StemCell Therapy

SANTA ANA, Calif., July 20, 2021 /PRNewswire/ -- Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, today announced that 21 company-sponsored studies supporting cataract surgery outcomes will be presented at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting in Las Vegas Nevada, July 23-27, 2021. A complete listing of abstracts related to Johnson & Johnson Vision can be found on the ASCRS website.

"We're passionate about developing evidenced-based solutions that surgeons use to improve their patients' sight and wellbeing, as well as evaluating the clinical outcomes of those innovations," said Rajesh Rajpal,*** MD, Chief Medical Officer and Global Head of Clinical and Medical Affairs, Johnson & Johnson Vision. "This year at ASCRS we've more than tripled our presentations, offering a robust slate of clinical data, including data for our new TECNIS Synergy IOL2 and postmarket data evaluating the rotational stability of the TECNIS Toric II IOLs,1 as we know it will be beneficial for surgeons to consider when they are determining their cataract patients' treatment plans."

At the meeting, Johnson & Johnson Vision will also feature the new monofocal and PC-IOL lenses introduced this year, and its next-gen phaco emulsification system that received FDA 510(k) clearance earlier this year at its booth (#2813), host a case-based discussion on the new TECNIS Synergy IOL, and help bring the diverse ophthalmology community back together by sponsoring the OWL organization's Signature Event. Additionally, a skills transfer wet-lab for VERITAS Vision System will be featured in the Johnson & Johnson Vision booth (#2813), allowing customers to be among the first in the United States to receive hands-on experience with the system.

Evidence Supports Excellent Visual Performance and Rotational Stability with TECNIS IOLs1,2,3

Visual acuity, contrast sensitivity, and depth perception are highly interrelated elements of vision and impact health-related quality of life and safety.4,5 IOL data being presented utilize novel rotation measurement method to evaluate rotational stability of the TECNIS Toric II IOL,1 and reviews head-to-head data for the TECNIS Synergy IOL, showing the lenses deliver excellent performance, image contrast, and outcomes for cataract patients.2,6

Data Shows TearScience LipiFlow Treatment Prior to Cataract Surgery Optimizes Outcomes7

The incidence of ocular surface disease in patients presenting for cataract surgery is over 80%8 and 60% of cataract surgery candidates are asymptomatic.9 In alignment with current ASCRS clinical guidelines, the proactive diagnosis and management of MGD in the preoperative cataract patient is recommended.10 Data presented evaluates the improvements in visual acuity, reporting of halos, and improvement of MGD function in patients treated prior to bilateral cataract surgery.

Evaluation Demonstrates Improved Performance of VERITAS Vision System Fluidics Packs

Anterior chamber stability is key to successful outcomes for patients undergoing cataract surgery, while post-occlusion surge is a main source of chamber instability during cataract surgery.11,12,13 Optimal fluidics management may reduce complication rates.14 Key datawill assess if the new Hybrid Fluidics Technologyon the VERITAS Vision System minimize post-occlusion surge and protects intraocular structures to provide exceptional chamber stability.

All educational content of the ASCRSASOA Annual Meeting is planned by its program committee, and ASCRSASOA does not endorse, promote, approve, or recommend the use of any products, devices, or services.

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.

Continuous 20/32 or better

Head to head clinical study vs. Acrysof IQ PanOptix IOL.

About The TECNISFamily 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 withlower reflectance/lower dispersion vs competitor platform,15,16,17 low levels of chromatic aberration 18, and almost complete elimination of spherical aberration.19 The TECNIS portfolio also delivers moreimage contrast- day and night -than the leading competitor platform 20,21 and more stabilityto stand the test of time.21,22,23Finally, TECNIS delivers more choice for surgeons and patients - offering thebroadest portfolio of IOLs, with solutions for vision across a variety of different visual conditions and lifestyles.24

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 & JohnsonMedical 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.

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

AgainstAcrysof IOL

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 duochrome 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 TECNIS TORIC AND TECNIS TORIC II 1-PIECE IOL

Rx Only

CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician.

