Table 3.

Safety outcomes at Month 24

Safety population (N = 588)	Total n (%)
Any TEAE	226 (38.4)
Any treatment-related TEAE	59 (10.0)
Ocular	54 (9.2)
Non-ocular	5 (0.9)
Any ocular TEAE	136 (23.1)
Most common ocular AE
Lack of efficacy	37 (6.3)
Vitreous floaters	16 (2.7)
Lacrimation increased	10 (1.7)
Visual acuity reduced	9 (1.5)
Retinal pigment epithelium detachment	9 (1.5)
Any non-ocular TEAE	123 (20.9)
Most common non-ocular AE
Inappropriate schedule of drug administration	18 (3.1)
Bronchitis	11 (1.9)
Fall	7 (1.2)
Malaise	6 (1.0)
Influenza	5 (0.9)
Discontinuation due to TEAE	72 (12.2)
Discontinuation due to treatment-related TEAE	40 (6.8)
Any serious TEAE	64 (10.9)
Ocular	9 (1.5)
Non-ocular	59 (10.0)
Serious TEAE (> 0.5%)
Transient ischemic attack	4 (0.7)
Death	5 (0.9)

AE adverse events; TEAE treatment-emergent adverse event