20 YEARS OF REAL-WORLD CLINICAL USAGE IN DENMARK, WITH NIL REPORTED ADVERSE EFFECTS
World's First Clinical Phase-III Ready Oral Therapeutic For Paediatric Myopia Progression Control - Effectively Prevents High Myopia.
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World's 1st solid oral tablet (ND10) formulation for Myopia control in children
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ND10 increases the biomechanical strength of the sclera and prevents eye elongation to inhibit myopia progression
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Only phase-3 ready drug for myopia progression control in advanced stage of development
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75% reduction in myopia progression
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Compelling safety profile
One-fifth of blindness worldwide is due to refractive error, predominantly myopia
It's a lifestyle disorder.
The intricate connection between lifestyle factors and myopia is a challenge in children that leads to the progressive deterioration of myopia as they grow older:
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Prolonged near activities
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Higher education levels
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Spending less time outdoor
Early detection is key.
Myopia progression in fastest in younger children (ages 7-10). There is lots of evidence for starting myopia control treatments from ages 6-8 years, and some evidence for starting from age 4. The prevalence of uncorrected refractive errors is high among children, so early detection and treatment is essential to avoid irreversible vision loss in the future and potential school problems.
Not just a front-of-the-eye disease.
Myopia is commonly misunderstood as a front-of-the-eye disease, but in fact is a back-of-the-eye diseases due to the physical elongation of the eyeball that increases axial length, which is why refractive error occurs.
Myopia can't be cured after age 18.
As we reach the age of 18, collagen fibrils in the eye naturally crosslink, forming chemical bonds with adjacent fibrils, stiffening the cornea. Myopia patients experience additional stretching of the eye before crosslinking takes place, and after 18 years, that additional elongation cannot be corrected.
GAPS IN MYOPIA LANDSCAPE
"In contrast, drugs for myopia have few options and uncertain efficacy, such as atropine. Previous studies have proved that low-concentration atropine has a clear control effect on the onset and progression of myopia in children. However, some researchers question the long-term effectiveness of atropine in slowing myopia progression or axial elongation in America and Asia. Research also showed that the myopia progression rate rebounds after stopping atropine eye drops in a concentration-dependent manner. In addition, side effects like blurred vision, photophobia, and reduced accommodation are also reported to be accompanied by atropine."
All current treatments treat refraction in the front of the eye which only provides temporary relief
No drug other than atropine and IVMED in clinical development
Compliance of atropine drops is limited
Current Treatment Landscape
Optical devices
Efficacy: maximum effect ever demonstrated by an optical device is around 1 diopter less myopia progression over 7 years.
Drawbacks: Compliance, cost prohibitive, risk of infection, discomfort and dry eye.
Studies: COMET, ROMIO, LORIC, MCOS, BLINK, MiSight One Day Contact Study.
Topical medication
Efficacy: conflicting and insignificant treatment effect.
Drawbacks: Blurred vision, photophobia, stinging in dry mouth and throat.
Studies: PEDIG, CHAMP, ATOM, ATOM 2, LAMP, WA-ATOM, NIH, MOSAIC.
ND10
Efficacy: First solid oral tablet formulation for Myopia control in children. ND10 increases biomechanics strength of the sclera and prevents eye elongation to inhibit progression.
75% reduction in myopia progression.
Drawbacks: None. Compelling safety profile.
Studies: Only phase-3 ready drug for Myopia progression.
6-10 yrs
The ages when the greatest change in refractive error occurs
10%
of all myopic children develop high myopia.
80%
of youth affected by myopia in East and S. East Asia.
52%
Projections suggest that by 2050, nearly half of the global population could be myopic.
41%
Prevalence of High Myopia in children in the United States, and growing.
