NEW DATA FROM JOHNSON & JOHNSON VISION DEMONSTRATES THE BENEFITS THAT NEW INNOVATIONS IN CATARACT SURGERY PROVIDE TO SURGEONS AND PATIENTS AND LOOKS AT THE ROLE ARTIFICIAL INTELLIGENCE MAY PLAY IN OPHTHALMOLOGY AT THE 2021 AAO ANNUAL MEETING

  • New Evidence Demonstrates TECNIS Synergy Provides Continuous Range of Vision* with Reduced Eyeglass Wear Reported by Patients
  • Clinical Data and Surgeon Assessment Points to Reduction of Ergonomic Burden with VERITAS Vision System
  • Research Shows Artificial Intelligence-Guided Image Recognition May Help Clinicians Estimate Cup-to-Disc Ratio 

SANTA ANA, CALIF. – November 8, 2021 – Johnson & Johnson Vision**, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies***, will present a range of company-sponsored studies supporting new innovations in its cataract surgery portfolio at the 2021 American Academy of Ophthalmology (AAO) Annual Meeting in New Orleans, November 12-15, 2021. In addition, new company-sponsored research will be presented, that looks at the accuracy of an artificial intelligence-derived algorithm to assess the cup-to-disc ratio, using only a photo. A complete listing of abstracts related to Johnson & Johnson Vision can be found on the AAO website.

“We’re dedicated to developing and delivering new research and innovations that provide surgeons and patients with more of the benefits they desire and expect,” said Rajesh Rajpal,**** MD, Chief Medical Officer and Global Head of Clinical and Medical Affairs, Johnson & Johnson Vision. “At AAO, we’re presenting more clinical evidence that shows our TECNIS Synergy PC-IOL provides a wide range of continuous vision*1 that today’s cataract patients expect, and that features of our VERITAS Vision System may help lessen musculoskeletal stress and fatigue for surgeons. Beyond our products and in an area of high interest for us, we are exploring the role that artificial intelligence may have in the clinical setting and presenting data from a review of an AI powered algorithm developed by the Data Science Institute at Columbia University.”  

In addition to presenting clinical data, Johnson & Johnson Vision is also supporting events throughout the week dedicated to empowering aspiring and young ophthalmologists, while promoting the importance of prioritizing diversity in the ophthalmology community.  

“Like Johnson & Johnson Vision, our partners in the ophthalmology community are committed to mentoring and promoting diversity within the ophthalmology community for the greater good of patients and doctors,” said Warren Foust,***** Worldwide President, Surgical at Johnson & Johnson Vision. "This weekend we are honored to support Women in Ophthalmology as they recognize remarkable women in our industry who continue to pave the way for ophthalmology. And we’re also proud to support the Minority Ophthalmology Mentoring Program as they help underrepresented in medicine (URiM) students on their path to ophthalmology residency.”

*Continuous 20/32 or better

Evidence Supports Range of Continuous Vision,*1 Reduced Eyeglass Wear with TECNIS Synergy PC-IOL
Visual acuity, contrast sensitivity, and depth perception are interrelated elements of vision that impact health-related quality of life.2,3 TECNIS Synergy IOL is a breakthrough presbyopia solution that delivers the widest† range of continuous vision*1 with best near, day and night. New data show the TECNIS Synergy (Model ZFR00V) was superior to a monofocal lens in providing a continuous range of vision,*1 with more than nine out of ten patients reporting reduced eyeglass wear.

  • Paper Presentation PA021: “Clinical Evidence Supporting the Range of Vision with a New Presbyopia-Correcting IOL with Hybrid Technologies.” Chang D; Thomas E; Sefton C, Tsai L; Nilplub J. Saturday, November 13th 2:24 PM – 2:30 PM

VERITAS Swivel Phacoemulsification Handpiece and Foot Pedal May Reduce Surgeon-Identified Musculoskeletal Stress During Phacoemulsification
A reported 17% of eye care physicians experienced hand/wrist musculoskeletal stress4 (MSS) while 52% to 80% reported back or neck pain.5,6 MSS affects ophthalmologists' well-being and can reduce time devoted to patient care, with 15% to 24% of ophthalmologists reporting they’ve limited their practice due to MSS.5 Preliminary results from clinical data and surgeon assessment suggest the use of the VERITAS Swivel Handpiece and foot pedal featured in the VERITAS Vision System may reduce these ergonomic burdens.

