Regulatory Decision Summary for IZBA

Health Canada considers that the anticipated benefits of Izba outweigh its potential risks.

The pivotal study supporting this submission was a multicenter, double-masked, randomized, active-controlled, 2-arm, parallel-group, equivalence study designed to evaluate the safety and efficacy of Izba relative to Travatan (travoprost 0.004% solution) in adult patients with open-angle glaucoma or ocular hypertension. A total of 864 patients were randomized, with 442 randomized to the Izba group and 422 randomized to the Travatan group. The primary efficacy endpoint of the study was mean IOP evaluated at three on-therapy study visits at Week 2, Week 6, and Month 3 and assessment time points at 8 AM, 10 AM, and 4 PM.

The change in IOP from baseline, the percent change in IOP from baseline, the percentage of patients who achieved a target IOP level of <18 millimeters of mercury (mmHg), and the percentage of patients who achieved IOP-lowering of at least 30% from baseline were included as supportive efficacy endpoints.

In the primary efficacy analysis, in order to conclude equivalence, the 2-sided 95% confidence interval for the difference in IOP between treatment groups must have been within ±1.5 mmHg at each of the 3 assessment time points for each on-therapy visit. In addition, the two-sided 95% confidence intervals for the difference in mean IOP were to be within ±1.0 mmHg at the majority of time points.

Results from this study showed that the IOP-lowering efficacy of Izba was equivalent to Travatan as the 2-sided 95% confidence interval for the difference in IOP between treatment groups was within ±1.5 mmHg at each of the three assessment time points for each on-therapy visit. In addition, the two-sided 95% confidence intervals for the difference in mean IOP were all within ±1.0 mmHg at all visits and time points.

Supportive efficacy results supported the equivalence observed during primary efficacy analysis.

In terms of safety, the majority of adverse events (AE) reported for either treatment group during the study were related to local ocular effects with a known casual association with the use of travoprost and topical ocular prostaglandin analogs in general. The most common adverse drug reaction reported in the study was hyperemia of the eye (11.8% vs. 14.5% for Izba and Travatan respectively, ocular and conjunctival hyperemia combined). No serious AE in the study was assessed as related to the use of Izba.

In conclusion, the IOP-lowering efficacy of Izba was shown to be equivalent to the efficacy of Travatan, with an acceptable safety profile. The benefits of Izba are considered to outweigh the potential risks under the conditions of use described in the Product Monograph.