Downloaded 14 times
Uploaded byHealthegy
Revision Optics
This document discusses the Raindrop treatment for presbyopia, which involves placing a small hydrogel inlay under the cornea's surface to improve near and intermediate vision. It provides data on the large market opportunity for presbyopia treatments, details on the Raindrop inlay design and mechanism of action, and clinical trial results demonstrating improvements in near/intermediate vision, visual symptoms, night driving, and patient satisfaction. The regulatory and clinical trial timelines are outlined, as well as the commercial strategy for an international launch following US approval.
More Related Content
Revision Optics
- 1.
- 2. Treatment of Presbyopia CAUTION: Investigationaldevice. Limited by U.S. (Federal) law to investigational use.
- 3. Raindrop U.S. MarketOpportunity (2020) Geography Total Pop. (M) Presbyopes Age 40-64 (M) US 335 105 Wealthy Nations + China/India 3,811 1,580 Global 7,630 2,107 Sources: Market Scope 2014 Report: Global Presbyopia Surgery Market, extrapolated from 2019 to 2020; US Census Bureau * People between the ages of 40 and 64 years old, +1.0 D to -0.5 D MRSE 30,000,000 Population With Approved Raindrop Indication*
- 4. Raindrop Near VisionInlay 2 mm Diameter - 30 µm Thick Hydrogel - 80% Water Clear Enables Max. Light Transmission Placed In One Eye Only Under Femtosecond Laser Flap Same Refractive Index As Cornea Removable
- 5. Mechanism of Action Raindrop~32 µm Flap Bed Bowman’s Layer Anterior Cornea Profocal Cornea Improves Near and Intermediate Vision Change Anterior Curvature of Cornea
- 6. One Raindrop…Multiple Indications AllAbove Indications Able To Be Treated By Raindrop Near Vision Inlay (1 SKU) MYOPE HYPEROPE POST LASIK EMMETROPE PSEUDOPHAKE
- 7. Outstanding Visual Results(Treated Eye) Preop: 0% ≥ 20/25 Near Preop: 18% ≥ 20/25 Intermediate Preop: 99% ≥ 20/25 Distance Postop: 88% ≥ 20/25 Postop: 76% ≥ 20/25 Postop: 71% ≥ 20/25100% - 20/25 Binocular US IDE Data on file: N: 344 @ 24 Months (Treated Eye)
- 8. Low Visual Symptoms:Glare 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Absent Mild Moderate Marked Severe %ofSubjects Self Reported Grading Pre-Op 24 Months Preop 24 Months US IDE Data on file: N: 344 @ 24 Months
- 9. Low Visual Symptoms:Halos 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Absent Mild Moderate Marked Severe %ofSubjects Self Reported Grading Pre-Op 24 Months Preop 24 Months US IDE Data on file: N: 344 @ 24 Months
- 10. Excellent Night DrivingPerformance 78% 18%No difficulty at all A little diff Moderate diff A lot of diff Difficulty Driving at Night? Preop 96% Little to NO Difficulty 67% 24% Postop 91% Little to NO Difficulty A little difficulty Moderate difficulty A lot of difficulty US IDE Data on file: N: 344 @ 12 Months
- 11. Appearance Matters 9% 12% 29%27% 13% 10% Completely Satisfied VerySatisfied Somewhat Satisfied Somewhat Dissatisfied Very Dissatisfied Completely Dissatisfied In terms of your appearance, how satisfied are you with the correction you have? Preop 21% Completely/Very Satisfied 82% 12% 24M 94% Completely/Very Satisfied US IDE Data on file: N: 344 @ 24 Months
- 12. Completey Satisfied Very Satisfied SomewhatSatisfied Somewhat Dissatisfied Very Dissatisfied Completely Dissatisfied Compelling Patient Satisfaction US IDE Data on file: N: 344 @ 24 Months PREOP QUESTION: How satisfied are you with the glasses, contact lenses, or magnifier, or other type of correction you have? POSTOP QUESTION: How satisfied are you with the correction (corneal inlay surgery) you have? 11% 15% 40% 18% 10% 6% PREOP How Satisfied Are You With Your Correction? 24M 45% 26% 16% 7% 87% Completely/Very Satisfied66% Completely/Very Satisfied
- 13. Regulatory Timeline Module 1 Closed Target Panel Q2‘16 Target APPROVAL Q4 ‘16 Module 1 Closed Target Panel Q2 ‘16 Module 4 Submitted Module 2 Closed Module 3 Submitted
- 14. Raindrop Pseudophake IDETrial PSEUDOPHAKE + Monofocal AccommodatingToric
- 15. Raindrop Pseudophake Performance 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 20/20or better 20/25 or better 20/32 or better 20/40 or better %ofSubjects UCDVA UCIVA UCNVA AMO Alcon B & L Staar Aaren Sci Treated Eye at 6 Months
- 16. Low Visual Symptoms 77% 15% 8% Halos AbsentMild Moderate 77% 23% Glare Treated Eye at 6 Months
- 17. Pseudophake Investigator Team EricDonnenfeld, MD Stephan Lane, MD Jonathan Solomon, MDCathleen McCabe, MD Vance Thompson, MD Robert Cionni, MD Greg Parkhurst, MD John Hovanesian, MDRalph Chu, MD Robert Weinstock, MD Jeff Whitman, MDDan Tran, MD Bill Wiley, MD Roger Steinert, MD Medical Monitor Doug Koch, MD
- 18. OUS Commercial Strategy KOL Focus CompetitiveComparative Evaluations Peer Review Publications Podium Presentations Europe Asia Registration Italy PREPARATION… US LAUNCH
- 19.
- 20. The Raindrop Solution ExcellentFunctional Vision • Near • Intermediate • Distance WOW Effect High Patient Satisfaction Expanding Indications Excellent Regulatory Momentum