The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb’s enVista Envy full range of vision intraocular lens (IOL).
According to the eye healthcare giant in a press release announcing the approval, the lens offers a “continuous range of vision with excellent dysphotopsia tolerance on the widely used enVista IOL platform.” Dysphotopsia includes things like halos, glares and starbursts.
An IOL is an artificial lens implanted in the eye to replace the natural lens that has become cloudy due to a cataract.
The enVista Envy IOL is designed to offer clear vision at near, intermediate and far distances due to astigmatism, reducing the need for patients to wear corrective lenses post-surgery.
The lens incorporates the company’s ActivSync Optic intelligent energy distribution technology to optimize vision across various lighting conditions.
Cataracts affect millions of people globally and are a major cause of vision impairment, especially among older adults.
Cataract surgery, which involves replacing the cloudy lens with an artificial IOL, is a highly successful procedure to restore clear vision. However, traditional IOLs may not always provide a full range of vision, often requiring patients to rely on glasses for specific tasks, such as reading or seeing objects at intermediate distances.
The enVista Envy IOL aims to address this limitation by offering a full range of vision, from near to distance. The advanced optics of the lens are designed to minimize visual disturbances such as halos and glare, which are common side effects of multifocal IOLs.
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Envy allows surgeons to treat a broader range of astigmatic patients with enhanced precision and accuracy, featuring adjustments in 0.5D increments (or smaller) throughout the cylinder range.
Positive long-term outcomes of the enVista Envy IOL were demonstrated in a multicenter US trial involving 332 participants. On average, 86 percent of patients reported experiencing minimal to no bothersome symptoms related to dysphotopsia (such as glare, halos and starbursts), highlighting an excellent tolerance profile.
Similarly, in a clinical study in Canada with 110 participants, 94 percent reported little to no difficulty in viewing close objects, and 93 percent expressed moderate to complete satisfaction with their post-surgery vision.
The IOL was approved in Canada in May.
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The enVista Envy IOL is made from an advanced hydrophobic acrylic material, which ensures easy handling and a smooth insertion process during surgery. The design also incorporates aspheric optics to enhance contrast sensitivity, offering improved image quality under a variety of lighting conditions.
With an aging population driving demand for cataract surgeries, the market for premium IOLs that can deliver better visual outcomes is expected to grow substantially.
The global IOL market was valued at $4.47 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 4.63 percent from 2024 to 2030. Key factors driving this growth include the rising diabetic population, technological advancements, increasing demand for multifocal IOLs, the benefits of acrylic materials, a surge in cataract surgeries and the rapidly aging global population.
The prevalence of vision impairment is rising globally. According to the World Health Organization (WHO), approximately 2.2 billion people are affected by vision impairment, with at least 1 billion cases that could have been prevented or remain unaddressed.
The leading causes of distance vision impairment or blindness worldwide include cataracts (94 million), age-related macular degeneration (8 million), glaucoma (7.7 million) and diabetic retinopathy (3.9 million).
This increasing burden of eye diseases is a key market driver, as these conditions often require surgical interventions like cataract removal and lens replacement. Such procedures not only restore vision lost to cataracts but also correct refractive errors, including myopia, hyperopia, astigmatism and presbyopia.
Bausch + Lomb said the enVista Envy IOLs will be available on a limited basis in the US in the coming weeks, with broader availability planned for 2025. The company is also actively pursuing regulatory approvals for the lens in additional international markets.
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