Johnson & Johnson Vision Presents First Myopia Clinical Research Findings from Ground-Breaking Collaboration with SERI and SNEC; and New Contact Lens, Intraocular Lens and Equipment Data at ARVO Annual Meeting 2020
- New research measuring Myopia disease progression in children
- Drug release findings for investigational antihistamine-releasing contact lens
- New data on next generation extended depth of focus technology used in TECNIS Symfony Plus Intraocular Lenses (IOLs)
- New data on CATALYS cOS 6.0 with Advanced Astigmatism Management, new software for the CATALYS Precision Laser System
Jacksonville, Fla, and Santa Ana, Calif., June 12, 2020 -- Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, will present the first clinical research findings from its comprehensive Myopia clinical research program with the Singapore Eye Research Institute (SERI) and Singapore National Eye Centre (SNEC), as well as new data on contact lens and surgical innovations at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2020), which is being held as a virtual congress with Johnson & Johnson Vision author video presentations published on June 15. Access to Johnson & Johnson Vision accepted studies and author videos can be gained through ARVOLearn.
“Johnson & Johnson Vision is focused on delivering innovation that meets major unmet needs,” said Xiao-Yu Song, MD, PhD, Global Head of Research and Development, Johnson & Johnson Vision Care, Inc. “We are excited to present our first research at ARVO 2020 from our unique public-private Myopia strategic partnership that is working to address this growing epidemic. We will also share the latest findings on many investigational technologies, including our drug-eluting contact lenses, extended depth of focus and astigmatism-correcting IOL designs, and our laser cataract surgery operating system.”
BUILDING A BETTER UNDERSTANDING OF MYOPIA
By 2050, half of the world’s population is expected to be myopic, with a disproportionate impact on our children.1 Johnson & Johnson Vision is addressing this public health crisis by building a better understanding of the science and biology behind myopia and developing comprehensive programs to address and treat the disease.
At ARVO 2020, Johnson & Johnson Vision, together with SERI and SNEC, will present the first five studies from the group’s unique public-private strategic partnership. Since the start of the collaboration in April 2019, the group initiated nine research projects that include four clinical cohorts with 631 participants. The research projects are providing real-world evidence to better understand why Myopia develops, how it progresses, and how it might be intercepted by investigating underlying mechanisms. Key data presented includes:
- Annual Myopia Progression and Subsequent Year Progression in Singaporean Children. Brennan, N et al. This study explored predictors of myopia progression, including whether prior year progression correlates with the year that follows. In the latest findings from the Singapore Cohort Study of the Risk Factors for Myopia, study authors find that prior year annual Myopia progression correlates more closely with immediate subsequent year Myopia progression. However, it cannot as a single factor fully predict long-term Myopia progression. The authors recommend that patients should receive annual check-ups. Factors including age of Myopia onset and parental Myopia should be considered in determining treatment. Link to study.
- A Microperimetric Evaluation of Macular Function in Highly Myopic Eyes with Myopic Macular Degeneration. Wong, Qiu Ying et al. Today, it is challenging to get accurate measures of the onset and progression of vision impairment associated with Myopia-related pathologies, such as macular degeneration. In this study, investigators explored using microperimetry to measure macular sensitivity and correlate it with axial length; best corrected visual acuity; and the severity of myopic macular degeneration (MMD). They found that macular function as measured by microperimetry may be a more sensitive marker of visual function than visual acuity in eyes with MMD. Link to study.
DATA ON FIRST-EVER ANTIHISTAMINE-RELEASING CONTACT LENS
Ocular allergy is a pervasive condition that affects up to 20 percent of the US population, with a similar prevalence worldwide.2 Allergic conjunctivitis is the most common type of ocular allergy and its primary symptom, itchy eyes, can have a significant impact on contact lens wearers.
Johnson & Johnson Vision is working to address this major unmet need through the development of an investigational antihistamine-releasing contact lens (etafilcon A with 0.019 mg ketotifen). Research published at ARVO 2020 shares new data on the lens’s drug release and clinical efficacy over time:
- The Ex Vivo Drug Amount and Clinical Efficacy of an Antihistamine Releasing Contact Lens Over Time. Pall, Brian. In this study, Johnson & Johnson Vision ketotifen containing investigational lenses exhibited a consistent release of the antihistamine during the wear-period. Approximately 80 percent of the drug present in the lenses was released every hour based on what was remaining in the lens over a 5-hour period. This release profile was consistent with the 15-minute onset, and 12-hour duration of action efficacy results from previous studies. Link to study.
