Slide 1: LUGANO Phase 3 Clinical Trial DURAVYU in Wet AMD Expanded Results & Analyses
LUGANO Phase 3 Clinical Trial DURAVYU in Wet AMD Expanded Results & Analyses | September 2026 Exhibit 99.1
Slide 2: Legal Disclaimers
Legal Disclaimers Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, even
Slide 3: Introduction
@ EvePoint Introduction _
Slide 4: A Leader in Sustained Release Drug Delivery for Retinal Disease
A Leader in Sustained Release Drug Delivery for Retinal Disease 1: Anti-VEGF sales, 2024 public financial statements AMD, age-related macular degeneration; DME, diabetic macular edema; TAM, total addressable market Multiple potential catalysts over next 16 months: LUCIA Phase 3 data expected Q4 2026
Slide 5: The DURAVYU Advantage: A Differentiated Program in Retina
The DURAVYU™ Advantage: A Differentiated Program in Retina 1. Data from preclinical studies. Following a single DURAVYU 900 µg dose in Dutch-Belted rabbits, vorolanib reached concentrations exceeding IC50 in the choroid and retina within hours of administration. 1. Wykoff CC, et al. J Vitreoretin Di
Slide 6: Robust Evidence For DURAVYU with Established Regulatory Path
Robust Evidence For DURAVYU with Established Regulatory Path Follows non-inferiority pathway of five most recent FDA approvals in wet AMD Note: Timeline not to scale. AMD: age-related macular degeneration; DME: diabetic macular edema; q24W, every 12 weeks; q8W, every 8 weeks. Wet AMD DURAVYU single
Slide 7: Phase 3 Wet AMD Program LUGANO and LUCIA Pivotal Trials
Phase 3 Wet AMD Program LUGANO and LUCIA Pivotal Trials
Slide 8: LUGANO & LUCIA Follow Established Non-Inferiority Regulatory Path in Wet AMD
LUGANO & LUCIA Follow Established Non-Inferiority Regulatory Path in Wet AMD Endpoints Primary Endpoint: Non-inferior (NI) mean change in BCVA from Day 1 to Week 52 and Week 56 (blended) vs aflibercept control (NI margin of -4.5 letters) Key Secondary Endpoints: Safety Reduction in treatment burden
Slide 9: Pivotal Phase 3 Program Follows Established Non-Inferiority Regulatory Pathway
Pivotal Phase 3 Program Follows Established Non-Inferiority Regulatory Pathway *> 5 letter drop with 75 microns new fluid from AMD compared to best on study, or new, sight threatening hemorrhage due to wet AMD DURAVYU dosing consists of 2 inserts delivered in a single injection. D, day; W, week; EOS
Slide 10: LUGANO Topline Results
@ EvePoint LUGANO Topline Results “—_
Slide 11: LUGANO: DURAVYU Showed Clinically Meaningful Results to Support a Potential NDA Filing
LUGANO: DURAVYU Showed Clinically Meaningful Results to Support a Potential NDA Filing and Differentiated Profile Preliminary data – pending final analysis Visual Acuity Treatment Burden Safety Continued favorable safety profile with redosing Superior reduction in treatment burden (nominal p-value <
Slide 12: LUGANO Topline Results Baseline Characteristics
LUGANO Topline Results Baseline Characteristics
Slide 13: LUGANO Baseline Characteristics
LUGANO Baseline Characteristics Preliminary data – pending final analysis DURAVYU 2.7mg (n=211) Aflibercept 2mg q8W (n=216) Age (years), mean (SD) 77.5 (7.52) 77.0 (7.61) ≥ 65, n (%) 202 (95.7) 205 (94.9) Female, n (%) 136 (64.5) 141 (65.3) Treatment Naïve, n (%) 159 (75.4) 164 (75.9) Previo
Slide 14: LUGANO Baseline Characteristics (Cont'd)
