A panel of leading clinicians, researchers, and industry voices tackled the challenges and opportunities shaping the myopia treatment landscape, highlighting both promising innovations and the hurdles still ahead. While the panelists hailed from multiple countries and sectors, their shared goal was clear – slowing myopia progression in children and adolescents, while balancing efficacy, safety, and practicality.
Why myopia matters
For decades, myopia was considered a simple refractive issue correctable with glasses or contact lenses. Today, its growing prevalence and potential to cause serious visual impairment have made it a pressing public health concern, explained Dr. Mark Bullimore, panel co-chair.
“We have a better understanding of the role that it plays in uncorrectable visual impairment, and the fact that we have [the] ability now to delay it and slow its progression,” said Bullimore, who heads 7,000 Feet, a Colorado-based company providing expert guidance to ophthalmic companies on planning, execution and interpretation of clinical studies as part of FDA processes.
Regulatory hurdles: a global perspective
While early treatment shows promise in reducing long-term risks of myopia, turning effective therapies into accessible options isn’t always straightforward – global regulatory standards vary widely, making broad market approval a complex challenge.
In China, for example, myopia control spectacles launched in 2020 without being classified as medical devices, allowing faster access for patients, said panelist Olga Prenat, Global Head of Medical & Professional Affairs at EssilorLuxottica and Chair of the Global Myopia Awareness Coalition (GMAC).
In contrast, FDA classification of myopia-control spectacles and soft contact lenses in the US require rigorous pre-market approval demonstrating both safety and efficacy before they are available to patients.
“It may surprise you that the FDA has classified myopia control spectacles and myopia control soft lenses as class III devices,” said Bullimore. “So, they have to go through the PMA (premarket Approval) route and demonstrate reasonable assurance of safety and efficacy.”
These differences create significant challenges for companies seeking to distribute products internationally. Navigating these regulatory pathways is both expensive and time-consuming, yet also essential for patient safety and product credibility.
Despite these regulatory complexities, industry leaders remain undeterred. Companies are pushing forward with innovation, underscoring their commitment to advancing safe and effective options for myopia management.
Industry efforts and pipeline updates
At the Forum, major players such as Alcon and Bausch+Lomb outlined their approaches to myopia management. While proprietary details were limited, panelists highlighted their strong commitment to research and development.
"By 2050 you’re going to have 5 billion people [with myopia],” said panelist Dr. Terry Kim, Chief Medical Officer and Head of Global Medical Safety at Alcon. “The more concerning part is 10% of those who are going to be high myopic.”
Recent launches of specialized contact lenses and lens technologies, combined with ongoing trials in Europe, China, and the US, aim to provide robust long-term data on treatment outcomes. Such data underscores the potential for early interventions to meaningfully reduce the risk of high myopia and related complications later in life.
Ethical considerations in clinical trials
One of the most hotly debated topics was the ethics of untreated control groups in clinical trials, particularly studies lasting three years or longer. Panelists agreed that withholding treatment from children at risk of progressive myopia raises serious ethical concerns.
“First, I think it’s unethical because it’s a condition that progresses in most of them if not treated, so it is unfair,” noted panelist Dr. Annegret Dahlmann-Noor, a consultant ophthalmologist specializing in pediatric eye health at Moorfields Eye Hospital in London.
Practical challenges further complicate these trials – parents often withdraw children to seek treatment elsewhere if their myopia progresses faster than expected, making data collection and analysis difficult.
“If you look at clinical trials, out of the 40 trials ongoing for myopia progression 70% of them have a control group with a sham or no treatment. So that's tough not only in terms of retention but also recruitment” said Kim.
Several panelists suggested innovative trial designs to address these challenges.
“Some regulators still don’t see the perspective, but we do believe that through some of the new clinical trial designs we can achieve a better approach for these patients,” said panelist Dr. Yehia Hashad, Executive Vice President of Research & Development and Chief Medical Officer at Bausch + Lomb. Approaches such as crossover studies, interim analyses, and comparisons with existing treatments could maintain scientific rigor while ensuring patient safety and engagement.
Choosing meaningful endpoints
Building on the ethical and practical considerations of trial design, panelists emphasized that selecting meaningful endpoints is crucial. Accurately measuring the impact of interventions ensures studies generate reliable data while reflecting outcomes that matter to both patients and clinicians.
