Aganirsen Medicine 13 December 2018 Extended indication Corneal neovascularisation (CoNV) - associated with keratoplasty rejection Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Aganirsen Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Corneal neovascularisation (CoNV) - associated with keratoplasty rejection Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Gene Signal Portfolio holder Mechanism of action Unknown Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Unknown Centre of expertise Additional remarks Insulin receptor substrate protein inhibitors. Antisense oligonucleotide. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options geen Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 1 druppel 0,86 mg/g References NCT02947867 Additional remarks Fase3: Studie uit 2014, daarna weinig. Er zou eigenlijk nog een fase 3 trial moeten komen of aganirsen een corneal graft rejection voorkomt, maar deze is niet terug te vinden. Expected patient volume per year Patient volume 30 - 40 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References SPS Additional remarks SPS: "In the United States, CoNV has been reported in 4.14% of patients presenting for general ophthalmic care. In 2014-15, there were 136 hospital admissions for CoNV in England, accounting for 27 bed days, and there were 3,169 corneal plastic operations." Uitgaande van 136 opnames in Engeland, zal het teruggerekend op basis van het aantal inwoners in Nederland gaan om ongeveer 30 - 40 opnames. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions Deen andere fase III studies op dit moment References clinicaltrials.gov, adisinsight Additional remarks Other information Additional remarks