Laboratorio per la Salute Materno-Infantile, Dipartimento di Salute Pubblica, Istituto di Ricerche Farmacologiche “Mario Negri”, Milano
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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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