EXTENDED DEPTH OF FOCUS LENS INNOVATION
Cataract patients’ preference for presbyopia-correcting intraocular lens (PCIOLs) can vary based on individual lifestyle needs, and Johnson & Johnson Vision is advancing programs to ensure the broadest range offerings and highest performance. Extended depth of focus (EDOF) technology was pioneered by Johnson & Johnson Vision in 2016 to provide patients with a PCIOL with better continuous range of vision and image quality compared to multifocal lenses. Since the first EDOF lens, TECNIS Symfony, was introduced, Johnson & Johnson Vision has continued to innovate EDOF technology. Research published at ARVO 2020 shares new data on Johnson & Johnson Vision EDOF designs:
- Optical and Predicted Visual Performance of Multifocal and Extended Depth of Focus Designs. State, Mihai. In this study, authors compared Johnson & Johnson Vision EDOF designs with multifocal lenses and found that the latest EDOF IOL lens in the Symfony PLUS IOL family provided superior distance and intermediate image quality, while maintaining comparable near vision. Link to study.
ASTIGMATISM MANAGEMENT SOLUTIONS
Astigmatism reduces distance and near visual acuity, vision quality, and depth perception. In the U.S., 38 percent of patients with cataracts have moderate to severe astigmatism (≥ 1.00 D).3 Yet astigmatism is corrected in less than half of patients at the time of cataract surgery, due to limitations in currently available astigmatism treatment modality and toric IOL technology. Even subtle shifts off the target IOL placement can impact a patient’s outcome, so surgeons need astigmatism solutions that help ensure accurate astigmatism assessment and IOL placement. Link to study.
- Automatic cyclorotation measurement with a femtosecond cataract laser. Dewey, David et.al. In this study of CATALYS cOS 6.0 with advanced astigmatism management, a new software for the CATALYS Precision Laser System, pre-op image pairs were collected from a CASSINI topographer, and CATALYS Precision Laser for patients who underwent cataract surgery at two clinical sites. The image pairs were graded for cyclorotation between the pre-op and docked conditions by 3 different graders aided by an image-based computer grading tool. Data showed CATALYS automatic cyclorotation measurement and image guided iris registration can be registered to pre-op CASSINI images in 94% of eyes with an accuracy of better than 2 degrees. Link to study.
Key Johnson & Johnson Vision Scientific Abstracts At ARVO Annual Meeting 2020:
Myopia: SERI – J&J Vision Joint Research
Annual Myopia Progression and Subsequent Year Progression in Singaporean Children. Brennan, N. et al.
A Microperimetric Evaluation of Macular Function in Highly Myopic Eyes with Myopic Macular Degeneration. Wong, Qiu Ying, Singapore Eye Research Institute.
Axial length/corneal radius of curvature ratio (AL/CR) in children on atropine eye drops. Chia, Audrey.
Influence of Greater Axial Length on Prevalence of Myopic Maculopathy in Cohort of Highly Myopic Eyes. Yu, Daryle Jason G, Singapore Eye Research Institute.
Comparison of Refractive Changes in Myopia Progression in Guinea Pig Myopic Models. Jiang, Liqin, Singapore Eye Research Institute; Kathrani, Biten, et al.
Evaluating On-Eye Wavefront Aberrations of a Soft Contact Lens with an Optical Design Simulating Orthokeratology. Cheng, Xu.
The Ex Vivo Drug Amount and Clinical Efficacy of an Antihistamine Releasing Contact Lens Over Time. Pall, Brian.
Optical and Predicted Visual Performance of Multifocal and Extended Depth of Focus Designs. State, Mihai.
Effect of Blocking Violet Light in Extended Depth of Focus Intraocular Lenses. Faria-Ribeir, Miguel.
Trend in Glistening Density in Acrylic Inraocular Lenses and Its Relation to Stray Light Performance. van der Mooren, Marrie.
Effect of Pupil Size on Optical and Visual Performance of Monofocal IOLS. Koopman, B.
Contrast Sensitivity Safety Limits for IOLS – Risk of False Negative and False Positive Conclusions. Rosen, Robert.