LUGANO Baseline Characteristics (Cont’d) DURAVYU 2.7mg (n=211) Aflibercept 2mg q8W (n=216) BCVA (ETDRS letters), mean (SD) 65.8 (8.95) 64.3 (10.35) > 20/40 Snellen equivalent1, n (%) 82 (38.9) 79 (36.6) ≤ 20/40 Snellen equivalent1, n (%) 129 (61.1) 137 (63.4) Central CST (um), mean (SD) 319
Slide 15: LUGANO Topline Results Visual Acuity
LUGANO Topline Results Visual Acuity
Slide 16: Primary Endpoint Not Achieved Despite Impressive Anatomic Control
LS Mean Change, in ETDRS letters *Blended week 52 and week 56 change vs. baseline by MMRM BCVA, best-corrected visual acuity; ETDRS, early treatment diabetic retinopathy study; CST, central subfield thickness. Preliminary data – pending final analysis Mean Change in BCVA from Baseline Week Mean Chan
Slide 17: Asymmetric Cohort Driving the Endpoint Result
LS Mean Change, in ETDRS letters *Blended week 52 and week 56 change vs. baseline by MMRM BCVA, best-corrected visual acuity; ETDRS, early treatment diabetic retinopathy study; CST, central subfield thickness. Preliminary data – pending final analysis Mean Change in BCVA from Baseline Week Asymmetri
Slide 18: Patients with ≥15-Letter Vision Loss in LUGANO Aflibercept Arm Up to 10x Lower Than Prior Trials
Patients with ≥15-Letter Vision Loss in LUGANO Aflibercept Arm Up to 10x Lower Than Prior Trials Preliminary data – pending final analysis Cause of Visual Loss in the 9 Patients: Geographic atrophy (n=6) Glaucoma (n=2) Retinal detachment (n=1) 258 letters lost despite good anatomic control 6 receive
Slide 19: Profound Impact of the Asymmetric Cohort (9 Eyes) on VA Outcome
Profound Impact of the Asymmetric Cohort (9 Eyes) on VA Outcome Preliminary data – pending final analysis Mean Change in ETDRS letters Significant Impact of the 9 Eyes on Visual Acuity Week Anatomic Control in Both Groups Mean CST Change in microns Week Asymmetric cohort - 9 patients (4%) Excluding
Slide 20: Supplementation Worked as Expected in Overall Population
Supplementation Worked as Expected in Overall Population –Asymmetric Cohort Did Not Respond to Aflibercept Supplementation Preliminary data – pending final analysis Note: 3/9 patients in asymmetric cohort did not receive supplement. Visit Prior to Supplement Supplement Visit 1st Visit Post-Supplemen
Slide 21: Asymmetric Cohort Did Not Respond to Aflibercept Supplementation
Supplementation Worked as Expected in Overall Population –Asymmetric Cohort Did Not Respond to Aflibercept Supplementation Preliminary data – pending final analysis Note: 3/9 patients in asymmetric cohort did not receive supplement. Visit Prior to Supplement Supplement Visit 1st Visit Post-Supplemen
Slide 22: % of ≥15 Letter Vision Loss in Aflibercept Control Arm Lower than Any Prior Trial
% of ≥15 Letter Vision Loss in Aflibercept Control Arm Significantly Lower than Any Prior Wet AMD Trial *Loss of letters from baseline a. Heier et al. Ophthalmology 2012 (VIEW 1/2), Bayer VIEW combined analysis; b. CADTH Beovu Clinical Review (NBK565336), HAWK/HARRIER wk48. c. ClinicalTrials.gov TEN
Slide 23: Random Reassignment Modeling Achieved Non-Inferiority in Every Simulation
Random reassignment of the 16 LUGANO patients with any ≥15-letter vision loss resulted in DURAVYU non-inferiority in every simulation: 16 Patients with any ≥15-letter vision loss 1 9 NI 10 NI 6 NI 7 NI 8 NI NI NI NI NI 3 2 4 NI 5 Modeled BCVA outcome range: -1.3 to -2.0 NI, non inferiority; BCVA, be
Slide 24: Ad Hoc Analysis Excluding Asymmetric Cohort: Non-Inferiority Achieved
