Regulatory Decision Summary for Eyezirgan
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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek market authorization for Eyezirgan (ganciclovir ophthalmic gel; 0.15%) in the treatment of superficial acute herpes simplex keratitis in adult patients.
Why was the decision issued?
This NDS is not considered to meet the requirements under subsection C.08.002 (2) of the Food and Drug Regulations. Therefore, a NOD is recommended for this submission based on the following major deficiencies:
- The lots used in the clinical studies have not been demonstrated to be representative of the proposed commercial product as required under subsection C.08.002 (2)(m) of the Food and Drug Regulations.
- The proposed Formulation C (containing sorbitol) is different from the Formulation B (containing mannitol) used in the clinical studies. The clinical impact on the eye of replacing mannitol by sorbitol cannot be predicted from the results of in vitro studies alone. Therefore, the replacement of mannitol by sorbitol is not sufficiently justified. The change in formulation could be significant and the impact of this change on safety and efficacy needs to be addressed.
Decision issued
Rejected; issued a Notice of Deficiency - Withdrawal Letter in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| EYEZIRGAN | 02530546 | LABORATOIRES THEA | GANCICLOVIR 0.15 % / W/W |