Slide 1: Exhibit 99.1
Exhibit 99.1
Slide 2: NPDR Subset Analysis of ZETA-1 Phase 2 Trial
NPDR Subset Analysis of ZETA-1 Phase 2 Trial A moderate to severe NPDR-qualifying subgroup analysis to inform future clinical trials NPDR, non-proliferative diabetic retinopathy.
Slide 3: ZETA-1 Phase 2 Study Design and Baseline DRSS Scores
Primary endpoint: % of subjects with a ≥ 2 step improvement in monocular ETDRS DRSS at Week 24 Study eye: DR graded moderately severe to severe NPDR or mild PDR (monocular DRSS 47, 53, or 61) Fellow eye: No exclusion* Baseline DRSS Scores APX3330 (n=51) Placebo (n=52) DRSS Score – Study Eye 47 Moder
Slide 4: Baseline Differences Between ZETA-1 Actual and NPDR Subset
ZETA-1 Actual Compared to NPDR Subset Difference Between Baseline Characteristics for ZETA-1 Actual and NPDR Subset ZETA-1 Actual (n) NPDR Subset (n) Population with both eyes evaluable for DRSS1 971 59 Subjects with PDR 22 0 Subjects with DME 15 0 Subjects with PDR or DME2 35 0 Subjects with one ey
Slide 5: Binocular DRSS is a Validated Scale to Evaluate Systemic Therapies for Diabetic Retinopathy
NO DR NPDR PDR ETDRS monocular severity scale1 Binocular person-level scale1 Very mild Mild Moderate Moderately severe Severe or very severe Mild Patients graded by a central reading center based on fundus photography. DR, diabetic retinopathy; DRSS, Diabetic Retinopathy Severity Scale; ETDRS, Early
Slide 6: ≥3 Step Worsening on the Binocular DRSS Person-Level Scale
NPDR Subset Amplifies 3 Steps or Greater Worsening on the Binocular DRSS Person-Level Scale ZETA-1 Actual NPDR Subset ≥ 3 Step Worsening from Baseline on Binocular DRSS Person-Level Scale DRSS, Diabetic Retinopathy Severity Scale; NPDR, non-proliferative diabetic retinopathy. Source: ZETA-1 Table 14
Slide 7: ≥3 Step Improvement on the Binocular DRSS Person-Level Scale
NPDR Subset Amplifies 3 Steps or Greater Improvement on the Binocular DRSS Person-Level Scale ≥ 3 Step Improvement from Baseline on Binocular DRSS Person-Level Scale DRSS, Diabetic Retinopathy Severity Scale; NPDR, non-proliferative diabetic retinopathy. Source: ZETA-1 Table 14.2.2.7.3 and Table 14.
Slide 8: Enhanced Treatment Benefit on the Binocular DRSS Person-Level Scale
NPDR Subset Shows Enhanced Treatment Benefit on the Binocular DRSS Person-Level Scale ≥ 3 step improvement < 3 step change ≥ 3 step worsening Placebo ≥ 3 step improvement < 3 step change ≥ 3 step worsening APX3330 DRSS Change from Baseline DRSS, Diabetic Retinopathy Severity Scale; NPDR, non-prolife
Slide 9: ZETA-1 Actual: Fewer APX3330 Subjects Worsened and More Improved
ZETA-1 Actual: Fewer APX3330 Subjects Worsened and More Improved Compared to Placebo Subjects DRSS, Diabetic Retinopathy Severity Scale Source: ZETA-1 Table 14.2.3.7.1. 9 Worsening Improvement
Slide 10: Increased Treatment Benefit in Subjects with Steps or Greater Worsening
NPDR Subset Exhibits Increased Treatment Benefit in Subjects with 3 Steps or Greater Worsening DRSS, Diabetic Retinopathy Severity Scale. Source: ZETA-1 Table 14.2.3.7.3. 10 Worsening Improvement
Slide 11: Fewer APX3330 Subjects Developing PDR Compared to Placebo
NPDR Subset Demonstrates Enhanced Treatment Effect with Fewer APX3330 Subjects Developing PDR Compared to Placebo Development of PDR in Either Eye (DRSS ≥ 61 after Baseline) NPDR, non-proliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy. *One placebo subject did not have evalu
Slide 12: BCVA Comparable Between Treatment Groups at Week 24
BCVA Comparable Between Treatment Groups at Week 12 and Week 24 7+ letters worsening <7 letters change 7+ letters improvement Placebo 7+ letters worsening <7 letters change 7+ letters improvement APX3330 BCVA Change from Baseline BCVA, best-corrected visual acuity, study eye; NPDR, non-proliferative
Slide 13: Ocular AEs Similar Between APX3330 and Placebo
Ocular AEs similar between APX3330 and placebo Pruritis and rash were typically mild and self-limited Participants with DR continued routine medications to manage comorbid conditions AE, adverse event; DME, diabetic macular edema, DR, diabetic retinopathy. Source: ZETA-1 Tables 14.3.1.1, 14.3.1.7, 1
Slide 14: Potential Benefit of APX3330 in Patients with High Risk NPDR
NPDR Subset Demonstrates Potential Benefit of APX3330 in Patients with High Risk NPDR NPDR subset suggests treatment effect on 3 steps or greater worsening on the binocular DRSS person-level scale 3% of APX3330 subjects compared to 20% of placebo subjects had 3 steps or greater worsening at Week 24