Ad Hoc Analysis Excluding Asymmetric Cohort (9 of 211): Non-Inferiority in BCVA Change from Baseline Was Achieved Preliminary data – pending final analysis LS Mean Change in ETDRS letters Mean Change in BCVA from Baseline, With Asymmetric Cohort (n=9) Removed Week +5.9 +3.5 (nominal non-inferiority
Slide 25: Median Analysis Demonstrates Non-Inferiority
Median Analysis Demonstrates Non-Inferiority Median Regression Reduces Influence of Vision Outliers Median Change in BCVA vs. Aflibercept * -1.4 Preliminary data – pending final analysis Note: Median Regression is more robust than MMRM/ANCOVA to extremes. Analysis performed on all patients with ava
Slide 26: LUGANO Topline Results Reduction in Treatment Burden & Supplement-Free Rates
LUGANO Topline Results Reduction in Treatment Burden & Supplement-Free Rates
Slide 27: DURAVYU Achieved Superiority In Treatment Burden Reduction vs. On-Label Aflibercept
Average Supplements in DURAVYU patients1 DURAVYU Achieved Superiority In Treatment Burden Reduction vs. On-Label Aflibercept Up to Week 56 Preliminary data – pending final analysis Total Injections* After Loading Doses (Avg.) 1. 1.1 average supplemental injection annualized *Participants who discont
Slide 28: Supplement-Free Rates Demonstrate DURAVYU's Potency and Durability
Supplement-Free Rates Demonstrate DURAVYU’s Potency and Durability Preliminary data – pending final analysis DURAVYU 2.7mg Up to Week 32 Up to Week 56 Supplement-Free Patients 76% 54% Patients with 0 or 1 Supplement 96% 79% Patients with 2 or fewer Supplements 99% 88% Note: Although data from the Ph
Slide 29: DURAVYU Non-Inferior to Aflibercept in Supplement-Free Subgroup
DURAVYU was Non-Inferior to On-Label Aflibercept Control In Supplement-Free Subgroup (n=113, 54%) -76 µm -73 µm +6.4 +4.7 (nominal non-inferiority p=0.0035) Preliminary data – pending final analysis LS Mean Change in ETDRS letters Mean BCVA Change from Baseline, Supplement-Free Patients Week Mean CS
Slide 30: LUGANO Topline Results Safety Data
LUGANO Topline Results Safety Data
Slide 31: AE Profile Confirms DURAVYU's Favorable Safety Profile With Repeat Dosing
AE Profile Confirms DURAVYU’s Favorable Safety Profile With Repeat Dosing No cases of: Insert migration into the anterior chamber Anterior chamber opacities Free-floating particles Retinal vasculitis (occlusive or non-occlusive) Severe intraocular inflammation AEs of particular interest – all <1% in
Slide 32: Subjects with Ocular AEs in Study Eye ≥2%
Preliminary data – pending final analysis Subjects with Ocular AEs in Study Eye ≥2% through Week 56 DURAVYU 2.7mg (n=211) Aflibercept 2mg (n=221) Conjunctival haemorrhage 11.4% 5.0% Vitreous floaters 9.0% 3.6% Neovascular age-related macular degeneration 7.1% 1.4% Retinal haemorrhage 4.7% 1.8% Vitre
Slide 33: LUGANO – Evaluation of Geographic Atrophy (GA) Across Cohorts
LUGANO – Evaluation of Geographic Atrophy (GA) Across Cohorts LUGANO Data Supports Assessment that DURAVYU Did Not Influence GA Onset or Progression
Slide 34: LUGANO Data Supports Assessment That DURAVYU Did Not Influence GA Onset or Progression
LUGANO Data Supports Assessment That DURAVYU Did Not Influence GA Onset or Progression Note: TKI mechanism of action, preclinical data, and Phase 2 Davio 2 also supportive of DURAVYU. Calculations determined by masked reading center. GA, geographic atrophy; TKI, tyrosine kinase inhibitor; AE, advers
Slide 35: Phase 2 DAVIO 2: Fewer ≥15-Letter Vision Losses; No GA Observed
