Table 2. Adverse events in the MAHALO phase 2 clinical trial.

All data are n (%). AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities.

Overall profile
Adverse eventSham pooled
(n = 42)
Lampalizumab monthly
(n = 43)
Lampalizumab EOM
(n = 44)
Patients with at least one event, n (%)
  Ocular SAEs in the study eye1 (2.4)03 (6.8)
  Ocular SAEs in the fellow eye1 (2.4)02 (4.5)
  Systemic (nonocular) SAEs15 (35.7)11 (25.6)10 (22.7)
  Ocular AE in the study eye suspected to be caused by study drug04 (9.3)3 (6.8)
  Nonocular AE suspected to be caused by study drug01 (2.3)1 (2.3)
Ocular adverse events in the study eye (occurring in ≥3 patients in any group; all treated patients)
MedDRA-preferred termSham pooled
(n = 42)
Lampalizumab monthly
(n = 43)
Lampalizumab EOM
(n = 44)
Any ocular AEs in the study eye, n (%)24 (57.1)36 (83.7)30 (68.2)
Ocular AEs in the study eye occurring in ≥3 patients in any group, n (%)
  AMD02 (4.7)3 (6.8)
  Blepharitis2 (4.8)1 (2.3)6 (13.6)
  Cataract3 (7.1)2 (4.7)3 (6.8)
  Conjunctival hemorrhage9 (21.4)21 (48.8)15 (34.1)
  Conjunctival edema01 (2.3)3 (6.8)
  Dry eye02 (4.7)3 (6.8)
  Eye irritation1 (2.4)4 (9.3)4 (9.1)
  Eye pain4 (9.5)10 (23.3)6 (13.6)
  Eye pruritus3 (7.1)1 (2.3)3 (6.8)
  Foreign body sensation in eyes1 (2.4)4 (9.3)2 (4.5)
  Intraocular pressure increased06 (14.0)7 (15.9)
  Lacrimation increased1 (2.4)3 (7.0)4 (9.1)
  Ocular hyperemia2 (4.8)3 (7.0)5 (11.4)
  Punctate keratitis1 (2.4)4 (9.3)2 (4.5)
  Retinal hemorrhage3 (7.1)1 (2.3)3 (6.8)
  Vision blurred1 (2.4)2 (4.7)3 (6.8)
  Vitreous detachment3 (7.1)2 (4.7)4 (9.1)
  Vitreous floaters1 (2.4)3 (7.0)2 (4.5)