Regulatory Decision Summary for Netildex (with Preservative), Netildex (without Preservative)
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
This New Drug Submission (NDS) was originally filed on December 18, 2017 to obtain market authorization for Netildex, both with and without preservative. The proposed indication was treatment of inflammatory ocular conditions of the anterior segment of the eye, including post-operative cases, where bacterial infection or a risk of bacterial infection exists. Although the Clinical review division (DAID, Division of Anti-Infective Drugs) concluded their assessment with a recommendation for approval, this NDS received a Notice of Non-Compliance (NON) on December 4th, 2018 based on quality concerns raised by the New Drug Quality Division (NDQD). The Response to the NON (R-NON) was then filed in May 2019 and is the subject of this current submission.
Why was the decision issued?
Health Canada considers that the benefit-harm-uncertainty profile of Netildex is favorable for post-cataract surgery use in adult patients for the treatment of inflammatory conditions of the anterior segment of the eye and to reduce the risk of bacterial infection. This benefit was demonstrated in one phase 3 clinical trial, evaluating patients with mild to moderate inflammation, treated with Netildex (N = 135) or with active comparator (N = 73) for 7 days following cataract surgery and intraocular lens implantation. The Netildex fixed dose combination solution formulation has the potential to minimize patient non-compliance, especially for the predominantly older patient population.
The pooled clinical trial safety data showed that the most common adverse reactions in post-cataract surgery patients treated with Netildex or its individual components were symptoms of ocular discomfort (pain, photophobia, tearing, burning, stinging, itching, and blurred vision). Serious adverse reactions occurred in 0.5% (4/751) of patients (bacterial conjunctivitis, corneal oedema, endophthalmitis, uveitis). Safety concerns were adequately addressed in labelling.
A Risk Management Plan (RMP) was submitted and reviewed by the Marketed Health Products Directorate (MHPD).
Based on the safety and efficacy assessment of both the pre-clinical and clinical data submitted, the benefit-harm-uncertainty profile was considered favorable and supportive of Netildex as a useful addition to the available therapies for managing post-cataract surgery inflammation and risk of infection, as per the authorized indication and conditions of use, especially in the context of antimicrobial resistance.
Regarding the Quality assessment, in their response to the NON, the sponsor addressed all of the issues raised by NDQD. The final NDQD recommendation for an NOC was issued on September 26th, 2019 and Managers Memo uploaded October 17th, 2019 (NDQD NOC Memo). The final approved Product Monograph (PM) after Clinical, Quality, and Labelling Review is dated October 8th, 2019 (Approved PM).
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| NETILDEX | 02493195 | SIFI S.P.A. | DEXAMETHASONE (DEXAMETHASONE SODIUM PHOSPHATE) 0.1 % / W/V NETILMICIN (NETILMICIN SULFATE) 0.3 % / W/V |
| NETILDEX | 02493187 | SIFI S.P.A. | DEXAMETHASONE (DEXAMETHASONE SODIUM PHOSPHATE) 0.1 % / W/V NETILMICIN (NETILMICIN SULFATE) 0.3 % / W/V |