TEAEs, over 48 weeks
| CLS-TA (N=28) | Control (N=5) | Total (N=33) | |
| n (%) of n subjects events | n (%) of n subjects events | n (%) of n subjects events | |
| Any TEAE | 19 (67.9) 60 | 3 (60.0) 8 | 22 (66.7) 68 |
| Any TEAE in the Study eye | 18 (64.3) 30 | 3 (60.0) 5 | 21 (63.6) 35 |
| Any non-ocular TEAE | 4 (14.3) 18 | 1 (20.0) 2 | 5 (15.2) 20 |
| Any SAE | 1 (3.6) 10 | 0 | 1 (3.0) 10 |
| Any SAE in the Study eye | 0 | 0 | 0 |
| Any non-ocular SAE | 1 (3.6) 10 | 0 | 1 (3.0%) 10 |
| Deaths | 0 | 0 | 0 |
| Any on-study TEAE | 16 (57.1) 37 | 3 (60.0) 6 | 19 (57.6) 43 |
| Any on-study TEAE in the Study eye | 16 (57.1) 20 | 3 (60.0) 4 | 19 (57.6) 24 |
| Any on-study non-ocular TEAE | 2 (7.1) 11 | 1 (20.0) 2 | 3 (9.1) 13 |
|
n (%) of
Subjects |
n (%) of
Subjects |
n (%) of
Subjects | |
| Any IOP-related event | 4 (14.3) | 0 | 4 (12.1) |
| IOP increase ≥10 mm Hg | 4 (14.3) | 0 | 4 (12.1) |
| IOP ≥25 mm Hg | 2 (7.1) | 0 | 2 (6.1) |
| IOP ≥30 mm Hg | 1 (3.6) | 0 | 1 (3.0) |
| IOP ≥35 mm Hg | 0 | 0 | 0 |
| Use of IOP-lowering medication at crossover visit* | 2 (7.1) | 0 | 2 (6.1) |
| Use of any additional IOP-lowering medication† | 1 (3.6) | 0 | 1 (3.0) |
| Surgery for elevated IOP | 0 | 0 | 0 |
| Any cataract | 7 (25.0) | 1 (20.0) | 8 (24.2) |
| Surgery for cataract | 2 (7.1) | 0 | 2 (6.1) |
*Includes those medications that started during PEACHTREE and continued into MAGNOLIA.
†Includes those medications that started during MAGNOLIA.
IOP, intraocular pressure; SAE, serious adverse event; TEAEs, treatment-emergent adverse events.