology in the world, and will be produced in the factories of Sifi, a pharmaceutical company based in Catania.
“Its high concentration single-dose formulation (0.8 mg/ml) makes its use in monotherapy possible – Fabrizio Chines, President and CEO of Sifi Spa, told time.news Health – Sifi has dedicated itself to the development of the drug based of polyhexanide, 0.08% mg/ml, over 13 years of research and invested significant resources through preclinical studies and clinical trials from Phase 1 to Phase 3 which recently concluded, with a cure rate of approximately 85% , which must be compared with the so-called standard of care, or rather, best supportive care, i.e. the use of other agents or off-label drugs which in the literature have led to the resolution of the infection in only 60% of cases”. The consequences of a wrong treatment “or of a lack of treatment – he adds – can lead to a cornea transplant rather than the loss of the eye. We are currently in the registration phase, we expect approval from the European Medicines Agency (EMA) in the first half of 2024″.
But who can access the drug? “Before even having approval, the company activated compassionate use programs in various European Union countries – underlines Chines – We are very proud to be able to allow around 100 patients from 10 European countries to have free access, through the requests coming from centers of excellence, to the drug which has demonstrated during clinical trials, but also through real world evidence and therefore the experience gained by doctors and patients, to be effective as well as safe”. Since it is an infectious pathology, “the therapy is acute – highlights Chines – and in our Phase 3 study an average duration of treatment of 4 months for clinical resolution was demonstrated”.
Prevention is fundamental. “Contact lens wearers above all must be careful to adopt rules of hygiene and behavior in line with the ophthalmologist’s instructions and avoid creating environments conducive to contamination that could give rise to this very serious pathology”. But Sifi’s commitment is not limited to the treatment of acanthamoeba keratitis – assures the president and CEO of the group – We are also dedicating our research to the development of a therapy for another rare pathology, fungal keratitis, whose prevalence it is similar to that of acanthamoeba keratitis.” The polyhexanide-based eye drops “has already received orphan drug designation also in the indication of fungal keratitis in the United States. At the moment we are in the preclinical phase, so we are continuing to invest in this active ingredient and in the medicinal product so that it can also be available for patients suffering from this other pathology” he concludes.
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