The combination has been registered in nearly 60 countries for the prevention and treatment of inflammation and the prevention of infection associated with cataract surgery in adults. It is currently marketed in 50 countries worldwide.

Cataracts are a degenerative disease of the lens of the eye, the age limit for which is constantly decreasing. If not properly treated, cataracts can lead to discomfort, and visual impairment, and even blindness. Currently, cataract surgery is the only effective treatment and the most prevalent surgical procedure of all medical specialties with an estimated 20 million cases per year worldwide.

Despite updated guidelines, many ophthalmologists use protocols for postoperative management based primarily on their personal experience. In this context, providing new scientific evidence can give ophthalmologists new opportunities for choice.

The LEADER7 study, a multicentre, randomized, blinded-assessor, international phase 3 parallel group clinical trial involving more than 800 patients in over 50 centres, demonstrated that one-week course of the fixed combination of an ophthalmic quinolone antibiotic with an anti-inflammatory steroid is sufficient to resolve inflammation and prevent infection in patients undergoing cataract surgery.

The reduction in post-surgery treatment from 14 to 7 days on the one hand gives the opportunity to optimize the use of corticosteroids and hence reduce their side-effects, and on the other hand to reduce the exposure to antibiotics and, therefore, reduce the probability of the emergence of antibiotic resistance.

Finally, the shorter duration of treatment, along with the convenience of having both active ingredients in the same solution, represents an important element in improving adherence to therapy for patients undergoing cataract surgery, who are generally elderly.

In the next nine months, we expect approval and launch in almost ten additional new countries, and we are submitting applications for approval in a further 12 countries.

In 2025 we expect approval in 3 countries.