Table 1.
TEAEs occurring ≥2% in the study eye during treatment with ACP 2 mg over 12 months in GATHER1 and GATHER2.
| GATHER1 12 monthsa | GATHER2 12 months | |||
|---|---|---|---|---|
| Ocular TEAEs, n (%) | ACP 2 mg (N = 67) | Sham (N = 110) | ACP 2 mg (N = 225) | Sham (N = 222) |
| Conjunctival hemorrhage | 10 (14.9) | 13 (11.8) | 27 (12.0) | 17 (7.7) |
| Punctate keratitis | 4 (6.0) | 8 (7.3) | 11 (4.9) | 14 (6.3) |
| Conjunctival hyperemia | 3 (4.5) | 4 (3.6) | 12 (5.3) | 13 (5.9) |
| Choroidal neovascularization | 6 (9.0) | 3 (2.7) | 15 (6.7) | 9 (4.1) |
| Dry eye | 0 | 2 (1.8) | 8 (3.6) | 8 (3.6) |
| Eye pain | 2 3.0) | 3 (2.7) | 9 (4.0) | 6 (2.7) |
| Vitreous detachment | 2 (3.0) | 5 (4.5) | 7 (3.1) | 6 (2.7) |
| Visual acuity reduced | 2 (3.0) | 4 (3.6) | 3 (1.3) | 5 (2.3) |
| Vision blurred | 1 (1.5) | 2 (1.8) | 6 (2.7) | 2 (0.9) |
| Visual impairment | 0 | 0 | 6 (2.7) | 2 (0.9) |
| Intraocular pressure increased | 4 (6.0) | 1 (0.9) | 21 (9.3) | 2 (0.9) |
| Vitreous floaters | 1 (1.5) | 1 (0.9) | 6 (2.7) | 1 (0.5) |
| Visual acuity reduced transiently | — | — | 6 (2.7) | 1 (0.5) |
| Blepharitis | 0 | 1 (0.9) | 6 (2.7) | 0 |
| Ocular hypertension | — | — | 5 (2.2) | 0 |
a
Both ACP 2 mg and sham groups are a combination of Part 1 and Part 2.
Notes: n = study eyes with events. A patient with multiple occurrences of an AE under one treatment is counted only once; — indicates data not collected.
ACP: Avacincaptad pegol; CNV: Choroidal neovascularization; TEAE: Treatment-emergent adverse event.
1. Jaffe GJ, et al. Ophthalmology. 2021;128(4):576–586; 2. Data on file. IVERIC bio; 3. Heier JS, et al. Presented at: AAO; September 30–October 3, 2022; Chicago, IL.