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We believe that….
Myopia is a treatable disease
Early intervention is imperative
A novel approach is needed
Robust clinical data is essential
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The Myopia Epidemic
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5B>4.5x3x
25%
>40%
70’s 00’s80’s 90’s
CAUSED BY MODERN
LIFESTYLE
60x
Vitale S, Sperduto RD, Ferris FL. Increased prevalence of myopia in the United States between 1971-1972 and 1999-2004. Arch Ophthalmol. 2009; 127:1632–39. Holden BA, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050. Ophthalmology 2016; 123:1036–42. Flitcroft DI. The complex interactions of retinal, optical and environmental factors in myopia aetiology. Prog Retin Eye Res. 2012;31(6):622-60.Ruiz-Moreno JM, Quintás FLL. Retinal Detachment and High Myopia. CRSTEurope Apr 2008.
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Myopic Maculopathy Meta-Analysis (Bullimore)
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Goal of Myopia Control Therapy
Reduce the progression of
myopia
Decrease risk of myopia-related
eye disease
Provide better eye care!
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HIGH MYOPIA
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Doctors’ Attitude on Fitting Contact Lenses
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American Optometric Association (2010). Children & Contact Lenses. Retrieved from https://www.aoa.org/documents/npr10520_executivesummarychildrenandcontactlensesstudy_final.pdf
2.9%
22.6%
51.2%
12.4%
11.9%
0% 10% 20% 30% 40% 50% 60%
15-17
13-14
10-12
8-9
<8
Percentage of Responding Optometrists (n=576)
Age
Gro
up
APPROPRIATE AGE TO INTRODUCE SOFT CONTACT LENSES
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Early Therapeutic Intervention is Absolutely CriticalSpectacles are needed such that therapy can be
started prior to contact lens usage
-7
-6
-5
-4
-3
-2
-1
0
1
2
3
4 6 8 10 12 14 16 18
Sphe
rical
Equ
ival
ent R
efra
ctio
n (D
)
Age (Years)
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HIGH MYOPIA 1D⇩3D⇩
Myopia ControlContact Lenses
Myopia ControlSpectacles
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Our Technology Based on a Novel Mechanism
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• Our research indicates that eye growth is stimulated by contrast-signaling retinal neurons
• SightGlass Vision’s Diffusion Optics Technology spectacles control retinal contrast
• Only myopia control technology based on a genetics discovery
• Mechanism not based on peripheral defocus
– Not influenced by viewing distance
– Applicable for both contact lenses and spectacles
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Previous Clinical Trials – Efficacy Demonstrated• Two separate clinical trials have demonstrated reduced myopia
progression with SightGlass lenses– PALM (n=20): Contralateral, controlled clinical trial– ELM (n=135): Randomized, controlled, 3-arm parallel group trial
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ControlLens
SightGlassLens
ControlLens
SightGlassLens
*p=0.0019
Average Axial LengthGrowth Rate (𝜇𝜇m/day)
PALM study results
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SightGlass Vision Clinical Development Program
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• PALMCompleted pilot study (n=20)
• ELMCompleted, multi-center, proof-of-concept study (n=135)
• SPRUCEOngoing, long-term study (n=8)
• WALNUTCompleted, short-term tolerability study (n=21)
• CYPRESSOngoing, 3-year, multi-center, pivotal study (n≈255)
• CHERRYOngoing, long-term, choroidal thickness study (n=tbd)
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CYPRESS Pivotal Clinical Trial Underway
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Study title Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study (CYPRESS)Subjects N=255, 6-10 year old myopes who are between -0.75 and -4.50 D
Study Design 3-year, prospective, controlled, double-masked, 3-arm parallel group trial with 1:1:1 randomization, with age and baseline myopia balanced across arms
Arms Two treatment arms (n=85 each) and a control arm (n=85)
Sites 14 sites (13 US, 1 Canadian) – mixture of academic and private practice sites
Assessments Clinical assessments include:• Observer-masked HAAG-STREIT LENSTAR ocular biometry• Observer-masked cycloplegic Grand Seiko autorefraction• Low/high-contrast logMAR VA at distance and near• Stereopsis, color vision, and peripheral VA• Automated scotopic, low mesopic, and high mesopic pupil size• In-office, electronic parent and subject questionnaires• At-home, electronic assessment of compliance (every 2 weeks)
Co-primary Endpoint
Includes analyses of:• Axial length change from baseline• Cycloplegic autorefraction change from baseline
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Upcoming Company Milestones
2019• Complete enrollment of pivotal CYPRESS trial• Present results of clinical tolerability trial
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2020• 12-month data from pivotal CYPRESS trial