Phase 2 DAVIO 2: Fewer ≥15-Letter Vision Losses with DURAVYU; No GA Observed At Week 56 DURAVYU 2mg (47) DURAVYU 3 mg (52) Aflibercept 2mg q8W (52) 15 letter losers 4.3 % 3.8% 7.7 % 15 letter losers from GA 0 0 1 15 letter losers from glaucoma 0 0 0 AE of GA at study end 0 0 1 GA, geographic atrophy
Slide 36: Select Ocular AEs in Study Eye
Select Ocular AEs in Study Eye DURAVYU 2.7mg (N=211) Aflibercept 2mg (N=221) Cataract 4.3% 5.4% Intraocular pressure increased 3.8% 3.2% Intraocular inflammation (IOI) 0.5% 0.5% Dry age-related macular degeneration 2.4% 3.2% Geographic Atrophy1 2.4% 2.7% Dry age-related macular degeneration1 0 0.5%
Slide 37: LUGANO: Onset of New GA Was Greater in Aflibercept Arm
Geographic Atrophy Present by FAF Baseline (n=180 per arm) Week 56 (n=168 per arm) Proportion of Patients (%) with Presence of Macular Atrophy Note: GA progression determined by masked, independent reading center FAF, fundus autofluorescence. 5 % 2 % LUGANO: Onset of New GA Was Greater in Aflibercep
Slide 38: LUGANO: GA Growth Rate Consistent Between Treated and Fellow Eye
DURAVYU Treated Eyes (n=211) Untreated Fellow Eye (n=211) Number of eyes w GA at the start of the study n=14 n=25 Growth rate in mm2 per independent reading center 2 1.7 mm2 1.6 mm2 1. Holz F, et al. JAMA Ophthalmology, 2018. Khanani A, et al., Lancet, 2023. Heier J, et al., Lancet, 2023. Fleckenste
Slide 39: LUGANO: GA Location at Baseline Closer to Fovea in DURAVYU Arm
In DURAVYU eyes, GA started meaningfully closer to fovea at baseline compared to control, therefore at higher risk of losing vision Progression towards fovea was similar between groups Distance from fovea DURAVYU 2.7mg (N=14) Aflibercept 2mg (N=17) At baseline 825 microns 1009 microns Change from Ba
Slide 40: DURAVYU Arm Had Lower Rate of Fibrosis Progression
LUGANO: DURAVYU Arm Had Meaningfully Lower Rate of Fibrosis Progression Versus On-Label Aflibercept Proportion of Patients with Subretinal Fibrosis Present DURAVYU 2.7mg Aflibercept 2mg Baseline 2.8% (6 of 211) 1.4% (3 of 216) Week 56 4.1% (8 of 193) 4.1% (8 of 197) Progression of Fibrosis from Base
Slide 41: Representative Case Studies
Representative Case Studies
Slide 42: Case 1: DURAVYU 2.7 mg Supplement-free Patient with a 13 Letter VA Gain
New Data Case 1: DURAVYU 2.7 mg Supplement-free Patient with a 13 Letter VA Gain Preliminary data – pending final analysis VA, visual acuity; AE, adverse event; SAE; severe adverse event.
Slide 43: Case 1: Hemorrhage Resolved Completely
Day 1 Week 56 VA = 77 letters VA = 90 letters New Data Case 1: DURAVYU 2.7 mg Supplement-free Patient with a 13 Letter VA Gain Hemmorhage at baseline Hemorrhage resolved completely Preliminary data – pending final analysis VA, visual acuity.
Slide 44: Case 1: Leakage Resolved
Day 1 (Screening) Week 56 VA = 77 letters VA = 90 letters New Data Case 1: DURAVYU 2.7 mg Supplement-free Patient with a 13 Letter VA Gain Leakage at baseline Leakage resolved Preliminary data – pending final analysis VA, visual acuity.
Slide 45: Case 1: Well-Controlled Through Week 56
Baseline VA = 77 letters Week 4 VA = 81 letters Week 8 VA = 84 letters Week 12 VA = 85 letters Week 20 VA = 86 letters Week 32 VA = 88 letters New Data Case 1: DURAVYU 2.7 mg Supplement-free Patient with a 13 Letter VA Gain Well-Controlled Through Week 56 Preliminary data – pending final analysis VA
Slide 46: Case 1: Well-Controlled Through Week 56 (cont.)
