Nova Eye Medical Ltd · ASX:EYE
Nova Eye Medical — Investor Presentation (October 2024)
20 slides from Nova Eye Medical's investor presentation, October 2024
Slide 1: 2RT – Potential Breakthrough Treatment of Macular Degeneration (AMD)
2RT® – Potential Breakthrough Treatment of Macular Degeneration (AMD) October 2024 AlphaRET a wholly owned subsidiary of Nova Eye Medical Limited
Slide 2: Executive Summary of 2RT opportunity
Executive Summary of 2RT® opportunity 9 • AMD affects over 200m people globally, 14 million in US and is the leading cause of blindness of the elderly population. • 2RT® is a laser-based treatment that addresses the root cause of AMD and offers advantages over traditional drug therapy. • 2RT® treatm
Slide 3: Introduction to Macular Degeneration (AMD)
Introduction to Macular Degeneration (AMD) • AMD is a degenerative retinal disease causing progressive vision distortion with loss of central vision Atrophy loss and eventual blindness. • AMD is graded into Early, Intermediate and Late stages • Patient genetics determine disease course with late- st
Slide 4: Current AMD Treatment Paradigm
Current AMD Treatment Paradigm • Current treatments for wet AMD supress symptoms. • Drug treatment starts AFTER VISUAL DECLINE occurs and treatment does regain some vision but within 5 years the patient’s vision is severely impaired. • Drug treatment involves monthly injections in a sterile injectin
Slide 5: Vision Loss Associated with Wet AMD Drug Treatment
Vision Loss Associated with Wet AMD Drug Treatment Anti-VEGF injections Normal Vision Injections every 4 weeks Driving Vision Injections every 6-8 weeks Legally Blind (Letters) Vision loss without treatment Vision loss These graphs are constructed from data derived from: without treatment Marina and
Slide 6: 2RT Treatment Overview
2RT® Treatment Overview • 2RT® is a patented therapy using a nanosecond ultra short pulsed laser (USPL) and unique pixelated laser beam profile that uses intra- cellular cavitation to stimulate rejuvenation of “Based on the LEAD study RPE cells. outcomes, 2RT® is currently a leading candidate treatm
Slide 7: AMD – Failing Hydraulic Conductivity of Bruch's Membrane
AMD – Failing Hydraulic Conductivity of Bruch’s Membrane AMD results in the loss of hydraulic conductivity of Bruch’s Membrane, with a progressive accumulation of drusen leading to the metabolically insufficiency of the neuro-retina • Bruch’s, is a limiting membrane, supported by the RPE cells to ma
Slide 8: Mechanism of Action of 2RT Laser
Mechanism of Action of 2RT® Laser • Laser light spikes absorbed by melanin causes intracellular cavitation. • Activated immune response, stimulates removal of damaged cells and drusen without inflammation or necrosis. • Apoptosis and mitosis results in reduction of drusen load, restoring RPE and Bru
Slide 9: Regulatory Approvals for 2RT
Regulatory Approvals for 2RT® 8 • Europe and Mutual Recognition Jurisdictions, CE Mark (including Switzerland, UK, Australia, NZ) - 2RT® is approved for the treatment of early AMD, to improve macular function and appearance in early AMD. • Europe and Mutual Recognition Jurisdictions, CE Mark (includ
Slide 10: LEAD study design and development path
n = 292 participants with bilateral large drusen Sham 2RT (n = 145) (n = 147) One study eye, treatment every 6 months 6 monthly follow-up, for 36 month period 5 Sites in Australia, 1 Site in Northern Ireland Proof-of-concept study of efficacy and safety In Vitro Mouse Human Pilot Clinical LEAD Rando
Slide 11: LEAD Primary Endpoint
LEAD Primary Endpoint – Onset of late stage determined with multi-modal imaging Neovascular AMD Drusen-Associated Atrophy (any of the following) Lesions on Fluorescein Angiography Colour Fundus Photography Fundus Autofluorescence (FAF) Optical Coherence Tomography (or subretinal haemorrhage + fluid)
Slide 12: LEAD Results Comparison - Primary Outcome to 3 years
LEAD Results Comparison - Primary Uutcome to 5 years LEAD Primary outcome Post Hoc - RPD patients excluded (24% of study population) • At the time of protocol development, the pathological impact • Significant reduction in progression compared with Sham of Reticular Pseudodrusen (RPD) was not unders
Slide 13: LEAD Study Informs Confirmatory Pivotal Study Design
LEAD Study Informs Confirmatory Pivotal Study Design Trial: LEAD1 study conducted by the Centre for Eye Research Australia (Melbourne), a 292 patient cohort treated with 2RT from 2012-2018 with follow up through to 2020. Results: 77% in Total cohort without RPD Reduction Post-hoc analysis demonstrat
Slide 14: LEAD 5-Year Summary
LEAD 5 - Year Summary ▪ Delay of Late AMD compared with untreated cohort. ▪ Conversion to Wet AMD significantly reduced. ▪ Sustained beneficial 2RT treatment effect for those without coexistent RPD out to 5 years. | 14
Slide 15: Excluding Reticular Pseudodrusen (RPD)
Excluding Reticular Pseudodrusen (RPD) • Scattered drusenoid deposits located in sub-retinal space • Detrimental effect on RPE health • Patients with RPD are at high risk for progression to late AMD • RPD presents as “haystack” appearance on OCT (yellow circle) • RPD presents as ribbon or net-like p
Slide 16: Visual Acuity: Vision Loss with Wet AMD
Vision Loss with Wet AMD 90 Normal Vision 80 Driving Vision 70 60 Visual Acuity Legally Blind 50 40 LEGEND 30 Early Intermediate AMD Nat. History vision loss Late AMD AMD Vision loss with Anti-VEGF Injection 20 10 No vision loss Progressively declining vision 0 65 75 85 95 Age (Years) nova-eye.com |
Slide 17: Visual Acuity: Vision Loss Delayed with 2RT
Vision Loss Delayed with 2RT Treatment 90 Normal Vision 80 Driving Vision 70 60 Visual Acuity Legally Blind 50 40 LEGEND 30 Early Intermediate AMD Nat. History (Wet AMD) Late AMD AMD Wet AMD Injection 20 10 Vision Loss Delayed with 2RT 0 65 75 85 95 Age (Years) nova-eye.com | 17
Slide 18: Visual Acuity: Vision Loss Further Delayed with 2RT
Vision Loss Further Delayed with 2RT Further Treatment 90 Normal Vision 80 Driving Vision 70 60 Visual Acuity Legally Blind 50 40 LEGEND 30 Early Intermediate AMD Nat. History (Wet AMD) Late AMD AMD Wet AMD Injection 20 10 Vision Loss Further Delayed with 2RT 0 65 75 85 95 Age (Years) nova-eye.com |
Slide 19: Addressable Population
Addressable Population A major opportunity with widespread implications Intermediate stage – 2RT ® ® Late stage - drugs 54 million1 15 million 14 million Nutraceuticals are Addressable currently Dry AMD recommended but by 2RT® Wet AMD are ineffective 2 No current ▪ Australian PBS A$0.7 billion (3) ▪
Slide 20: Nova Eye Medical
ac NOVAEYE MEDICAL.
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