West China Hospital Leads Landmark 3,061-Case Multicenter Study Validating Domestic Defocus Lenses for Myopia Control

A landmark 12-month prospective multicenter clinical study published in BMC Ophthalmology has provided the largest real-world evidence to date for defocus lenses in myopia control among Chinese children and adolescents. The research, led by West China Hospital of Sichuan University and conducted across multiple ophthalmology centers nationwide, enrolled 3,061 participants with myopia ranging from -0.50D to -10.00D and astigmatism of ≤4.00D.

The study demonstrated that children wearing Publens M-series defocus lenses, manufactured by Eyebright Medical (688050.SH), showed a 0.49D reduction in myopia progression and a 0.21mm reduction in axial length elongation compared to those wearing single-vision control lenses over the 12-month period. Younger participants and those with lower baseline myopia experienced relatively greater treatment benefits.

The prospective, multicenter, non-randomized, controlled, single-blind (evaluator-masked) design employed propensity score matching (PSM) to control for confounding bias. Participants were allocated in a 2:1 ratio based on personal or parental choice: 1,952 wore multifocal defocus lenses (AMD group) while 1,109 wore single-vision lenses (SV group). Researchers assessed annual changes in spherical equivalent refraction (SER) measured after cycloplegia and axial length (AL) using automated refraction.

At the 12-month follow-up, 1,367 participants (875 in the AMD group, 492 in the SV group) completed cycloplegic SER measurements, while 1,791 participants (1,194 in the AMD group, 597 in the SV group) completed AL measurements. After propensity score matching, the AMD group showed significantly less myopic progression compared to the SV group (-0.30±0.24D vs. -0.79±0.34D, P<0.001). Similarly, axial length elongation was significantly slower in the AMD group (0.18±0.12 mm vs. 0.39±0.17 mm, P<0.001).

The defocus lenses demonstrated efficacy rates of 62.0% in slowing myopia progression and 53.8% in reducing axial length elongation. However, the study observed an interaction effect between age and treatment group, with the lenses' effectiveness diminishing as age and baseline SER increased. While the non-randomized design limits causal inference despite PSM adjustment, the 3,061-case sample size provides strong representativeness for real-world clinical practice, though subgroup analysis capabilities and external validity differ from randomized controlled trials (RCTs).

The defocus lens market currently features two primary technological approaches: annular microstructure design and bionic compound-eye multi-point defocus design. The annular microstructure approach employs 360° closed defocus ring structures with multiple defocus options ranging from +4.50D to +5.50D, accommodating different refractive error ranges. The bionic compound-eye approach uses hexagonal microlens arrays, increasing defocus fill rates through higher microlens density. Both designs incorporate high-order aspheric surfaces combined with freeform surfaces to ensure smooth refractive power transitions, though differences in visual quality, adaptability, and long-term safety require head-to-head comparative studies.

Eyebright Medical's Publens series product iteration reflects the evolution of domestic defocus lenses in microlens density and optical zone design. In October 2021, the company launched a bionic compound-eye multifocal defocus lens using hexagonal microstructure technology. In November 2023, it introduced the M-series annular microstructure defocus lens with three defocus options (+4.50D to +5.50D). In April 2024, the B-series bionic compound-eye defocus lens debuted with 834 defocus microlenses per lens and a 75% defocus area. Most recently, in November 2025, the B Plus bionic compound-eye defocus lens increased microlens count to 1,038, featuring a 7mm optical zone, 75% defocus fill rate, and a 30% increase in defocus area compared to its predecessor. However, these technical specifications represent manufacturer-provided design metrics, and their direct correlation with clinical myopia control efficacy currently lacks publicly available RCT validation.

China's defocus lens market is experiencing rapid expansion. According to Frost & Sullivan data, the retail market for adolescent myopia management defocus lenses reached approximately RMB 14.68 billion (USD 2.03 billion) in 2023 and is projected to reach RMB 47.76 billion (USD 6.61 billion) by 2028. National Disease Control Bureau surveillance data from 2022 indicates that China's overall myopia rate among children and adolescents stands at 51.9%, with rates of 36.7% among primary school students, 71.4% among middle school students, and 81.2% among high school students.

The market presents a landscape of "foreign brands dominating the high-end segment while domestic brands accelerate their rise." International players including EssilorLuxottica, ZEISS, and HOYA leverage first-mover advantages, mature microlens technology, and brand influence to maintain market dominance. Domestic brands such as Mingyue Lens, Wanxin Optics, Huiding Optics, and Eyebright Medical are rapidly capturing mid-market share through cost-effectiveness, localized technology, and flexible channel strategies. Some smaller brands and private-label products rely primarily on low-price competition without clinical data support. As industry regulation tightens and the 2025 Expert Consensus on Multi-Point Microlens Myopic Defocus Design Lenses takes effect, brands lacking evidence-based foundations will face market exit pressure.

At the policy level, the National Health Commission's 2024 Myopia Prevention and Control Guidelines have incorporated specially designed defocus spectacle lenses as a recommended intervention option for children and adolescents, alongside orthokeratology lenses and low-concentration atropine, forming a diversified toolkit for myopia management. Defocus spectacle lenses, with their relatively lower barriers and simpler fitting processes, serve as an intermediate option between orthokeratology lenses and conventional single-vision lenses.

Listed company data directly corroborates this trend. In the first quarter of 2025, Mingyue Lens's "Easy Control" series achieved sales of RMB 50.13 million (USD 6.94 million), representing a 22.1% year-over-year increase. First-half sales reached RMB 81.67 million (USD 11.31 million), up 7.32% year-over-year. Cumulative sales for the first three quarters totaled RMB 132 million (USD 18.28 million), an 8.5% year-over-year increase, with third-quarter sales alone reaching approximately RMB 50.80 million (USD 7.03 million), up 10.5% year-over-year.

In September 2025, the FDA authorized the market entry of Essilor's Stellest through the De Novo pathway, marking the first myopia control spectacle approved in the United States. This regulatory pathway itself reflects the U.S. regulatory system's repositioning of myopia control spectacles. For the Chinese market, the core competitive barrier going forward will increasingly derive from evidence systems rather than product specifications alone.

The myopia prevention and control sector is undergoing three fundamental transformations. First, consumer products are gradually acquiring medical device attributes. Second, single-product competition is giving way to solution-based competition. Third, product iteration speed continues to accelerate, with companies like Eyebright Medical and Ophthalmlux rapidly expanding cross-category product portfolios. For Publens, key questions remain: whether long-term follow-up data can sustain the 12-month efficacy, whether different product lines can achieve complementarity, and whether channel capabilities and brand recognition can support clinical accessibility in the consumer medical market. The core to domestic defocus lenses breaking the foreign-dominated landscape may lie in closing the evidence gap at the RCT level.