Table 3 Ocular treatment-emergent adverse events (TEAEs) by investigator assessment of relationship to study medication

(study eye only, safety population)   Besifloxacin 0.6 % (N = 344) Vehicle (N = 170) Unlikely or unrelated Relateda Unlikely or unrelated Relateda Total number of TEAEs 14 5 6 6 Number of subjects with at least 1 TEAE 13 (3.8 %) 4 (1.2 %) 6 (3.5 %) 5 (2.9 %) Conjunctivitis 3 (0.9 %) 0 1 (0.6 %) 2 (1.2 %) Eyelid erythema 2 (0.6 %) 0 0 0 Blepharitis 1 (0.3 %) 0 1 (0.6 %) 0 Corneal infiltrates 1 (0.3 %) 0 0 0 Dacryocystitis 1 (0.3 %) 0 0 0 Eye pain 1 (0.3 %) 0 Wnt assay 0 0 Lacrimation increased 1 (0.3 %) 0 0 0 Conjunctival hemorrhage 1 (0.3 %) 0 0 0 Conjunctival edema 1 (0.3 %) 0 0 1 (0.6 %) Conjunctivitis, allergic 0 0 1 (0.6 %) 0 Punctate keratitis 0 1 (0.3 %) 0 1 (0.6 %) Scleritis 0 0 1 (0.6 %) 0 Instillation site pain/irritation/erythema 0 2 (0.6 %) 0 1 (0.6 %) Instillation site reaction 0 2 (0.6 %) 0 1 (0.6 %) Pain 0 0 1 (0.6 %) 0 Herpes dermatitis 1 (0.3 %) 0 0 0 Post-traumatic pain 0 0 AP24534 clinical trial 1 (0.6 %) 0 Corneal staining 1 (0.3 %) 0 0 0 aIncludes events considered by investigator as “possibly”, “probably”, or “definitely” related; events with unknown relationship were counted as “probably related” Ocular TEAE reported in fellow treated eyes were similar to those reported in study eyes with 21 events reported in 18/220 (8.2 %) besifloxacin treated

Acetophenone patients and 11 events reported in 11/115 (9.6 %) vehicle treated patients (p = 0.6855). Consistent with study eyes, one case of instillation site reaction in each treatment group was considered “definitely related” to study

treatment. Further, three ocular TEAEs (punctate keratitis, instillation site erythema, and instillation site reaction) in the besifloxacin group and two TEAEs (conjunctivitis and instillation site irritation) in the vehicle group were considered “possibly related” to treatment. All ocular TEAEs in the fellow treated eyes were considered mild or moderate in severity. 3.5 Nonocular Treatment-Emergent Adverse Events (TEAEs) Overall, 16 nonocular TEAEs were reported by 15 subjects (Table 4), including 10 events in 9/344 (2.6 %) besifloxacin subjects and six events in 6/170 (3.5 %) vehicle subjects; there was no significant difference in the incidence of nonocular TEAEs between the two treatment groups (p = 0.5837). One nonocular event (mild dysgeusia in the besifloxacin group) was considered definitely related to treatment; this event resolved without treatment, and the subject was not discontinued from the study. All other nonocular events were considered unrelated or unlikely related to study treatment. No serious AEs were reported or observed. Table 4 Nonocular treatment-emergent adverse events (TEAEs) by investigator assessment of relationship to study medication (safety population)   Besifloxacin 0.