Bausch + Lomb Launches Arise™ Orthokeratology Lens System in the United States
Bausch + Lomb Corporation (NYSE/TSX:BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the U.S. launch of Arise, a lens fitting system that uses intelligent, cloud-based technology to streamline the orthokeratology lens design process. Arise seamlessly syncs directly with topographers – diagnostic tools that capture 3-D images of the eye – to create precise lens designs in seconds to treat myopia. These lenses include the first orthokeratology lens design with toric peripheral curves* approved by the U.S. Food and Drug Administration to treat myopia overnight.
Myopia, or nearsightedness, is one of the most common ocular disorders worldwide and a leading cause of visual impairment in children.1 Studies predict the global prevalence of myopia will rise from 28% of the world's population (two billion people) in 2010 to 50% of the world's population (five billion people) by 2050.2
"Traditional orthokeratology lens fitting methods can be complex and time-consuming," said Yang Yang, president, Global Vision Care, Bausch + Lomb. "The Arise platform's streamlined fitting process will reduce chair time† and increase efficiency for eye care professionals."
Engineered for precision and speed, Arise uses advanced algorithms to instantly interpret corneal topography images and recommend lens designs in seconds – no fitting set required. It is designed for lens fitters of all experience levels and efficiently evaluates lens centration and patient progress using its overnight outcome map library, recommending adjustments following overnight wear, if needed. Additionally, the cloud-based platform allows secure access to patient data from anywhere and direct support from the Bausch + Lomb expert consultation team.
"Arise combines all aspects of the orthokeratology process—from topography capture to lens design and more—into one seamless, user-friendly technology," said Brooke Messer, OD, FAAO, FSLS, Vance Thompson Vision, West Fargo, North Dakota. "The ease and precision of Arise will be a welcome addition to my practice."
Arise is now commercially available in the United States, the United Kingdom and Europe.
*Based on clinical study data
INDICATIONS FOR USE
Boston Orthokeratology (oprifocon A) shaping lenses for overnight wear are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear as part of the Bausch + Lomb Vision Shaping Treatment VST® process for the temporary reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system.
SAFETY INFORMATION CONTRAINDICATIONS
DO NOT USE the Boston Orthokeratology (oprifocon A) shaping lenses when any of the following conditions exist:
- Acute and sub-acute inflammations or infection of the anterior chamber of the eye
- Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids
- Severe insufficiency of tears (dry eyes)
- Corneal hypoesthesia (reduced corneal sensitivity)
- Any systemic disease which may affect the eye or be exacerbated by wearing contact lenses
- Allergic reactions of ocular surfaces or adnexa which may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
- Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care for your Boston Orthokeratology (oprifocon A) shaping lenses
- Any active corneal infection (bacterial, fungal, or viral)
- If eyes become red or irritated
WARNINGS
The risk of ulcerative keratitis has been shown to be greater among wearers of extended wear lenses than among wearers of daily wear lenses. The risk among extended wear use users increases the number of consecutive days that lenses are worn between removals, beginning with the first overnight use. Smoking increases the risk of ulcerative keratitis for contact lens wearers. Wearing the lenses continuously (extended wear) presents increased risk, which increases with the number of consecutive days the lenses are worn between removals. Although the safety risks of overnight wear with removal upon wakening may not be as great as with extended wear, there is still increased risk beginning with the first overnight period.
PRECAUTIONS
When selecting an appropriate lens design and parameters, the eye care practitioner should consider all factors that affect lens performance and the patient's ocular health; including oxygen permeability, wettability, central and peripheral thickness, and optic zone diameter.
ADVERSE EVENTS
A total of 378 eyes (191 patients) were enrolled in a clinical study. There were twelve significant lens-related adverse events reported in ten subjects. All eyes that showed acuity reductions were documented as returning to normal vision, except two eyes of one subject with severe corneal staining that showed ≥2 lines loss of BSCVA. The return to pre-treatment VA was not recorded for this subject, although the subject returned to soft contact lens wear and verbally reported that vision was normal. All adverse events resolved without further complications. A separate clinical study evaluated the effect of non-spherical (toric) peripheral curves on 45 astigmatic patients who were orthokeratology lens-naïve. Among the dispensed subjects, no significant adverse events were reported.
ATTENTION: Refer to the package insert for a complete listing of indications, warnings and precautions, clinical trial information, etc.
CAUTION: Federal (USA) law restricts this device to the sale by, or on the order of a licensed practitioner.
About Orthokeratology
Orthokeratology, or ortho-k, is a non-surgical procedure that is primarily used to correct nearsightedness (myopia). It uses specially designed contact lenses to temporarily reshape the cornea and improve vision. The lenses are worn overnight to gradually correct the shape of the cornea, allowing the eyes to focus light more effectively onto the retina.
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,500 employees and a presence in approximately 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario, with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on X, LinkedIn, Facebook and Instagram.
†Based on survey results from 13 eye care professionals who accessed and utilized the system.
References:
1 Lipson MJ. Contemporary Orthokeratology. 2019.
2 Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016;123(5):1036–42.
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