Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Corporate Update (January 2019)
13 slides from Hyperion Defi's corporate update, Jan 30, 2019
Slide 1: Making it Possible: MIST-1 Topline Results
Making it Possible MIST - 1 Topline Results January 30 th , 2019
Slide 2: Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this presentation are forward - looking statements . Forward - looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictio
Slide 3: Pharmacologic Mydriasis: ~80M office administrations and ~4M surgical per year in US
• Pharmacologic mydriasis, or dilation of the pupil of the eye with drugs, is the cornerstone of today’s ophthalmic/optometric care • Indispensable part of: – Comprehensive Eye Exam – Diabetic Retinal Exam – Macular Degeneration Retinal Exam – Retinopathy of Prematurity Screening • Current eyedroppe
Slide 4: Why should we be concerned about overdosing with eye drops?
Why should we be concerned about overdosing with eye drops? • Many eye drugs are compounds that were designed for cardiovascular or other systemic effects (beta blockers, phenylephrine and others) • When these drugs are overdosed to eye, they can seep into systemic circulation through periocular abs
Slide 5: Designed for mydriatic exams performed every year in the United States
Designed for the estimated 80 million mydriatic exams performed every year in the United States and the estimated 4 million pharmacologic mydriasis applications for cataract surgery • Current eyedropper paradigm is approximately 100 year old • Legacy technology can be inefficient, wasteful and impre
Slide 6: Eyenovia's Optejet technology designed to revolutionize ophthalmic drug delivery
• Eyenovia’s OpteJet ™ technology is designed to revolutionize ophthalmic drug delivery • We believe our piezo - print micro - dosing can increase efficiency, precision and reduce waste • The Optejet aims to eliminate ocular overdose to the ocular surface 5 MicroStat Smart … Precise … Brilliant
Slide 7: Eyenovia's Optejet: 21st century platform for smarter eyecare
6 Eyenovia’s Optejet: 21st century platform for smarter eyecare…
Slide 8: EYE 102 Phase II Trial demonstrated advantages of microdosing
• Comparable clinical efficacy with ¼ the dose of traditional eye drops • Significant improvement in tolerability and systemic exposure for same formulation microdose versus eye drops 7 EYE 102: Phase II Trial demonstrated the advantages Eyenovia’s microdosing approach 4x PE Eye Drop 1x PE µD ( p=0.
Slide 9: Registration Program: Two Phase 3 Superiority Studies
• Double - masked, active - controlled, cross - over design • MIST - 1 (N64 randomized):µD phenylephrine - tropicamide vs µD tropicamide vs µD phenylephrine • MIST - 2 (N70 randomized):µD phenylephrine - tropicamide VS µD placebo 8 MicroStat Registration Program: Two Phase 3 Superiority Studies (MIS
Slide 10: Results: Primary Endpoint Analysis
1. 64 subjects randomized 2. MIST - 1 met primary efficacy endpoint: pupil dilation change from Baseline at 35 minutes 3. Statistically larger 35 minute dilation for MicroStat vs components 4. Additional outcomes: • 94% of eyes achieved 6 mm or greater pupil dilation at 35 minutes compared with 78%
Slide 11: Results: Other Efficacy Results
Highest proportions of pupil diameter values above 6.0mm observed in the combination solution group 10 MIST - 1 Results: Other Efficacy Results Comb. vs Trop. p=0.018 Comb. vs Phen . p<0.001
Slide 12: Results: Safety Results
• Treatment emergent adverse events were ocular, related to mydriasis, mild and transient • No non - ocular adverse events 11 MIST - 1 Results: Safety Results
Slide 13: Making it Possible: Topline Results
Making it Possible MIST - 1 Topline Results January 30 th , 2019