1. Myopia (Nearsightedness). Available At: https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/myopia?sso=y. Last accessed on 08 May 2024. 2. Data on file. 3. Martínez-Albert N, Bueno-Gimeno I, Gené-Sampedro A. Risk Factors for Myopia: A Review. J Clin Med. 2023 Sep 19;12(18):6062. 4. Rudnicka AR, Owen CG, Nightingale CM, Cook DG, Whincup PH. Ethnic differences in the prevalence of myopia and ocular biometry in 10- and 11-year-old children: the Child Heart and Health Study in England (CHASE). Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6270-6. 5. Biswas S, El Kareh A, Qureshi M, Lee DMX, Sun CH, Lam JSH, Saw SM, Najjar RP. The influence of the environment and lifestyle on myopia. J Physiol Anthropol. 2024 Jan 31;43(1):7. 6. Shah RL, Huang Y, Guggenheim JA, Williams C. Time Outdoors at Specific Ages During Early Childhood and the Risk of Incident Myopia. Invest Ophthalmol Vis Sci. 2017 Feb 1;58(2):1158-1166. 7. Verkicharla PK, Kammari P, Das AV. Myopia progression varies with age and severity of myopia. Plos one. 2020 Nov 20;15(11):e0241759. 8. Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. 9. Banashefski B, Rhee MK, Lema GMC. High Myopia Prevalence across Racial Groups in the United States: A Systematic Scoping Review. J Clin Med. 2023 Apr 21;12(8):3045. 10. Haarman AE, Enthoven CA, Tideman JW, Tedja MS, Verhoeven VJ, Klaver CC. The complications of myopia: a review and meta-analysis. Investigative ophthalmology & visual science. 2020 Apr 9;61(4):49. 11. Trier K, Cui D, Ribel-Madsen S, Guggenheim J. Oral administration of caffeine metabolite 7-methylxanthine is associated with slowed myopia progression in Danish children. British Journal of Ophthalmology. 2023 Oct 1;107(10):1538-44. 12. Lai L, Trier K, Cui DM. Role of 7-methylxanthine in myopia prevention and control: A mini-review. International Journal of Ophthalmology. 2023;16(6):969. 13. https://www.mykidsvision.org/knowledge-centre/when-should-we-start-myopia-control-and-when-should-we-stop . 14. https://www.ncbi.nlm.nih.gov/books/NBK587350/ . 15. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9739333/ 16.Yimin Qin, Chengcheng Lei, Tianfeng Lin, Xiaotong Han, Decai Wang; Identification of Potential Drug Targets for Myopia Through Mendelian Randomization. Invest. Ophthalmol. Vis. Sci. 2024;65(10):13. https://doi.org/10.1167/iovs.65.10.13
ND10 increases the biomechanical strength of the sclera and prevents eye elongation to inhibit myopia progression.
ND10 increases the biochemical strength of the sclera and prevents eye elongation to inhibit myopia progression.
ND10 showed greater clinical efficacy in comparison to optical devices and topical medications over a 3-year period, when comparing published results.
ND10 is the only candidate that meets and crosses the US-FDA minimum threshold, proving clinically meaningful statistical advantage.
Myopic macular degeneration
Myopic macular degeneration (also known as MMD) can occur if you're very short-sighted due to elongation of the eyeball. The stretching of the retina due to the elongation of the eye can result in tears in the macula area. It can also cause bleeding beneath the retina.
Increase in the risk of developing various eye conditions - 102.11x
Retinal Detachment
Retinal detachment describes an emergency situation in which a thin layer of tissue (the retina) at the back of the eye pulls away from the layer of blood vessels that provides it with oxygen and nutrients. Retinal detachment is often accompanied by flashes and floaters in your vision.
Increased risk of development - 3.45x
PERCENTAGE REDUCTION OF MYOPIA PROGRESSION AT 36 MONTHS (DIOPTERS)
ND10 showed greater clinical efficacy in comparison to optical devices & topical medications over a 3-year period, when comparing published results & the the only candidate that meets & crosses the US-FDA minimum threshold, proving clinically meaningful statistical advantage.
First solid oral tablet formulation for Myopia control in children
ND10 increases the biomechanical strength of the sclera and prevents eye elongation to inhibit myopia progression
Only phase-3 ready drug for myopia progression control in development
75% reduction in myopia progression
Compelling safety profile
12 years of clinical usage in Denmark, treated over 1200 children, with nil side effects reported
ABOUT ND10
Posterior subcapsular Cataract
ND10 mechanism of action involves antagonizing adenosine receptors and upregulating dopamine which stimulates the synthesis of collagen I and fibronectin in scleral fibroblasts and thereby increases the scleral collagen content which is often depleted in myopic eyes. This offers a unique way to slow the progression of myopia.
