Regulatory Decision Summary for Eylea HD (aflibercept)

This Supplement to a New Drug Submission (SNDS) seeks to update the Product Monograph of Eylea HD based on 96-week pivotal study data for wet age-related macular degeneration (AMD) and diabetic macular edema (DME), including revisions to Dosage and Administration, Warnings and Precautions, Adverse Reactions, and Clinical Trials section. It also proposes extending the dosing interval from up to 16 weeks to up to 20 weeks.

Clinical efficacy and safety of Eylea HD were assessed in two randomized, multi-center, double-masked, active-controlled studies which included 870 patients with wet age-related macular degeneration (AMD) in the Study PULSAR, and 660 patients with diabetic macular edema (DME) in the Study PHOTON. The findings from the Week 96 data from the PULSAR and PHOTON studies, confirmed that efficacy assessed by the change from baseline in best corrected visual acuity (BCVA) is maintained when extending the treatment interval to 12–16 weeks. Additionally, a substantial proportion of patients extended to 20-week dosing, and the efficacy was maintained. These findings highlight HD aflibercept’s potential to reduce treatment burden while ensuring durable visual and anatomical outcomes.

The most frequently reported adverse events in patients treated with Eylea HD in Study PULSAR (wet AMD) observed up to Week 96 were cataract, visual acuity reduced, retinal haemorrhage, subretinal fluid and vitreous floaters. The most frequently reported adverse events in patients treated with Eylea HD in Study PHOTON (DME) observed up to Week 96 were cataract, vitreous floaters, conjunctival hemorrhage, and vitreous detachment. This is consistent with the known safety profile of Eylea HD and the risks are considered adequately mitigated through the information provided in the Product Monograph. Overall, the safety profile of Eylea HD up to Week 96 used for the treatment of wet AMD and DME in adults appears comparable to the established profile of the original formulation (i.e. Eylea 2 mg administered every 8 weeks).

Based on the totality of evidence provided in this submission, there is no change observed in the benefit-risk profile of Eylea HD, which is thus considered favourable when used for the treatment of wet AMD and DME in adults.

For further details about Eylea HD, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.