Safety and tolerability (ITT population)
ADVERSE EVENT, DEEP VEIN THROMBOSIS, LUNG ADENOCARCINOMA, DRY EYE, CHRONIC LYMPHOCYTIC LEUKEMIA, ADVERSE EVENT, INTRAOCULAR PRESSURE
In the overall ITT/safety population (mild, moderate, and severe dry eye), more patients experienced more AEs and more treatment-emergent AEs (TEAEs) in the placebo group than in the PL9643 group (AEs: 22 [27.5%] vs. 16 [20.0%]; TEAEs: 20 [25.0%] vs. 13 [16.3%]) (Adverse Events by Severity and Relation to Treatment (Intent-to-Treat/Safety Population)Treatment-related TEAEs are those categorized as definite, probably, and possibly related.AE, adverse event; SAE, serious adverse event; TEAE, treatment-emergent adverse event.A total of 3 (1.9%) patients reported 3 treatment-emergent serious AEs: 1 (1.3%) patient in the PL9643 group and 2 (2.5%) patients in the placebo group. The 2 serious AEs in the placebo group were classified as severe (chronic lymphocytic leukemia, deep vein thrombosis), and the serious AE in the single patient in the PL9643 group was reported as moderate (lung adenocarcinoma). No treatment-emergent serious AEs were considered related to the study drug. No clinically significant effects on visual acuity, slit-lamp biomicroscopy, intraocular pressure, or dilated fundoscopy by PL9643 were observed.