Nova Eye Medical Ltd · ASX:EYE
Nova Eye Medical — Investor Presentation (September 2018)
18 slides from Nova Eye Medical's investor presentation, Sep 21, 2018
Slide 1: Results of LEAD Clinical Trial in Intermediate AMD
RESULTS OF LEAD CLINICAL TRIAL IN INTERMEDIATE AMD INVESTOR PRESENTATION TOM SPURLING, CHRIS BAKER 21 SEPTEMEBER 2018
Slide 2: Disclaimer
2 LEAD CLINICAL TRIAL: ASX ELX DISCLAIMER This presentation has been prepared by Ellex Medical (Ellex, ELX: ASX). While the information in this presentation has been prepared in good faith and with reasonable care, no representation or warranty, express or implied, is made as to the accuracy, adequa
Slide 3: Contents
3 LEAD CLINICAL TRIAL: ASX ELX Contents • Overview of LEAD Clinical Trial • Overview of Intermediate Age-related Macular Degeneration (iAMD) • Overview of Ellex 2RT® Therapy • Key Results from LEAD contained in Ophthalmology Scientific Publication • Trial Conclusions • Market Dynamics and Commercial
Slide 4: Overview of LEAD Clinical Trial
4 LEAD CLINICAL TRIAL: ASX ELX Overview of LEAD Clinical Trial The LEAD trial has validated the safety and efficacy of Ellex 2RT® as an intervention for many people with intermediate AMD. • Double-masked, randomised, sham-controlled trial over • Largest ever randomised study conducted in iAMD 36 mon
Slide 5: Overview of iAMD
5 LEAD CLINICAL TRIAL: ASX ELX Overview of iAMD AMD (“Age-Related Macular Degeneration”): iAMD AND THE LEAD TRIAL • leading cause of blindness in the developed world • One of the goals of the LEAD • affects one in seven Australians over the trial was to examine whether age of 501 Ellex 2RT® could de
Slide 6: Health of Retina & Macula
6 LEAD CLINICAL TRIAL: ASX ELX Indication of retinal Apply Ellex 2RT® health failing, as shown nanopulse laser light in retinal imaging therapy Good/Normal HEALTH OF RETINA & MACULA Ellex 2RT® to slow Defer injection in eye Disease progression without Ellex 2RT® disease progression Requiring anti-VE
Slide 7: Overview of Ellex 2RT
7 LEAD CLINICAL TRIAL: ASX ELX Overview of Ellex 2RT® Ellex 2RT® is Ellex’s proprietary, patented laser therapy that stimulates the eye's natural healing response to treat the ELLEX 2RT® LASER early stages of AMD. • Specially designed rapid nanosecond pulse, non-thermal laser intervention targeting
Slide 8: Consort Diagram
8 LEAD CLINICAL TRIAL: ASX ELX Assessed for eligibility (n=367) Consort Diagram Excluded (n=75) Did no meet inclusion criteria (n=48) Enrollment Declined to participate (n=4) • 79.6% of patients assessed were Other reasons (n=23) randomised into trial Randomised (n=292) • Intent-to-Treat (ITT) analy
Slide 9: Patient Baseline Characteristics
SNL treatment Sham treatment 9 LEAD CLINICAL TRIAL: ASX ELX (n=147) (n=145) Demographics Age (years) 70·3 (7·0) 69·8 (8·1) Prof. to provide high res copy] Patient Baseline Sex (female) Ethnicity (Anglo-Saxon) 103 (70·1%) 134 (91·2%) 112 (77·2%) 128 (88·3%) Characteristics Smoking history Never 77 (5
Slide 10: Safety
SNL treatment Sham treatment (n=147) (n=145) 10 LEAD CLINICAL TRIAL: ASX ELX Definitely related ocular adverse events Participants reporting one or more adverse events 15 (10·2%) 1 (0·7%) After-images* 5 (3·4%) 1 (0·7%) Retinal haemorrhage 10 (6·8%) 0 (0·0%) Safety Possibly related ocular adverse ev
Slide 11: Primary Endpoint Results
11 LEAD CLINICAL TRIAL: ASX ELX Primary Endpoint Results • No significant difference in INTENT TO TREAT (ITT) PER PROTOCOL (PP) progression to late AMD under ITT analysis (p=0.122) or the PP Adjusted HR: 0·61 SNL analysis (p=0.092) (95% CI 0·33–1·14) Sham Cumulative proportion • At 36 months, 13.6%
Slide 12: Treatment Effect on Late AMD
12 LEAD CLINICAL TRIAL: ASX ELX Treatment Effect on Late AMD Endpoint Events / Total SNL Sham Adjusted Hazard Ratio (95% CI) Intention-to-treat (n = 292) Late AMD 20/147 25/145 0·61 (0·33–1·14) • Estimated effect on Forest plot of 2RT ® Neovascular AMD 7/147 5/145 1·21 (0·37–3·93) examining the two
Slide 13: Patients without RPD at Baseline - Analysis
13 LEAD CLINICAL TRIAL: ASX ELX Patients without RPD at Baseline - Analysis • A clinically meaningful 77% INTENT TO TREAT (ITT) PER PROTOCOL (PP) reduction in the risk of progression (HR=0.23) in patients who A Drusen Without RPD at baseline received 2RT® versus sham Adjusted HR: 0·23 SNL (95% CI 0·
Slide 14: Patients with RPD at Baseline - Analysis
14 LEAD CLINICAL TRIAL: ASX ELX Patients with RPD at Baseline - Analysis • Increased rate of progression to INTENT TO TREAT (ITT) PER PROTOCOL (PP) late-stage AMD in the 2RT ® treatment group compared to the sham treatment group, although the treatment effect was not significant (p=0.112 for ITT and
Slide 15: LEAD Trial Conclusions
15 LEAD CLINICAL TRIAL: ASX ELX LEAD Trial Conclusions • Though the primary endpoint across the • RPD negative sub group represents entire study cohort was not met, Ellex 2RT ® approximately 75% of all iAMD patients displayed an exceptional safety profile with bilateral large drusen and no geographi
Slide 16: Market Dynamics and Commercial Opportunity
16 LEAD CLINICAL TRIAL: ASX ELX Market Dynamics and Commercial Opportunity • Publication in Ophthalmology, the most important • Future regulatory clearances in the US, Japan peer-reviewed ophthalmology journal globally, and China will increase the pool of treatable underscores the significance of th
Slide 17: Thank You
17 LEAD CLINICAL TRIAL: ASX ELX THANK YOU
Slide 18: Q/A Session
18 LEAD CLINICAL TRIAL: ASX ELX Q/A SESSION
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