Joe Rappon, OD, MS, FAAO Chief Medical Officer

Transcription

1 Joe Rappon, OD, MS, FAAO Chief Medial Offier

2 We believe that. Myopia is a treatable disease Early intervention is imperative A novel approah is needed Robust linial data is essential 2

3 The Myopia Epidemi 25% >40% 5B CAUSED BY MODERN LIFESTYLE 70 s 80 s 90 s 00 s 3x >4.5x 60x Vitale S, Sperduto RD, Ferris FL. Inreased prevalene of myopia in the United States between and Arh Ophthalmol. 2009; 127: Holden BA, et al. Global prevalene of myopia and high myopia and temporal trends from 2000 through Ophthalmology 2016; 123: Flitroft DI. The omplex interations of retinal, optial and environmental fators in myopia aetiology. Prog Retin Eye Res. 2012;31(6): Ruiz-Moreno JM, Quintás FLL. Retinal Detahment and High Myopia. CRSTEurope Apr

4 Myopi Maulopathy Meta-Analysis (Bullimore) 4

5 Goal of Myopia Control Therapy HIGH MYOPIA Redue the progression of myopia Derease risk of myopia-related eye disease Provide better eye are! 5

6 Dotors Attitude on Fitting Contat Lenses APPROPRIATE AGE TO INTRODUCE SOFT CONTACT LENSES <8 11.9% % Age Group % % % 0% 10% 20% 30% 40% 50% 60% Perentage of Responding Optometrists (n=576) Amerian Optometri Assoiation (2010). Children & Contat Lenses. Retrieved from 6

7 Early Therapeuti Intervention is Absolutely Critial Spetales are needed suh that therapy an be started prior to ontat lens usage 3 Spherial Equivalent Refration (D) Myopia Control Spetales HIGH MYOPIA Myopia Control Contat Lenses 3D 1D Age (Years) 7

8 Our Tehnology Based on a Novel Mehanism Our researh indiates that eye growth is stimulated by ontrast-signaling retinal neurons SightGlass Vision s Diffusion Optis Tehnology spetales ontrol retinal ontrast Only myopia ontrol tehnology based on a genetis disovery Mehanism not based on peripheral defous Not influened by viewing distane Appliable for both ontat lenses and spetales 8

9 Previous Clinial Trials Effiay Demonstrated Two separate linial trials have demonstrated redued myopia progression with SightGlass lenses PALM (n=20): Contralateral, ontrolled linial trial ELM (n=135): Randomized, ontrolled, 3-arm parallel group trial PALM study results Average Axial Length Growth Rate (μμm/day) Control Lens SightGlass Lens *p= SightGlass Lens Control Lens 9

10 SightGlass Vision Clinial Development Program PALM Completed pilot study (n=20) ELM Completed, multi-enter, proof-of-onept study (n=135) SPRUCE Ongoing, long-term study (n=8) WALNUT Completed, short-term tolerability study (n=21) CYPRESS Ongoing, 3-year, multi-enter, pivotal study (n 255) CHERRY Ongoing, long-term, horoidal thikness study (n=tbd) 10

11 CYPRESS Pivotal Clinial Trial Underway Study title Subjets Study Design Arms Sites Assessments Co-primary Endpoint Control of Myopia Using Peripheral Diffusion Lenses: Effiay and Safety Study (CYPRESS) N=255, 6-10 year old myopes who are between and D 3-year, prospetive, ontrolled, double-masked, 3-arm parallel group trial with 1:1:1 randomization, with age and baseline myopia balaned aross arms Two treatment arms (n=85 eah) and a ontrol arm (n=85) 14 sites (13 US, 1 Canadian) mixture of aademi and private pratie sites Clinial assessments inlude: Observer-masked HAAG-STREIT LENSTAR oular biometry Observer-masked yloplegi Grand Seiko autorefration Low/high-ontrast logmar VA at distane and near Stereopsis, olor vision, and peripheral VA Automated sotopi, low mesopi, and high mesopi pupil size In-offie, eletroni parent and subjet questionnaires At-home, eletroni assessment of ompliane (every 2 weeks) Inludes analyses of: Axial length hange from baseline Cyloplegi autorefration hange from baseline 11

12 Upoming Company Milestones 2019 Complete enrollment of pivotal CYPRESS trial Present results of linial tolerability trial month data from pivotal CYPRESS trial 12

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