Common adverse event
The safety review showed that conjunctival hyperemia was the most common adverse event in all 3 study groups, but it occurred more often in patients using FDC netarsudil/latanoprost than in the netarsudil and latanoprost groups (63.0% versus 51.4% and 21.9%).
“In most patients who developed conjunctival hyperemia, it was graded as mild and occurred intermittently,” said Dr. Brubaker. “Its severity did not increase with ongoing treatment. By month 12, conjunctival hyperemia caused 7.6% of patients randomized to FDC netarsudil/latanoprost and 8.2% of those randomized to netarsudil to discontinue their treatment,”
Instillation site pain was the second most common adverse event in the FDC netarsudil/latanoprost and netarsudil groups (23.1% and 24.7% vs. 7.6% for latanoprost) followed by cornea verticillata (17.6% and 13.6% vs. 0%) and conjunctival hemorrhage (13.0% and 18.1% vs. 1.3%). Cornea verticillata was the cause of treatment discontinuation for 1.7% of netarsudil/latanoprost patients and 1.2% of netarsudil patients.