Sponsor response The TGA’s comment regarding the duration of treatment of Ilevro is The following statement has been included in the Precautions section of the PI: Post marketing experience with topical NSAIDs also suggest that use for more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events. In addition, the and Administration’ section of the draft PI has been revised to ‘Dosage reflect the change in duration of treatment. The following statement is proposed: For the prevention and treatment of pain and inflammation, the dose is 1 drop of Ilevro in the conjunctival sac of the affected eye(s) once a day beginning 1 day to cataract surgery, continued on the day of surgery and up to 14 days of the postoperative period, as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery. The revised PI is included (Proposed Australian PI and package insert.). The CMI will be revised in alignment with the approved PI. Evaluator’s comment The sponsor’s response is acceptable from an RMP perspective. Recommendation #3 in RMP evaluation report In the header of the EU-RMP, it is stated 8.0” however elsewhere the version is “Version listed as 6.1. The sponsor should confirm the correct version number. Sponsor response The discordance is due to the use of an electronic system for handling documents where every time a new version is made effective the version number in the header rolls out to the following number. The version of the RMP under evaluation is the version 06.1 (EU-RMP-NEVANAC-06.1) as described throughout the document. This version corresponds to the eighth electronic version (effective date: 20 September 2013). The applicant did not find the technical possibility to harmonise paper version and electronic versions. Evaluator’s comment The sponsor’s response is noted. Recommendation #4 in RMP evaluation report The sponsor notes that on account of the low systemic absorption of the drug and its active metabolite… both known and potential risks are limited to local effects. The sponsor should provide justification for this statement and for not considering systemic absorption as a potential risk. Sponsor response The sponsor has provided the requested justification (see Section 31 response). Evaluator’s comment The sponsor’s response is acceptable from an RMP perspective.
Sponsor response The TGA’s comment regarding the duration of treatment of Ilevro is The following statement has been included in the Precautions section of the PI: Post marketing experience with topical NSAIDs also suggest that use for more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events. In addition, the ‘Dosage and Administration’ section of the draft PI has been revised to reflect the change in duration of treatment. The following statement is proposed: For the prevention and treatment of pain and inflammation, the dose is 1 drop of Ilevro in the conjunctival sac of the affected eye(s) once a day beginning 1 day to cataract surgery, continued on the day of surgery and up to 14 days of the postoperative period, as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery. The revised PI is included (Proposed Australian PI and package insert.). The CMI will be revised in alignment with the approved PI. Evaluator’s comment The sponsor’s response is acceptable from an RMP perspective. Recommendation #3 in RMP evaluation report In the header of the EU-RMP, it is stated “Version 8.0” however elsewhere the version is listed as 6.1. The sponsor should confirm the correct version number. Sponsor response The discordance is due to the use of an electronic system for handling documents where every time a new version is made effective the version number in the header rolls out to the following number. The version of the RMP under evaluation is the version 06.1 (EU-RMP-NEVANAC-06.1) as described throughout the document. This version corresponds to the eighth electronic version (effective date: 20 September 2013). The applicant did not find the technical possibility to harmonise paper version and electronic versions. Evaluator’s comment The sponsor’s response is noted. Recommendation #4 in RMP evaluation report The sponsor notes that on account of the low systemic absorption of the drug and its active metabolite… both known and potential risks are limited to local effects. The sponsor should provide justification for this statement and for not considering systemic absorption as a potential risk. Sponsor response The sponsor has provided the requested justification (see Section 31 response). Evaluator’s comment The sponsor’s response is acceptable from an RMP perspective.
auspar-nepafenac-151223.docx