Abstract
Purpose :
To better understand the timing of IOP >25 mmHg in the PALADIN Study
Methods :
The PALADIN study is a 3-year observational US based prospective trial designed to explore safety signals with FAc when used in a real-world observational setting. A subset of patients’ eyes with IOP > 25 mmHg were further analyzed from the PALADIN 24-month completer readout.
Results :
Among 115 eyes reported, 37 events of an IOP >25 mmHg were reported. Among this group, there were 9 reported events of IOP > 30 mmHg. The majority of the eyes who experienced an IOP >25mmHg had received additional DME therapies during the follow-up period; they also had a baseline IOP > 15mmHg (76.9%). A small number of eyes with IOP > 25 mmHg were reported at all visits through month 24 with more occurring in year 1 vs year 2. 27% of events of IOP>25 mmHg occurred by 3 months. 49% occurred by 6 months, 62% by 9 months, and 72% occurred by month 12. Through 24 months, there were 9 events of IOP >30mmHg. Of the 9 events of IOP >30mm Hg, 78% were reported within the first 12 months of treatment, with the earliest being reported at month 2.
Conclusions :
: A rise in IOP above 25mmHg is reported in a minority of eyes. 70% of eyes who experienced this event had it in year 1. Patients should have their IOP monitored at regular intervals to ensure timely detection of any IOP rise.
Thi
This is a 2021 ARVO Annual Meeting abstract.