Key Takeaways
- First and only daily disposable lens for multifocal astigmatism: Acuvue Oasys Max 1-Day Multifocal for Astigmatism is the first lens designed to correct both presbyopia and astigmatism in a daily disposable format.
- FDA-cleared with strong performance data: The lens received FDA 510(k) clearance in 2021 based on non-clinical and clinical data showing 95% of users reported clear vision and 92% experienced all-day comfort.
- Addresses major unmet vision care need: With up to 62% global prevalence of astigmatism and rising rates of presbyopia, the new lens meets a critical demand for dual-condition correction in aging adults.
Johnson & Johnson (J&J) has announced the launch of the Acuvue Oasys Max 1-Day Multifocal for Astigmatism, marking the first and only daily disposable contact lens designed specifically for individuals with both astigmatism and presbyopia. According to the company, the new lens provides clear, stable vision across all distances and lighting conditions, as well as all-day comfort that is supported by four proprietary technologies: Blink Stabilized, Pupil Optimized, TearStable, and the OptiBlue Light Filter.1
How Does this New Lens Address a Major Unmet Need in Vision Care?
“Building on our legacy of firsts, we are thrilled to launch Acuvue Oasys Max 1-Day Multifocal for Astigmatism,” said Peter Menziuso, company group chairman, vision, J&J, in a press release. “Acuvue is the world’s leading contact lens brand and with these new products, we now have the first and only complete family of daily-disposable contact lenses. #1 Clear sight empowers people to live their best lives, and we believe everyone should have the opportunity to achieve it. That’s why we focus our innovation on areas with the greatest unmet needs for patients. Today, we are working to fulfill that promise, providing millions of patients with a differentiated Acuvue experience.”
FDA Clearance Supported by Equivalence and Performance Data
The Acuvue Oasys Max 1-Day Multifocal for Astigmatism was first granted FDA 510(k) clearance in November 2021 based on a combination of clinical and non-clinical data. The submission demonstrated that the new lens was substantially equivalent to predicate and reference devices through extensive non‑clinical testing—covering material, optical, and physicochemical comparisons—thus negating the need for dedicated clinical trials under the FDA’s 1994 guidance on daily‑wear lenses. Additional clinical data demonstrated that 95% of users reported clear vision during daily activities, 87% reported clear vision at night, and 92% experienced all-day comfort.1,2
Prevalence and Impact of Astigmatism and Presbyopia
According to J&J, astigmatism affects approximately 50% of the global population, making it one of the most common vision issues worldwide. A review of 125 previous studies published in the National Center for Biotechnology Information found that the overall prevalence of astigmatism ranges from 8% to 62% depending on age, with the highest rates observed in individuals aged 70 years and older.
With-the-rule astigmatism was more common in people under 40 years of age, while against-the-rule and oblique astigmatism were more prevalent in older adults. The study also found that the condition resulted in a 45% to 85% rate of spectacle dependence and increased fall risk.3
According to the American Optometric Association, approximately 90% of people in the United States over the age of 45 years are affected by presbyopia.4 In 2015, it impacted an estimated 1.8 billion people globally, with the prevalence projected to rise to around 3.1 billion by 2030.5
Launch Timeline and Future Expansion
The Acuvue Oasys Max 1-Day Multifocal for Astigmatism is expected to launch in the United States and Canada later this summer. The product line will also expand with the release of the toric version for astigmatism alone, with additional international markets expected to follow in 2025 and beyond.1
“Finally, patients with both presbyopia and astigmatism can enjoy the freedom and comfort of a daily disposable lens without compromising the quality of their vision,” Mark Wells, OD, in the press release, “This new lens was designed to help patients who struggle with multiple vision correction issues, allowing them to experience the comfort and clarity of Max.”
References
1.Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens1 - ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM. J&J. Accessed June 23, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-launches-first-and-only-daily-disposable-multifocal-toric-contact-lens1-acuvue-oasys-max-1-day-multifocal-for-astigmatism
2. FDA Letter to J&J. FDA. November 21, 2021. Accessed June 23, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210930.pdf?utm_source=chatgpt.com
3. Epidemiology and Burden of Astigmatism: A Systematic Literature Review. NIH. Accessed June 23, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC10045990/?utm_source=chatgpt.com
4. For 128 million U.S. presbyopes, doctors of optometry can provide treatment options. AOA. Accessed June 23, 2025. https://www.aoa.org/news/clinical-eye-care/diseases-and-conditions/for-128-million-us-presbyopes-doctors-of-optometry-can-provide-treatment-options
5. BCLA CLEAR Presbyopia: Epidemiology and impact. ScienceDirect. Accessed June 23, 2025. https://www.sciencedirect.com/science/article/pii/S1367048424000493#:~:text=The%20global%20all%2Dages%20prevalence%20of%20epidemiologically%2Dmeasured%20functional%20presbyopia,%2C%202.2%20%E2%80%93%202.4%20billion).