Glaucoma
Glaucoma is a group of eye conditions that damage the optic nerve. The optic nerve sends visual information from your eye to your brain and is vital for good vision. Damage to the optic nerve is often related to high pressure in your eye.
Increased risk of development - 1.95x
TREATMENT OF MYOPIA VS. ND10
PREVALANCE
IMPLICATIONS
Poor quality of life
High lifetime treatment/ management costs
High socio economic costs
High incentive to promote us of preventative therapies
Our solution
Myopia stands out as a significant medical challenge yet to be fully addressed.
In the pursuit of effective myopia management, our novel drug, 7ND10, has demonstrated encouraging outcomes in reducing myopia progression among children.10 Through our research, we have established the safety and tolerability of ND10, underscoring its potential as a promising solution for reducing myopia advancement in the pediatric population.
COMPLICATIONS OF UNTREATED MYOPIA
Myopia is a critical health concern affecting millions worldwide, necessitating a targeted and innovative approach in the development of new treatments. According to an article published by the American Academy of Ophthalmology (AAO) regarding the global prevalence of Myopia, an estimated 1.4 billion people suffer from myopia globally. In the same publication by AAO, prevalence is on the rise and an estimated 4.7 billion or 49.8% of the world population will suffer from myopia. While advancements in current treatments have been initiated, myopia still remains the leading cause of vision impairment globally.
In recent years, there has been a growing concern surrounding the global surge in myopia cases. Research indicates an alarming trajectory: projections suggest that by 2050, nearly half (52%) of the global population could be affected by myopia and around 10% will be highly myopic.
While myopia is becoming prevalent worldwide, certain regions, notably East and Southeast Asia, have emerged as focal points for its heightened prevalence. Countries like South Korea, Taiwan, Singapore, India, and China have reported profound increases in the cases of myopia5. However, it's important to note that myopia in the United States has also witnessed a significant rise in cases, with a prevalence rate of 41%.
ND10 acts primarily on A2A receptors and blocks adenosine release ND10 mechanism of action involves antagonizing adenosine receptors and upregulating dopamine which stimulates the synthesis of collagen I and fibronectin in scleral fibroblasts and thereby increases the scleral collagen content which is often depleted in myopic eyes. This offers a unique way to slow the progression of myopia.
ND10 acts primarily on A2A receptors and blocks adenosine release ND10 mechanism of action involves antagonizing adenosine receptors and upregulating dopamine which stimulates the synthesis of collagen I and fibronectin in scleral fibroblasts and thereby increases the scleral collagen content which is often depleted in myopic eyes. This offers a unique way to slow the progression of myopia.
ND10 acts primarily on A2A receptors and blocks adenosine release ND10 mechanism of action involves antagonizing adenosine receptors and upregulating dopamine which stimulates the synthesis of collagen I and fibronectin in scleral fibroblasts and thereby increases the scleral collagen content which is often depleted in myopic eyes. This offers a unique way to slow the progression of myopia.
ND10 acts primarily on A2A receptors and blocks adenosine release ND10 mechanism of action involves antagonizing adenosine receptors and upregulating dopamine which stimulates the synthesis of collagen I and fibronectin in scleral fibroblasts and thereby increases the scleral collagen content which is often depleted in myopic eyes. This offers a unique way to slow the progression of myopia.
ND10 acts primarily on A2A receptors and blocks adenosine release ND10 mechanism of action involves antagonizing adenosine receptors and upregulating dopamine which stimulates the synthesis of collagen I and fibronectin in scleral fibroblasts and thereby increases the scleral collagen content which is often depleted in myopic eyes. This offers a unique way to slow the progression of myopia.
Understanding Myopia
Myopia, also commonly referred to as ‘near-sightedness’ or ‘short-sightedness’, is a common eye condition that causes blurred distance vision. In individuals with myopia, the eyeball is either elongated or the cornea is excessively curved, making distant images appear blurry. This condition is influenced by both genetic factors and environmental influences such as prolonged near activities, family history of myopia, ethnicity, and higher levels of education. Failure to address this issue can lead to progressive deterioration of a child’s vision as they get older. Consequently, this results in vision impairment among children. In myopic eyes, the eyeball is either longer than normal, causing the image to be blurry.