Slide 1: ONS-5010 (bevacizumab-vikg) versus Ranibizumab for Neovascular AMD: NORSE-EIGHT Results
ONS-5010 (bevacizumab-vikg) versus Ranibizumab for Neovascular Age-related Macular Degeneration: Results from the NORSE-EIGHT Noninferiority Randomized Trial Baruch D Kuppermann, MD, PhD Steinert Endowed Professor Chair, Department of Ophthalmology Director, Gavin Herbert Eye Institute
Slide 2: ONS-5010 (bevacizumab-vikg)
ONS-5010 (bevacizumab-vikg) ONS-5010 is an ophthalmic intravitreal formulation of bevacizumab being developed to treat retinal diseases such as wet AMD, DME, and macular edema from BRVO1 ONS-5010 has the potential to become the first FDA-approved bevacizumab for ophthalmic use if approved and is man
Slide 3: ONS-5010 (bevacizumab-vikg) development
ONS-5010 (bevacizumab-vikg) development Completed Clinical Phase 3 Open-Label Experience Trial Safety and Efficacy Trial Safety Study 3-Month Non-Inferiority Study with 8-Week Efficacy Endpoint Per Special Protocol Assessment (SPA) Agreed with FDA
Slide 4: Safety and Effectiveness of ONS-5010 Compared to Ranibizumab in Neovascular AMD
Safety and Effectiveness of ONS-5010 Compared to Ranibizumab in Subjects with Neovascular Age-related Macular Degeneration ONS-5010 (1.25 mg) Monthly Intravitreal Injections Study design mirrors first three months of the Month 1 Month 2 Month 3 positive NORSE TWO Phase 3 study Primary Efficacy Endpo
Slide 5: Randomization
Randomization Subjects Screened n=602 Screen Failures n=202 Subjects ONS-5010 Ranibizumab Enrolled Parameters n=200 n=200 n=400 Reason for Early 6 (3.0%) 1 (0.5%) Discontinuation Subject withdrew 1 (0.5) 0 consent ONS-5010 Ranibizumab Adverse event 4 (2.0) 1 (0.5) n=200 n=200 Lost to follow-up 1 (0.
Slide 6: Demographic and Baseline Characteristics
Demographic and Baseline Characteristics ONS-5010 Ranibizumab Overall Characteristic Statistic (n=200) (n=200) (n=400) Female n (%) 133 ( 66.5) 115 ( 57.5) 248 ( 62.0) Age in years median (min, max) 79 (59, 96) 78 (56, 96) 79 (56, 96) Race White n (%) 194 ( 97.0) 195 ( 97.5) 389 ( 97.3) Black n (%)
Slide 7: Efficacy: Best Corrected Visual Acuity
Efficacy: Best Corrected Visual Acuity 14 ONS-5010 ranibizumab Mean Change (95%CI) in BCVA Letter Score 12 10 Difference between study arms 95%CI: 8 (-2.825, 0.413) Difference between P-value: 0.1444 6.5 6.3 study arms 95%CI: 6 4.4 5.5 (-2.865, -0.848) P-value: 0.2868 4 4.2 3.3 Difference between st
Slide 8: Efficacy: Central Foveal Thickness
Efficacy: Central Foveal Thickness 10 ONS-5010 ranibizumab Mean Change (±SE) in Central Foveal -10 -30 Thickness (µm) -50 -70 -90 -108.4 -110 -120.9 -106.6 -127.3 -130 -117.7 -123.9 -150 Baseline Day 30 Day 60 Day 90 SE: standard error.
Slide 9: Safety Results
Safety Results ONS-5010 Ranibizumab Adverse Events (n=200) (n=200) ≥ 1 Adverse Event n (%) 91 (45.5) 71 (36.0) ≥ 1 Ocular Adverse Event n (%) 51 (25.5) 47 (23.5) ≥ 1 Non-Ocular Adverse Event n (%) 58 (29.0) 35 (17.5) ≥ 1 Serious Adverse Event n (%) 9 (4.5) 5 (2.5) ≥ 1 Ocular Serious Adverse Event n
Slide 10: Safety Results: Frequency and Incidence of Ocular AEs
Safety Results: Frequency and Incidence of Ocular AEs ≥ 3 eyes ONS-5010 Ranibizumab Characteristic Statistic (n=200) (n=200) ≥ 1 Ocular TEAE in Study Eye n (%) 51 (25.5) 47 (23.5) Conjunctival hemorrhage n (%) 5 ( 2.5) 5 ( 2.5) Vitreous detachment n (%) 4 ( 2.0) 4 ( 2.0) Retinal pigment epithelial t
Slide 11: Safety Results: Frequency and Incidence of Non-ocular AEs
Safety Results: Frequency and Incidence of Non-ocular Characteristic AEs ≥ 2 patients Statistic ONS-5010 Ranibizumab (n=200) (n=200) ≥ 1 Arteriothrombitic Adverse Event* n (%) 1 (0.5) 1 (0.5) ≥ 1 Non-ocular Event n (%) 58 (29.0) 35 (17.5) Urinary tract infection n (%) 14 (7.0) 3 ( 1.5) Hypertension
Slide 12: Summary
Summary Clinically Relevant Outcomes • ONS-5010 demonstrated clinically meaningful anatomic and functional improvements across the NORSE EIGHT study • BCVA was statistically noninferior to ranibizumab at Day 30 and Day 90 • Change in central foveal thickness was similar in both study arms at all thr
Slide 13: Thank You
THERAPEUTICS Thank You 93