Opthea Limited · ASX:OPT
Opthea — Angiogenesis, Exudation & Degeneration 2022
20 slides from Opthea's conference presentation, Feb 14, 2022
Slide 1: OPT-302 Combination Therapy in Polypoidal Choroidal Vasculopathy
OPT-302 Combination Therapy in Polypoidal Choroidal Vasculopathy Gemmy Cheung MBBS, FRCOphth, FAMS, MCI Head and Senior Consultant, Medical Retina Department, Singapore National Eye Center, Singapore Eye Research Institute, Singapore Angiogenesis, Exudation & Degeneration 2022, Virtual
Slide 2: Disclaimer
Disclaimer This presentation includes general background information about the activities of Opthea Limited (ABN 32 006 340 567) (‘Opthea’ or ‘Company’) and its affiliates and subsidiaries (together, the ‘Opthea Group’). The information contained in this presentation is in summary form and does not
Slide 3: Disclosures
Disclosures • Topcon • Zeiss • Heidelberg • Bayer • Novartis • Roche • Boehringer-Ingelheim • Allergan 3 Angiogenesis, Exudation & Degeneration 2022, Virtual
Slide 4: Key Take-Aways
Key Take-Aways • Opthea’s OPT-302 combination therapy has the potential to improve visual acuity outcomes over standard of care in patients with PCV • PCV is a subtype of wet AMD with variable response to current anti-VEGF therapy • OPT-302 combination with ranibizumab achieved superior visual acuit
Slide 5: OPT-302 Combination Therapy Enhances the Blockade of the Validated VEGF Pathways in wet AMD
OPT-302 Combination Therapy Enhances the Blockade of the Validated VEGF Pathways in wet AMD Used in combination with any VEGF-A inhibitor, OPT-302 completely blocks VEGFR-2 and VEGFR-3 signaling, inhibiting the most important pathways driving angiogenesis and vascular leakage VEGF-A inhibition eleva
Slide 6: OPT-302 Combination Therapy – Clinical Program
OPT-302 Combination Therapy – Clinical Program Now Recruiting Completed Completed Completed ShORe COAST Phase 1/2a Phase 1b/2a Phase 2b Phase 3 Phase 3 wet AMD DME Wet AMD wet AMD wet AMD (n=51) (n=153) (n=366) (n=990) (n=990) Comparator Comparator Comparator Comparator Comparator Ranibizumab Aflibe
Slide 7: Polypoidal Choroidal Vasculopathy: Role of VEGF-C/-D
Polypoidal Choroidal Vasculopathy: Role of VEGF-C/-D • PCV is a common subtype of nAMD • Distinct epidemiology, pathogenesis, natural history and treatment responses • PCV is more prevalent in the Asian population (up to 62%) than in the Caucasian population (8-13%) • Role of VEGF-C/VEGF-D in wet AM
Slide 8: Phase 2b Wet AMD Study Overview
Phase 2b Wet AMD Study Overview Treatment naïve patients Key Inclusion Criteria with neovascular AMD Key Exclusion Criteria • Active CNV >50% lesion, classic / • Subfoveal fibrosis or >25% of total lesion Screening minimally classic / occult • Haemorrhage >50% total lesion • BCVA ≥ 25 and ≤ 60 lette
Slide 9: Mean Change in Best Corrected Visual Acuity Baseline to Week 24
Mean Change in Best Corrected Visual Acuity Baseline to Week 24 20 OPT-302 (2.0 mg) Combination Therapy: Mean change in BCVA (SEM) 15 Superiority in Δ = +3.4 (p=0.0107) Visual Acuity over (letters) 10 Ranibizumab 5 Primary endpoint achieved 0 0 4 8 12 16 20 24 Weeks Sham + 0.5 mg ranibizumab 0.5 mg
Slide 10: Study Demographics and Baseline Characteristics
Study Demographics and Baseline Characteristics Demographic / Baseline Disease Characteristic Sham + 0.5 mg OPT-302 + 2.0 mg OPT-302 + ranibizumab ranibizumab ranibizumab N=121 N=122 N=123 Mean Age – years ± SD 76.1 ± 9.48 78.8 ± 8.16 77.8 ± 8.82 Sex – n (%) Male 48 (39.7%) 49 (40.2%) 45 (36.6%) Fem