Panelists debated the merits of measuring refractive error in diopters versus axial length. “The goal should be to prevent pathologic myopia – that is most strongly correlated with axial length,” said Dr. Steve Schallhorn, Chief Medical Officerat Carl Zeiss Meditec and clinical professor of ophthalmology at the University of California, San Francisco. “If anything, it’s got to be axial length, and there have got to be some criteria.”
Axial length is closely linked to the risk of future complications, making it a more predictive measure than refractive error alone. Importantly, parents and children can understand this concept when it’s explained clearly. “Once you explain the simple fact that progressive myopia is usually caused by the eyeball getting longer, they are perfectly able to switch from diopters to millimeters,” said Dahlmann-Noor.
Still, access to biometry devices is not universal, making refractive error the more feasible measure in routine clinical practice. Panelists emphasized that endpoints should balance scientific rigor with real-world applicability.
Patient-centered outcomes
Beyond clinical measures, the panel highlighted the importance of patient-centered outcomes, such as treatment adherence, satisfaction, and quality of life.
Dahlmann-Noor emphasized that parents care about more than just clinical results. “Additional outcomes that came through very strongly are things like satisfaction with the treatment, which is not always reported [but] may be reflected in adherence or compliance,” she said. In the UK, where families pay out of pocket, parents especially want to know “How many kids actually use this treatment that you are asking me to pay for?”
Quality of life is not just vision-related, but also refers to the impact of glasses or contact lenses on school activities and how they play a major role in adherence and daily functioning. Collecting data on these real-world impacts can provide valuable insights into treatment effectiveness beyond clinical measures.
Understanding these outcomes naturally leads to a consideration of what happens when treatment ends. Just as adherence, satisfaction, and daily functioning influence real-world effectiveness, so too does the potential for rebound, highlighting the importance of trial designs that reflect actual treatment patterns.
Rebound – accelerated myopia progression after stopping treatment – was another key topic covered by the panel.
In research, an artifact refers to a result that looks like a true effect but is actually caused by how a study is designed or conducted. Dahlmann-Noor suggested that the so-called rebound effect after stopping myopia treatment may fall into this category. “I struggle with rebound because I think it’s an artifact,” she said. “We know it is inversely correlated with the age of the person in whom you are stopping the treatment. I think there is the fallacy, because when we run clinical trials we try to enroll the younger ones because we know or anticipate it will have a bigger treatment effect. When we stop treatment in under-10-year-olds after just two or three years, of course progression continues.”
Rebound effects are less pronounced when treatment is discontinued at older ages. Panelists suggested that clinical trials should reflect real-world treatment patterns to yield meaningful data on rebound risk.
Collaboration and regulatory alignment
Collaboration between clinicians, industry, regulators, and patients is essential for advancing myopia management. Panelists emphasized that multi-stakeholder engagement can improve trial design and ensure treatments meet both scientific and patient needs. Public and patient involvement, particularly through advisory groups, was highlighted as a critical component of trial planning. Young people trained in research processes can provide informed feedback on trial design and treatment priorities.
International insights
Panelists shared their experiences from school-based myopia programs in China, which have demonstrated measurable reductions in progression through vision screening, outdoor activity promotion, and lifestyle interventions. Such real-world interventions complement clinical strategies and highlight the potential impact of preventive programs at the population level.
Conclusion
The panel underscored the complexity of addressing myopia progression. Scientific, regulatory, ethical, and practical considerations must all be balanced to develop effective interventions. While challenges remain – particularly regarding trial design and global regulatory alignment – ongoing research, innovative treatment approaches, and multi-stakeholder collaboration offer promising pathways forward.
As myopia prevalence continues to rise worldwide, the insights shared by this panel highlight the critical importance of evidence-based strategies, patient engagement, and long-term planning to preserve vision and improve quality of life for children at risk of high myopia.
Key Takeaways
From the discussion, several consensus points emerged:
Axial length is the most meaningful clinical endpoint for predicting long-term risk.
Ethical trial design is essential, particularly regarding untreated control groups.
Patient-centered outcomes – including adherence, satisfaction, and quality of life – are critical to understanding treatment success.
Global regulatory requirements vary, requiring careful planning for multi-region product approvals.
Rebound effects should be monitored, especially for pharmacological interventions.
Collaboration among all stakeholders is key to advancing safe and effective myopia management.
You can sign up for next year’s Ophthalmology Futures European Forum meeting, taking place on September 10th 2026 in London, here: https://www.ophthalmology-futures.com/.
