potential risk of ‘Systemic corticosteroid effect’ (infection, hypertension and impaired healing) has already been included in the EU RMP v 7.0. Allergan believes that current EU RMP v 7.0 (along with the ASA v2.0) adequately addresses any safety concern(s) arising out of use of Ozurdex in Australia. It is recommended that the The sponsor agrees It is agreed that important potential risk: that post approval of routine ‘Off use’ be included as a new Ozurdex in Australia ongoing safety concern given for the proposed and risk the sponsor is not seeking to indication there is a minimisation register the EU approved potential for off label are appropriate indications (that is the use for the remaining for this new treatment of adult patients approved indications ongoing safety with macular oedema in the EU and the US concern specific following either Branch (macular oedema to Australia. Retinal Vein Occlusion (BRVO) following BRVO or Nevertheless to or Central Retinal Vein CRVO and ensure that it is Occlusion (CRVO) and for the uveitis). appropriately treatment of adult patients However, the sponsor monitored by with inflammation of the argues that safety routine posterior segment of the eye concerns (if any) presenting as non-infectious associated with the it is reiterated uveitis). Consideration must use of Ozurdex in that label ‘Off be given as to what adult patients with use’ should be pharmacovigilance and risk macular oedema included as an minimisation activities will be following BRVO or important proposed for this new ongoing CRVO and potential risk, safety concern and only the posterior which need only ASA need be revised uveitis will be similar, be reflected in a accordingly. if not, less than those revised ASA expected with its preferably usage in diabetic before this macular oedema application is patients. On this basis approved. the sponsor refuses to amend Section 2 of the ASA as recommended. The EU RMP states the The sponsor states: This is following for Version 3.0 dated in EU RMP acceptable. “While May 2013: v4.0, Allergan “Systemic
potential risk of ‘Systemic corticosteroid effect’ (infection, hypertension and impaired healing) has already been included in the EU RMP v 7.0. Allergan believes that current EU RMP v 7.0 (along with the ASA v2.0) adequately addresses any safety concern(s) arising out of use of Ozurdex in Australia. It is recommended that the important potential risk: ‘Off use’ be included as a new ongoing safety concern given the sponsor is not seeking to register the EU approved indications (that is the treatment of adult patients with macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO) and for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as non-infectious uveitis). Consideration must be given as to what pharmacovigilance and risk minimisation activities will be proposed for this new ongoing safety concern and only the ASA need be revised accordingly. The sponsor agrees that post approval of Ozurdex in Australia for the proposed indication there is a potential for off label use for the remaining approved indications in the EU and the US (macular oedema following BRVO or CRVO and uveitis). However, the sponsor argues that safety concerns (if any) associated with the use of Ozurdex in adult patients with macular oedema following BRVO or CRVO and posterior uveitis will be similar, if not, less than those expected with its usage in diabetic macular oedema patients. On this basis the sponsor refuses to amend Section 2 of the ASA as recommended. It is agreed that routine and risk minimisation are appropriate for this new ongoing safety concern specific to Australia. Nevertheless to ensure that it is appropriately monitored by routine it is reiterated that ‘Off label use’ should be included as an important potential risk, which need only be reflected in a revised ASA preferably before this application is approved. The EU RMP states the following for Version 3.0 dated May 2013: “Systemic The sponsor states: “While in EU RMP v4.0, Allergan This is acceptable.
auspar-dexamethasone-161025.docx