In summer, there is a higher risk of parasitic eye infection. The first sight-saving drug but it is not accessible in Italy

They call them the “AK” warriors, they are the patients, especially young people, affected by Acanthamoeba keratitis, a rare disease but with a very common risk factor, especially in summer, due to the incorrect use of contact lenses and very dangerous for sight, with devastating effects up to the loss of the eye. Life is turned upside down because the excruciating pain is combined with photophobia and the only alternative is to stay at home in the dark for months.

“Until recently, these patients had little or no therapeutic options, and were treated as best they could using galenic preparations or off-label products, lacking scientific data on efficacy and safety and standardized treatment protocols. It was not just a problem of available therapies, but also of treatment methods: patients were forced to use two or three eye drops every hour, unable to sleep for days, and with little hope of recovery. Since last August, the European Medicines Agency (EMA) has approved the first and only therapy in the world for the treatment of Acanthamoeba infection that allows for reduced administration only during the day and for an average duration of about four months. An eye drop based on poliesanide, effective in 85% of cases, only if therapy is started within 30 days of the onset of symptoms, and whose timely access allows for avoiding corneal transplantation in the most serious cases. A therapeutic success resulting from Italian research, but paradoxically not yet available to patients in our country, which in the meantime, they are asking to be able to access them through the AIFA fund for orphan drugs", explains Vincenzo Sarnicola , President of the 23rd Congress of the International Society of Cornea, Stem Cells and Ocular Surface (SICCSO), currently underway in Grosseto, and one of the world's leading experts on the cornea.

The delay

“With the exception of a single center whose request was accepted, early access to the drug is proving inexplicably problematic. The excessively long times for authorization do not guarantee the right of patients to treatment that is effective only if administered promptly,” he points out. “Patients with Acanthamoeba keratitis, very often young, while waiting to access the only specific approved therapy, are facing unheard of suffering and risk serious permanent consequences, including the possibility of losing their sight or the entire eye. The appeal and hope are that AIFA will soon be able to respond to this need and remedy this situation, immediately making the therapy available to patients who have effectively put their lives on hold, as is permitted by the current AIFA regulations.”

Acanthamoeba keratitis

Acanthamoeba keratitis is a rare ophthalmic disease that affects approximately 3 million people worldwide every year, especially in the younger age group, 60% of whom are female. In Italy, it is estimated that 1 case of infection occurs approximately every three days. “It is an invisible pathogen that lives in water, and becomes active as a parasite when it finds a host from which to draw nourishment,” continues Sarnicola. “It penetrates and gnaws at the eyeball, “eating” the sight and effectively extinguishing any life project because the reduction in visual acuity is permanent.” Those most at risk, starting with the very young, are people who wear contact lenses when they bathe in swimming pools, the sea, lakes and rivers, but also when they are in the shower. The incidence of Acanthamoeba keratitis increases in the summer months because the heat encourages diving and attention to hygiene is relaxed. "Finally today, as demonstrated by clinical studies, the innovative therapy is effective and able, for the first time, to destroy the amoeba and eradicate the infection. A successful bet that gives patients back the hope of recovery, but which urgently needs to be made available to the sick to return to life", concludes Sarnicola.