Table 2

Safety outcomes at month 12

AE, n (%)Patients
(n=586)
Any AE118 (20.1)
Any TEAE118 (20.1)
Any treatment-related TEAE11 (1.9)
Any ocular TEAE (study eye)8 (1.2)
Most common ocular AE (>0.5%)
 Vitreous floaters11 (1.9)
 Lacrimation increased6 (1.0)
 Eye pain5 (0.9)
 Photophobia4 (0.7)
 Dry eye4 (0.7)
 Conjunctivitis4 (0.7)
 Eye irritation3 (0.5)
 Conjunctival haemorrhage3 (0.5)
 Eye pruritus3 (0.5)
 Vision blurred3 (0.5)
 Visual impairment3 (0.5)
Endophthalmitis0 (0.0)
Any SAE (>0.3%)23 (3.9)
 Cancer3 (0.5)
 Confusional state/disorientation3 (0.5)
 Ischaemic stroke3 (0.5)
Any nonocular TEAE
Most common nonocular AE (>0.5%)
 Product use issue17 (2.9)
 Cardiac failure5 (0.9)
 Bronchitis5 (0.9)
 Drug hypersensitivity5 (0.9)
 Injection site pain4 (0.7)
 Malaise4 (0.7)
 Falls4 (0.7)
 Gastroenteritis3 (0.5)
 Pneumonia3 (0.5)
 Vertigo3 (0.5)
 Back pain3 (0.5)
 Osteoarthritis3 (0.5)
 Ischaemic stroke3 (0.5)
 Syncope3 (0.5)
Death (not treatment related)
 Sudden3 (0.5)
 Secondary to AE6 (1.0)
 Any TEAE leading to discontinuation6 (1.0)
 Transient ischaemic attack1 (0.2)
Any treatment-related TEAE leading to discontinuation0
  • AE, adverse event; SAE, serious AE; TEAE, treatment-emergent AE.