In the rapidly evolving landscape of medical treatments, innovations often surface that possess the potential to fundamentally alter existing paradigms. One such breakthrough is the use of atropine drops in managing child myopia. While atropine, a medication traditionally used to dilate the pupil and treat certain eye conditions, may not seem revolutionary at first glance, its application in myopia control is poised to become a game-changer across Europe, particularly with the strategic involvement of companies like Santen.

Based on our analysis, we estimate the potential market for atropine drops in Europe could reach up to €500 million within the next 5 to 10 years. This projection is grounded in the increasing prevalence of myopia, the demonstrated effectiveness of atropine drops in clinical trials, and the anticipated regulatory approvals and market adoption

The Myopia Epidemic

Myopia, or near-sightedness, is a growing concern worldwide, with the World Health Organization (WHO) estimating that half of the global population could be myopic by 2050. Europe is no exception, with a notable increase in the prevalence of myopia among children. Each year, approximately 5 million new cases of myopia are diagnosed in children across Europe, with the average age of diagnosis being around 8 years old. The rising incidence of myopia is alarming, given its association with severe ocular complications later in life, such as retinal detachment, glaucoma, and macular degeneration¹.

Traditionally, myopia management has focused on corrective measures like glasses and contact lenses. However, these solutions do not address the progression of the condition.

Enter atropine drops, an intervention that not only corrects but also slows the progression of myopia.

How Atropine Drops Work

Atropine is an antimuscarinic agent that works by inhibiting the growth of the eye, thereby reducing the elongation of the eyeball which causes myopia. Clinical studies have shown that low concentrations of atropine (0.01%-0.05%) are effective in significantly slowing myopia progression in children, with minimal side effects².

The mechanism behind atropine's effectiveness in myopia control is not fully understood, but it is believed to involve the modulation of certain biochemical pathways in the eye. This innovative use of an old drug represents a classic case of repurposing existing medications to address new challenges.

Santen’s Role and Success in Asia

A key player in the advancement and potential widespread adoption of atropine drops in Europe is Santen, a company with a proven track record in ocular health solutions. Santen has already demonstrated significant success in Asia, particularly in Taiwan, where the implementation of atropine drops for myopia management has yielded impressive results.

“Seeing the positive impact of atropine drops on children's vision in Taiwan has been incredibly rewarding. We believe this success can be replicated in Europe, addressing a growing public health concern”, says Dr Li Wei, CEO of Santen³.

In Taiwan, Santen's efforts have led to widespread acceptance and use of low-dose atropine drops among children. Studies and practical applications have shown a marked decrease in the progression of myopia, with minimal side effects. This success story not only highlights the efficacy of atropine drops but also highlights Santen's ability to navigate regulatory environments, engage with healthcare providers, and educate the public on new treatments.

Taiwanese parents have expressed their satisfaction and relief on various forums. One parent shared, “Atropine drops have made a huge difference for my son. His myopia progression has slowed down significantly, and he has not experienced any side effects. It is a game-changer for us”⁴.

In 2021, Santen and Sydnexis executed an exclusive licensing agreement for SYD-101, a novel atropine formulation for myopia control, further enhancing Santen's commitment to addressing myopia on a global scale⁵.

Santen’s expertise and experience in Taiwan provide a robust foundation for introducing atropine drops in Europe. The company’s strategic initiatives include:

• Regulatory Navigation: Leveraging their experience in Taiwan, Santen is well-equipped to manage the rigorous clinical trials and safety evaluations required by European regulatory bodies such as the European Medicines Agency (EMA).
• Public Awareness Campaigns: Santen plans to implement comprehensive education campaigns to inform parents and healthcare providers about the benefits and safety of atropine drops, mirroring their successful approach in Asia.
• Public Awareness Campaigns: Santen plans to implement comprehensive education campaigns to inform parents and healthcare providers about the benefits and safety of atropine drops, mirroring their successful approach in Asia.

Santen’s Strategy and Clinical Trials

Santen has a robust strategy for addressing myopia with atropine drops in Europe, underpinned by ongoing clinical trials and strategic collaborations. According to Santen’s 2022 annual report, the company is actively involved in several initiatives to advance the development and commercialization of low-dose atropine drops⁶.

• Clinical Trials: Santen has initiated multiple clinical trials across Europe to validate the efficacy and safety of atropine drops in controlling myopia progression. These trials are critical for gaining regulatory approval and ensuring that the treatment meets the stringent standards required in the European market. The current trials are in Phase III, involving thousands of participants across multiple European countries, with expected completion in late 2024⁶.
• Strategic Collaborations: Santen collaborates with leading research institutions, including the Singapore Eye Research Institute (SERI) and University College London (UCL), to leverage innovative research and innovation in ophthalmology. These partnerships enhance Santen's capabilities in developing effective myopia treatments⁶.

