Table 2. Most frequently reported treatment-emergent ocular adverse events in two randomised, double-blind placebo-controlled studies comparing intravitreal ocriplasmin with placebo (adapted from Stalmans et al158).
| Adverse event | Placebo (n=187) No. of events (%) | Ocriplasmin (n=465) No. of events (%) | P-valuea |
|---|---|---|---|
| Any ocular adverse event | |||
| Vitreous floatersb | 14 (7.5) | 78 (16.8) | 0.002 |
| Photopsiab | 5 (2.7) | 55 (11.8) | <0.001 |
| Conjunctival haemorrhage | 24 (12.8) | 68 (14.6) | 0.53 |
| Injection-related eye painb | 11 (5.9) | 63 (13.5) | 0.005 |
| Blurred visionb | 6 (3.2) | 40 (8.6) | 0.01 |
| Visual impairmentb | 3 (1.6) | 25 (5.4) | 0.02 |
| Increased intraocular pressure | 10 (5.3) | 18 (3.9) | 0.50 |
| Retinal tear | 5 (2.7) | 6 (1.3) | 0.25 |
| Cataract | 17 (9.1) | 26 (5.6) | 0.13 |
| Any ocular serious adverse eventsc | |||
| Macular hole | 16 (8.6) | 24 (5.2) | 0.15 |
| Retinal detachment | 3 (1.6) | 2 (0.4) | 0.16 |
| Reduced visual acuity | 1 (0.5) | 3 (0.6) | 0.94 |
a
Calculated by the Cochran–Mantel–Haenszel test, stratified according to study.
b
Based on subjective reports by study participants.
c
Identified as such by the investigator and defined as one of the following: an event resulting in persistent or clinically significant disability, incapacity, or both; an event requiring in-patient hospitalisation or prolongation of an existing hospital stay; or an event that was considered to be medically important.