Slide 11: Minimally Classic & Occult (>80% of study population)
Minimally Classic & Occult (>80% of study population) Best Responders: 20 Mean change in BCVA (SEM) Minimally 15 +16.1 Classic & Occult Δ = 5.7 *p = 0.0002 lesions (letters) 10 +10.3 Represents primary analysis 5 population in OPT-302 phase 3 program 0 0 4 8 12 16 20 24 Weeks Sham + 0.5 mg ranibizum
Slide 12: Pre-specified subgroup analysis of Phase 2b PCV
• In the Phase 2b clinical trial PCV was detected in 18% of patients Pre-specified • Independent Reading Center (DARC, NY) grading of possible PCV subgroup lesions at baseline • Evaluated by color FP, FA and SD-OCT analysis of • (note: ICGA was not used in the trial) Phase 2b PCV Sub-Group • Polyps
Slide 13: PCV Baseline Disease Characteristics
PCV Baseline Disease Characteristics Characteristic 0.5 mg ranibizumab + 0.5 mg ranibizumab + 0.5 mg ranibizumab + Sham 0.5 mg OPT-302 2.0 mg OPT-302 N=20 N=24 N=22 Vision Mean visual acuity (VA) – letters (±SD) 52.5 (±9.51) 54.8 (±5.45) 54.7 (±6.02) Anatomic Mean lesion area - mm2 (±SD) 6.71 (±3.66
Slide 14: Superior visual acuity following OPT-302 combination therapy in patients with PCV
Superior visual acuity at week 24 following OPT-302 combination therapy in patients with PCV 20 Δ = 6.7 *p = 0.0253 Mean change in BCVA (SEM) 15 13.5 (letters) 10 10.9 6.9 5 20 24 22 0 Sham + 0.5 mg ranibizumab 0.5 mg OPT-302 + 0.5 mg ranibizumab 2.0 mg OPT-302 + 0.5 mg ranibizumab (n=20) (n=24) (n=
Slide 15: Higher proportion of PCV patients gaining vision with OPT-302 combination therapy
Higher proportion of PCV patients receiving OPT-302 combination therapy in multiple categories of vision gain 100 100 100 80 90.9 80 80 80 60 77.3 59.1 % Participants % Participants % Participants % Participants 60 60 60 63.2 40 47.4 40 40 40 40.9 31.6 20 25.0 20 20 20 19 22 19 22 19 22 0 0 0 0 % Ga
Slide 16: Fewer PCV patients receiving OPT-302 combination therapy lost vision
Fewer PCV patients receiving OPT-302 combination therapy lost vision 20 20 20 15 15 15 15.8 % Participants % Participants % Participants 10 10.5 10 10.5 10 5 5 5 4.5 19 19 19 22 0 0 0 % Losing ≥ 15 Letters % Losing ≥ 10 Letters % Losing ≥ 5 Letters Sham + 0.5 mg ranibizumab 2.0 mg OPT-302 + 0.5 mg r
Slide 17: Greater anatomic improvements in PCV patients following OPT-302 combination therapy
Greater anatomic improvements in PCV patients following OPT-302 combination therapy Greater reductions in retinal fluid and lesion area % Participants with SRF % Participants with IR Cysts Mean Change in CST Mean Change in Total Lesion at Week 24 at Week 24 Baseline to Week 24 Area Baseline to Week
Slide 18: Key Take-Aways
Key Take-Aways • OPT-302 combination therapy has the potential to improve visual acuity outcomes over standard of care in patients with PCV • Following OPT-302 combination therapy in PCV patients: • Additional +6.7 letter gain (p=0.025)* over ranibizumab alone • Greater proportion of patients gained
Slide 19: OPT-302 Phase 3 Pivotal Program
Opthea intends to submit Biologics License and OPT-302 Phase 3 Pivotal Program Marketing Authorization Applications with the FDA and EMA, respectively, following Primary Efficacy Phase of the trials Efficacy Phase Safety Phase Ranibizumab (0.5 mg) + OPT-302 (2.0 mg) Ranibizumab (0.5 mg) + OPT-302 (2
Slide 20: Gemmy Cheung MBBS, FRCOphth, FAMS, MCI
Gemmy Cheung MBBS, FRCOphth, FAMS, MCI Head and Senior Consultant, Medical Retina Department, Singapore National Eye Center, Singapore Eye Research Institute, Singapore Angiogenesis, Exudation & Degeneration 2022, Virtual