Other Technologies and Stakeholders in the Myopia Treatment Market

Beyond Santen, several other key stakeholders are actively involved in the myopia treatment market, focusing on alternative solutions to prevent further myopia development in children and even improve the condition:

• Novartis: A major pharmaceutical company, Novartis has invested in myopia control through its innovative lens technologies and ongoing research into pharmacological treatments. Novartis is developing contact lenses that incorporate myopia control technologies to manage the progression of the condition.
• CooperVision: Known for its contact lenses, CooperVision has developed MiSight 1 day, the first FDA-approved contact lens designed to slow myopia progression in children. These lenses have been clinically proven to reduce the progression of myopia by about 59% over three years.
• EssilorLuxottica: A global leader in eyewear, EssilorLuxottica is actively developing and marketing lenses designed to manage myopia progression. Their innovative lens technologies, such as the Myopilux range, aim to reduce eye strain and slow the progression of myopia in children.
• Zeiss: Another major player in the optical industry, Zeiss offers myopia control solutions through specialized lenses and ongoing research in myopia management. Zeiss MyoVision lenses are designed to reduce peripheral hyperopic defocus, which is believed to contribute to myopia progression.

Who Will Win: Atropine Drops vs. Corrective Lenses?

In the competition between atropine drops and corrective lenses, both approaches have unique advantages and potential limitations. Atropine drops offer a pharmacological solution that addresses the root cause of myopia progression by inhibiting the elongation of the eyeball. Clinical evidence supports their effectiveness in significantly slowing down myopia progression with minimal side effects. Additionally, the convenience of a daily drop regimen appeals to many parents and children who might find it easier to incorporate into their daily routines compared to managing contact lenses.

Corrective lenses, such as those developed by Novartis, CooperVision, EssilorLuxottica, and Zeiss, provide a non-invasive option that can be immediately integrated into a child's existing vision correction regimen. These lenses not only correct vision but also incorporate technologies to reduce the progression of myopia. The lenses are particularly advantageous for children who might struggle with the daily administration of eye drops.

Market Dynamics and Traction

While both atropine drops and corrective lenses will find their place in the market, atropine drops are likely to gain more traction in the short term due to their demonstrated efficacy in clinical trials and the growing body of evidence supporting their use. Parents seeking an effective and straightforward solution may gravitate towards atropine drops. However, corrective lenses will continue to play a significant role, particularly for children who prefer or require non-pharmacological interventions.

Ultimately, a combination of both approaches may offer the most comprehensive strategy for managing myopia in children. By leveraging the strengths of pharmacological treatments like atropine drops and innovative corrective lenses, healthcare providers can tailor interventions to meet the specific needs of each child.

Disruption in the Market

The adoption of atropine drops for child myopia in Europe could disrupt the traditional market in several ways:

• Shift from Corrective to Preventive Care: The use of atropine drops marks a significant shift from merely correcting myopia to preventing its progression. This paradigm shift is likely to reduce the long-term dependence on corrective lenses and could lead to a decrease in the demand for glasses and contact lenses.
• Healthcare Cost Savings: By preventing the progression of myopia, atropine drops can potentially reduce the incidence of high myopia and its associated complications. This could lead to substantial savings in healthcare costs related to the treatment of severe ocular diseases.
• Regulatory and Clinical Landscape: The regulatory approval and widespread clinical adoption of atropine drops in Europe could set new standards for myopia management. This may prompt further research and development in pharmacological treatments for myopia, fostering innovation in the field.

Challenges and Considerations

Despite its promise, the widespread adoption of atropine drops faces several challenges:

• Regulatory Hurdles: Gaining approval from European regulatory bodies involves rigorous clinical trials and safety evaluations. The approval process can be lengthy and complex⁷.
• Public Awareness and Acceptance: Educating parents and healthcare providers about the benefits and safety of atropine drops is crucial. Overcoming scepticism and ensuring acceptance will require concerted efforts from medical professionals and public health campaigns.
• Long-Term Safety: While short-term studies have shown minimal side effects, the long-term safety of low-dose atropine treatment needs continuous monitoring. Ensuring that the treatment does not lead to unforeseen complications is essential for its sustained use⁸.

How We Can Help

At S&S, a market research and strategy consulting agency, we specialize in navigating the potential disruptive effects of new treatments like atropine drops on the current market for child myopia. We provide comprehensive market research and strategic insights to help companies in the ophthalmology sector adapt to these changes.

Market Research Services

Sector & Segment provides tailored research and analysis of the myopia treatment market and related patient journeys. Our experts can investigate the competitive landscape and provide insights on medical pathways to help you refine your go-to-market strategy. We have easy access to over 100 ophthalmologists treating children in core European countries.

• Patient/Caregiver and HCP Insights: We gather and analyse insights to understand the perceptions, preferences, and behaviours of parents, patients, and healthcare providers regarding myopia treatments.
• Competitor Analysis: Our comprehensive competitor analysis helps companies understand the competitive landscape and identify opportunities for differentiation.
• Market Opportunity Analysis: We size and quantify the market opportunity, analyse the market landscape, and uncover avenues for differentiation.
• Patient and HCP Profiling: We identify patient needs and pain points, profile and segment relevant patients and HCPs.
• Engagement Strategies: We design engaging strategies for HCPs to enhance their awareness of ophthalmological concerns and optimize patient outreach.

For further assistance and information, please do not hesitate to contact us at info@sectorandsegment.com.

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