Evaluation of the Rotational Stability of Four Prototype Toric IOL Haptic Designs. Straker, Benjamin.
Light Intensity Distribution of Diffractive Ophthalmic Lenses. Weeber, Henk.
Cataract & Refractive
Automatic cyclorotation measurement with a femtosecond cataract laser. Dewey, David.
Methods and Design to Reduce Cyclotorsion and Decentration Error for Corneal Lenticule Extraction Surgery with a Next-Generation Femtosecond Laser System. Voorhees, Andrew.
Comparison of flap and iLex induced light scattering at retina between new and on market femtosecond lasers. Bing, Li.
Evaluating the accuracy of refractive lenticule created by a new femtosecond laser in glass. Chen, Li.
About Johnson & Johnson Vision*
At Johnson & Johnson Vision, a division of the Johnson & Johnson Medical Devices Companies, we have a bold ambition: to change the trajectory of eye health worldwide. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better, and live better. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
About Johnson & Johnson Medical Devices Companies**
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision, and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.
*Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
** The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
Cautions Concerning Forward-Looking Statement
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding certain new products and products in development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson Surgical Vision, Inc. and/or Johnson & Johnson Vision Care, Inc. (“Johnson & Johnson Vision”) and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Johnson & Johnson Vision nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS SYMFONY™ PLUS OPTIBLUE™ and TECNIS SYMFONY™ PLUS TORIC II OPTIBLUE™ EXTENDED RANGE OF VISION IOLs CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.
INDICATIONS FOR USE: The TECNIS Symfony™ PLUS OptiBlue™ Extended Range of Vision IOL, Model ZHR00V, is indicated for primary implantation for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity while maintaining comparable distance visual acuity, resulting in reduced eyeglass wear. The lens is intended for capsular bag placement only. The TECNIS Symfony™ PLUS Toric II OptiBlue™ Extended Range of Vision IOL, Models ZHW150, ZHW225, ZHW300, ZHW375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lenses provide improved intermediate and near visual acuity while maintaining comparable distance visual acuity, resulting in reduced eyeglass wear. The lenses are intended for capsular bag placement only.
IMPORTANT SAFETY INFORMATION: Physicians considering lens implantation should carefully weigh the potential risk/benefits ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes. Special consideration of potential visual problems should be made before implanting the lens in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease. Rotation of the IOLs away from their intended axis can reduce their astigmatic correction and misalignment greater than 30° may increase postoperative refractive cylinder. The safety and effectiveness of the lenses have not been substantiated in patients with preexisting ocular conditions and intraoperative complications.
INDICATIONS AND IMPORTANT SAFETY INFORMATION for the CATALYS® Precision Laser System:
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. The system should be used only by qualified physicians who have extensive knowledge of the use of this device and have been trained and certified.
ATTENTION: Reference the labeling for a complete listing of Important Indications and Safety Information.
INDICATIONS: The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
CONTRAINDICATIONS: The CATALYS System should not be used if you are not a candidate for cataract surgery, have certain pre-existing corneal problems or eye implants; or if you are younger than 22 years of age. Tell your doctor about any eye-related conditions, injuries, or surgeries.
PRECAUTIONS: Patients must be able to lie flat on their backs and motionless during the procedure. Patients must be able to tolerate local or topical anesthesia. Tell your doctor if you are taking any medications such as alpha blockers (like Flomax® to treat an enlarged prostate) as these medications may affect how the doctor does the cataract surgery.
ADVERSE EFFECTS: Complications associated with the CATALYS System include mild broken blood vessels or redness on the white part of your eye, which may last for a few weeks. Other potential risks associated with cataract surgery may occur. These risks may include but are not limited to corneal swelling and/or abrasion, lens capsular tear, infection, inflammation, eye discomfort, reduced vision. Talk to your doctor regarding all the potential risks associated with these procedures.
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For further information, contact:
Carlos Taveras (Contact Lens)
Johnson & Johnson Vision
John Lacey (R&D)
Johnson & Johnson Vision
Pascale Communications, LLC
1 Holden et al Ophthalmology 2016
2 Pall et al Cornea 2019
3 Hill WE (2019) Prevalence of corneal astigmatism prior to cataract surgery. Available at: https://www.doctor-hill.com/iol-main/astigmatism_chart.htm