Maggio 2011 - Volume XXX - numero 5
Farmacoriflessioni
Laboratorio per la Salute Materno-Infantile, Dipartimento di Salute Pubblica, Istituto di Ricerche Farmacologiche “Mario Negri”, Milano
Indirizzo per corrispondenza: filomena.fortinguerra@marionegri.it
Key words: Topical ocular drugs, Eye diseases, Drug therapy, Paediatrics
Aim: A study was planned to analyse the availability and the licensing status of ocular drugs
marketed in Italy and evaluate the evidence on their safety and efficacy in paediatric population.
Materials and methods: A quantitative analysis was performed in order to evaluate the
number of ocular drugs with a paediatric licence in Italy. A literature search was also
performed in MEDLINE and EMBASE for randomized controlled trials (RCTs) concerning
ophthalmic pharmacological therapy in children aged < 18 years, published up to October
2010. A search in the international clinical trial registries and in the list of paediatric
investigation plans (PIPs) approved by EMA was performed in order to find which ocular
drugs are under paediatric investigation.
Results: In all, of 195 ocular drugs identified, 130 (67%) of which were marketed in
Italy, 62 (48%) with a paediatric licence. No published RCTs were found for one third of
ocular drugs licensed for paediatric use in Italy, while 21% of all retrieved studies were related
to 23 drugs not licensed for paediatric use. 59 (46%) of 128 retrieved RCTs regarded
mydriatic/cycloplegic medications. 62 RCTs (56% completed) on 46 drugs, were
found in the international clinical trial registries, while only 3 PIPs were approved by
EMA. Cyclosporine and bevacizumab were the drugs involved in many ongoing studies.
Conclusions:There is a need for further research and clinical development in the paediatric
ophthalmic area, where the availability of effective and up-to-date treatments investigated in
children remains a priority.
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