  • Poster Presentation PO144: “Musculoskeletal stress and phacoemulsification: Can surgeon-centered ergonomic designs be meaningful in the OR?" Schwam B; Pastuck T; Atiles L; Parizadeh D; Kasthurirangan S; Dykstra G; Toner A; Ji L; Colter J. 

Research Shows Artificial Intelligence May Be Used in the Clinical Setting to Measure Cup-to-Disc Ratio
In a novel study, investigators evaluated an artificial intelligence (AI)-based algorithm that utilizes the Google Cloud Platform to analyze fundus photos and estimate cup-to-disc ratio. 

"The use of AI has exploded in ophthalmology," said study investigator Dylan Stevens, MD, of New York University. "There is a great need for more robust screening tools to evaluate the optic nerve and better identify patients who need further evaluation. This AI-based algorithm was 99.2% precise in identifying the optic cup and 100% precise in identifying the optic disc."

  • Poster Presentation PO084: “Artificial Intelligence-Guided Image Recognition for Cup-to-Disc Estimation.” Stevens D; Young J; Scales C; Blackie C; Lee CH; Prumachuk J; Bareja R; Chaudhary W. 

*Continuous 20/32 or better
†vs Acrysof® IQ PanOptix® IOL, TECNIS Symfony™ IOL, TECNIS® Multifocal IOL (United States). Based on comparison of DFU defocus curves and a head-to-head clinical study vs. Acrysof® IQ PanOptix® IOL. DOF2020CT414

About The TECNIS® Family of IOLs 
At Johnson & Johnson Vision, quality begins with the platform. The TECNIS platform uses a proprietary combination of materials and design to deliver more for patients – more clarity with lower reflectance/lower dispersion vs competitor platform,7,8,9 ‡  low levels of chromatic aberration10 ‡‡, and almost complete elimination of spherical aberration.11 The TECNIS portfolio also delivers more image contrast - day and night - than the leading competitor platform,12,13 ‡‡‡ and more stability to stand the test of time.14,15,16 ‡‡‡‡ Finally, TECNIS delivers more choices for surgeons and patients - offering the broadest portfolio of IOLs, with solutions for vision across a variety of different visual conditions and lifestyles.17

About Johnson & Johnson Vision*
At Johnson & Johnson Vision*, part of 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, live better. Visit us at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook

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.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS Synergy™ IOL with TECNIS Simplicity™ Delivery System, Model DFR00V and TECNIS Synergy™ Toric II IOL with TECNIS Simplicity™ Delivery System, Models DFW150, DFW225, DFW300, DFW375

INDICATIONS 

The TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Synergy™ IOL which 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 TECNIS Simplicity™ Delivery System is used to fold and assist in inserting the TECNIS Synergy™ Toric II IOLs that are indicated for primary implantation for the visual correction of aphakia and for reduction of 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. Compared to an aspheric monofocal lens, the TECNIS Synergy™ IOLs mitigate the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.
 
WARNINGS

Intraocular lenses may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the eyesight of patients. Patients should have well-defined visual needs and be informed of possible visual effects (such as a perception of halo, starburst or glare around lights), which may be expected in nighttime or poor visibility conditions. Patients may perceive these visual effects as bothersome, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. The physician should carefully weigh the potential risks and benefits for each patient. Patients with a predicted postoperative residual astigmatism greater than 1.0 diopter, with or without a toric lens, may not fully benefit in terms of reducing spectacle wear. Rotation of the TECNIS Synergy™ Toric II IOL from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible, prior to lens encapsulation. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge. Do not attempt to disassemble, modify, or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design.

PRECAUTIONS

Interpret results with caution when using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duo chrome test. Confirmation of refraction with maximum plus manifest refraction technique is strongly recommended. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved. The TECNIS Synergy™ IOLs should not be placed in the ciliary sulcus. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS Synergy™ Toric II IOL. All preoperative surgical parameters are important when choosing a TECNIS Synergy™ Toric II IOL for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, the surgeon's estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. The effectiveness of TECNIS Synergy™ Toric II IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism < 1.0 diopter has not been demonstrated. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS Synergy™ and TECNIS Synergy™ Toric II IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower predicted postoperative astigmatism.

ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the VERITAS™ Vision System

Rx Only

INDICATIONS FOR USE: The VERITAS™ Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements

IMPORTANT SAFETY INFORMATION: Risks and complications of cataract surgery may include corneal burn. This device is only to be used by a trained licensed physician

ATTENTION: Reference the labeling for a complete listing of Indications and Important Safety Information

©Johnson & Johnson Vision Care Inc., 2021. All rights reserved.

1 TECNIS Synergy™ IOL with TECNIS Simplicity® Delivery System DFU, Z311421E
2 Shader RI (2019) Falls, Frailty, Vision and Aging. Clin Ther 41 (3): 369-372
. 3 Datta S, Foss AJ, Grainge MJ, Gregson RM, Zaman A et al. (2008) The importance of acuity, stereopsis, and contrast sensitivity for health-related quality of life in elderly women with cataracts. Invest Ophthalmol Vis Sci 49 (1): 1-6.
4 Kitzmann AS, Fethke NB, Baratz KH, Zimmerman MB, Hackbarth DJ et al. (2012) A survey study of musculoskeletal disorders among eye care physicians compared with family medicine physicians. Ophthalmology 119 (2: 213-220).
5 Honavar SG (2017) Head up, heels down, postureperfect: Ergonomics for an ophthalmologist. Indian J Ophthalmol 65 (8: 647-650).
6 Dhimitri KC, McGwin G, Jr, McNeal SF, Lee P, Morse PA et al. (2005) Symptoms of musculoskeletal disorders in ophthalmologists. Am J Ophthalmol 139 (1:179-181)
7 Zhao H, Mainster MA. Br J Ophthalmol. 2007; 91:1225–1229.
8 Negishi K et al. Arch Ophthalmol 2001; 119:1154-1158.
9 Krader CG. EUROTIMES 2011/2012;16/17: 18.
10 Data on File, DOF2018CT4007, Johnson & Johnson Surgical Vision, Inc. 2018
11 Piers P, Manzanera S, Prieto P, Gorceix N, Artal P. Use of adaptive optics to determine the optimal ocular spherical aberration. J Cataract Refract Surg. 2007 Oct;33(10):1721-62.
12 Data on File, DOF2018OTH 4004 Johnson & Johnson Surgical Vision, Inc. 2018. (Modular transfer function (MTF) is a measure of the amount of contrast transferred by the optics in a visual system. The higher the MTF value, the more contrast transferred to the image, resulting in higher image contrast.)
13 Nagata M, Matsushima H, Mukai K, Terauchi W, Senoo T, Wada H, Yoshida S. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. J Cataract Refract Surg. 2010 Dec;36(12):2056-60.
14 Nagata M, Matsushima H, Mukai K, Terauchi W, Senoo T, Wada H, Yoshida S. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. J Cataract Refract Surg. 2010 Dec;36(12):2056-60.
15 Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express.
16 Auffarth GU, et al. Analysis of optical purity and optical quality of a new extended range of vision IOL. Poster presented at: The 20th ESCRS Winter Meeting; February2016, Athens, Greece.
17 Freeman W. Market Scope - 2017 IOL report: a global market analysis for 2016 to 2022. P. 79, 137, 174. REF2018MLT4002

**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.
****Rajesh Rajpal is an employee of Johnson & Johnson Vision, Inc., serving as Chief Medical Officer and Global Head of Clinical and Medical Affairs.
*****Warren Foust is an employee of Johnson & Johnson Vision, Inc., serving as Worldwide President, Surgical Vision.
††Continuous 20/32 or better
††† Head-to-head clinical study vs. Acrysof® IQ PanOptix® IOL
‡Competitor platforms included are Hoya, Alcon & B&L Acrylic
‡‡Against IOLs that use Hoya, Alcon Acrylic, and B&L Silicone
‡‡‡Against Acrysof® IOL & Clareon IOL
‡‡‡‡Against Acrysof® IOL

PP2021CT6134