Week 40 VA = 89 letters Week 44 VA = 89 letters Week 48 VA = 90 letters Week 52 VA = 90 letters Week 56 VA = 90 letters New Data Preliminary data – pending final analysis VA, visual acuity. Case 1: DURAVYU 2.7 mg Supplement-free Patient with a 13 Letter VA Gain Well-Controlled Through Week 56
Slide 47: Case 2: DURAVYU 2.7 mg Supplement-free Pt with GA
New Data Preliminary data – pending final analysis GA, geographic atrophy; VA, visual acuity; AE, adverse event; SAE; severe adverse event.. Case 2: DURAVYU 2.7 mg Supplement-free Pt with GA (VA Loss 15 Letters)
Slide 48: Case 2: GA in Macula
Baseline Week 56 VA = 67 letters VA = 52 letters New Data GA in macula Increased GA in macula Preliminary data – pending final analysis GA, geographic atrophy; VA, visual acuity. Case 2: DURAVYU 2.7 mg Supplement-free Pt with GA (VA Loss 15 Letters)
Slide 49: Case 2: GA Area and Growth Rate
Baseline FAF Week 56 Red Free VA = 67 letters VA = 52 letters GA Area = 1.55 mm2 GA Area = 1.85 mm2 Growth rate = 0.30 mm2 Note: Reading center measurements. GA, geographic atrophy; VA; visual acuity. Preliminary data – pending final analysis New Data Case 2: DURAVYU 2.7 mg Supplement-free Pt with G
Slide 50: Case 2: Visual Acuity Over Time
Case 2: DURAVYU 2.7 mg Supplement-free Pt with GA (VA Loss 15 Letters) Baseline Week 4 Week 8 Week 12 Week 20 Week 32 VA = 67 letters VA = 70 letters VA = 66 letters VA = 69 letters VA = 61 letters VA = 71 letters New Data Preliminary data – pending final analysis GA, geographic atrophy; VA, visual
Slide 51: Case 2: Visual Acuity Over Time (cont.)
Week 40 Week 44 Week 48 Week 52 Week 56 VA = 60 letters VA = 55 letters VA = 59 letters VA = 50 letters VA = 52 letters New Data Preliminary data – pending final analysis GA, geographic atrophy; VA, visual acuity. Case 2: DURAVYU 2.7 mg Supplement-free Pt with GA (VA Loss 15 Letters)
Slide 52: Conclusions & Next Steps
@ EvePoint Conclusions & Next Steps “—_
Slide 53: LUGANO: Clinically Meaningful Results, Commercially Impactful Opportunity
SECONDARY ENDPOINTS: Safety Reduction in treatment burden (superiority vs on-label aflibercept) Percent of eyes supplement-free Anatomic stability ~ 42% reduction -superior to SOC (nominal p<0.0001) 79% received zero or 1 supplement Only 4 microns difference confirms potency Favorable safety profile
Slide 54: Key Takeaways from LUGANO Trial
Key Takeaways from LUGANO Trial 1 Clinically relevant Phase 3 results against SOC on-label comparator 2 Only sustained-delivery TKI with Phase 3 repeat-dose safety 3 Topline result driven by imbalance of ≥15-letter losses in control arm, despite DURAVYU activity 4 Regression-to-the-mean potential su
Slide 55: Strategy for NDA Filing in H1 2027, Provided Positive LUCIA Results
Strategy for NDA Filing in H1 2027, Provided Positive LUCIA Results 1 Pre-NDA meeting in Q4 2026 based on totality of data 2 Multiple precedents for NDA approval in ophthalmology following mixed results across two well-controlled Phase 3 trials 3 Strong secondary endpoints of safety, treatment burde
Slide 56: Upcoming DURAVYU Milestones Through 2027
Report topline data simultaneously for both pivotal DME trials, COMO and CAPRI Engage FDA to discuss Wet AMD data package Submit comprehensive Phase 3 data package (LUGANO & LUCIA) to FDA Includes learnings from LUGANO for the LUCIA analysis plan, ahead of topline results Report topline data from th
Slide 57: LUGANO Phase 3 Clinical Trial DURAVYU in Wet AMD Expanded Results & Analyses
LUGANO Phase 3 Clinical Trial DURAVYU in Wet AMD Expanded Results & Analyses | September 2026