Phase 1b APEX study: multiple dose study of KSI-101 in patients with MESI End of Study Subjects with MESI (n=41) Weeks 0 4 8 12 16 20 24 2.5 mg 5 mg 10 mg 7 KSI-101 intravitreal injection Key inclusion criteria • Macular edema secondary to inflammation (MESI) • Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic. • Active leakage as evidenced by fluorescein angiogram. • OCT CST of ≥320 microns • BCVA score ≤75 and ≥25 (20/32 to 20/320 Snellen equivalent) Enrollment complete KSI-101 2.5 mg (n=13) KSI-101 5 mg (n=14) KSI-101 10 mg (n=14) All KSI-101 (N=41) Age, years, mean (SD) 74.2 (11.6) 67.4 (8.1) 67.5 (18.8) 69.6 (13.7) Female, n (%) 8 (61.5) 7 (50.0) 8 (57.1) 23 (56.1) Race, White, n (%) 11 (84.6) 11 (78.6) 14 (100) 36 (87.8) MESI disease duration, months , mean (SD) 12.2 (20.1) 1.7 (1.2) 15.8 (37.2) 11.1 (26.5) Inflammation anatomical location, n (%) Anterior 0 2 (14.3) 0 2 (4.9) Intermediate 1 (7.7) 0 2 (14.3) 3 (7.3) Posterior 10 (76.9) 6 (42.9) 10 (71.4) 26 (63.4) Panuveitis 2 (15.4) 6 (42.9) 2 (14.3) 10 (24.4) Patients with active inflammation, n (%) 3 (23.1) 10 (71.4) 5 (35.7) 18 (43.9) Unilateral MESI, n (%) 9 (69.2) 6 (42.9) 5 (35.7) 20 (48.8) BCVA, ETDRS Letters , mean (SD) 62.7 (7.4) 65.5 (7.8) 62.1 (8.4) 63.5 (7.8) Snellen equivalent ~20/50 ~20/50 ~20/63 ~20/50 OCT CST, μm , mean (SD) 461.7 (137.7) 487.0 (124.1) 528.6 (157.3) 493.2 (139.7) Lens Status, pseudophakic, n (%) 9 (69.2) 13 (92.9) 11 (78.6) 33 (80.5) Baseline Characteristics Study Design: Ongoing, Open-label Phase 1b in MESI The APEX study is ongoing. Final results may be different due to data cleaning.
The Retina Society 58th Annual Scientific Meeting Page 7 Page 9