Table 2.

Number of Participants with Reported Safety Events by Treatment Group

Assessment	All Participants (n = 12)	GEM103 Dose Group
		50 μg (n = 3)	100 μg (n = 3)	250 μg (n = 3)	500 μg (n = 3)
Any TEAEs	4 (33.3)	2 (66.7)	0 (0)	2 (66.7)	0 (0)
DLTs	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
SAEs	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
GEM103-related AEs	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
GEM103-unrelated AEs	4 (33.3)	2 (66.7)	0 (0)	2 (66.7)	0 (0)
IVT injection-related AEs	2 (16.7)	1 (33.3)	0 (0)	1 (33.3)	0 (0)
Ocular inflammation	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Serum antibodies	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
TEAEs by system organ class preferred term
Eye disorders	4 (33.3)	2 (66.7)	0 (0)	2 (66.7)	0 (0)
Eye irritation	2 (16.7)	0 (0)	0 (0)	2 (66.7)	0 (0)
Eye pain	1 (8.3)	0 (0)	0 (0)	1 (33.3)	0 (0)
Macular fibrosis	1 (8.3)	0 (0)	0 (0)	1 (33.3)	0 (0)
Ocular hyperemia	1 (8.3)	1 (33.3)	0 (0)	0 (0)	0 (0)
Posterior capsule opacification	1 (8.3)	0 (0)	0 (0)	1 (33.3)	0 (0)
Retinal depigmentation	1 (8.3)	0 (0)	0 (0)	1 (33.3)	0 (0)
Retinal hemorrhage	1 (8.3)	1 (33.3)	0 (0)	0 (0)	0 (0)
Injury, poisoning, and procedural complications	1 (8.3)	0 (0)	0 (0)	1 (33.3)	0 (0)
Contusion	1 (8.3)	0 (0)	0 (0)	1 (33.3)	0 (0)
Fall	1 (8.3)	0 (0)	0 (0)	1 (33.3)	0 (0)

AE = adverse event; DLT = dose-limiting toxicity; IVT = intravitreal; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

Data are presented as no. (%) within each group. At each level of participant summarization, a participant is counted once if the participant reported 1 or more events. Treatment-emergent adverse events are shown for the total of 12 participants, 3 in each of the following dose groups: 50 μg, 100 μg, 250 μg, or 500 μg. Adverse events related to the study drug and AEs related to the IVT injection are included, as are TEAEs by system organ class and preferred term.