INDICATIONS

The TECNISToric II 1-Piece and TECNIS Toric 1-Piece IOL posterior chamber lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNISToric II 1-Piece and TECNIS Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. The clinical study for the TECNIS Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. The TECNIS Toric II 1-Piece and TECNIS Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS Toric II 1-Piece and TECNIS Toric 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30 may increase postoperative refractive cylinder.

PRECAUTIONS

Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. Refer to the TECNIS Toric II 1-Piece and TECNIS Toric 1-Piece IOL Directions for Use for a complete description of the preexisting conditions and intraoperative complications. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the clinical study. When the insertion system is used improperly, the haptics of the TECNIS Toric II 1-Piece and TECNIS Toric 1-Piece IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. Do not reuse, resterilize, or autoclave.

ADVERSE EVENTS

The most frequently reported cumulative adverse event that occurred during the TECNIS Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures).

ATTENTION

Reference the Directions for Use labeling for a complete listing of Indications and 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

INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPIFLOWThermal Pulsation System

Rx Only

INDICATIONS: The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

CONTRAINDICATIONS: Do not use the LipiFlow System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.

PRECAUTIONS: Use of the LipiFlow System in patients with the conditions described in the LipiFlow instructions for use may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions.

WARNINGS: Caution: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the device by children or incapacitated persons may be dangerous.

ADVERSE EFFECTS: Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in:

ATTENTION

Reference theLipiFlow Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions.

*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.

Johnson & Johnson Vision, 2021. All rights reserved.

1 DOF2021CT4012 Johnson & Johnson Surgical Vision Inc, 2021

2 DOF2020CT4014 - Forte 1: A Comparative Clinical Evaluation of a New TECNIS Presbyopia Correcting Intraocular Lens Against a PanOptix Intraocular Lens- DEFOCUS CURVES AND VISUAL ACUITY RESULTS

3 DOF2020CT4015- ("Forte 1"): A Comparative Clinical Evaluation of a New TECNIS Presbyopia Correcting Intraocular Lens Against a PanOptix Intraocular Lens- SPECTACLE WEAR AND SATISFACTION RESULTS

4 Shader RI (2019) Falls, Frailty, Vision, and Aging. Clin Ther 41 (3): 369-372.

5 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.

6 Johnson & Johnson Vision. DOF2021CT4012 v1.0

7 DOF2021MLT40003 TearScience LipiFlow (Tahoe Study)

8 Gupta, P K.; Drinkwater, O; VanDusen, K; Brissette, A; Starr, C. Prevalence of ocular surface dysfunction in patients presenting for cataract surgery evaluation. J Catarct Refract Surg 2018; 44:1090-1096

9 Trattler WB, Majmundar PA, Donnenfeld ED, McDonald MB, Stonecipher KG, Goldberg DF. The Prospective Health Assessment of Cataract Patients Ocular Surface (PHACO) study: the effect of dry eye. Clin Ophthalmol 2017; 11:1423-1430.

10 Starr C, et al. The ASCRS Cornea Clinical Committee. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019;45:669-684).

11 Nicoli M, Dimalanta R, Miller K (2016) Experimental anterior chamber maintenance in active versus passive phacoemulsification fluidics systems. J Cataract Refract Surg 42: 157-162.

12 Chang D (2008) Improving Surgical Safety With Modern Phaco Technology. Cat & Refr Surg Today 11; 1-3.

13 Zeng M, Wang R, Cheng B, Yang C, Chen Y, Liu X (2020) Effectiveness of operative intraocular lens use on improving surgical safety for dense cataract phacoemulsification: a randomized controlled trial. Sci Rep 10, 1600. doi.org/10.1038/s41598-020-58597-0.

14 Benjamin L (2018) Fluidics and rheology in phaco surgery: what matters and what is the hype? Eye; 32: 204-209.

15 Zhao H, Mainster MA. Br J Ophthalmol. 2007; 91:12251229.

16 Zhao H, Mainster MA. Br J Ophthalmol. 2007; 91:12251229.

17 Krader CG.EUROTIMES 2011/2012;16/17: 18.

18 Data on File, DOF2018CT4007, Johnson & Johnson Surgical Vision, Inc. 2018

19 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.

20 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.)

21 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.

22 Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express.

23 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.

24 Freeman W. Market Scope - 2017 IOL report: a global market analysis for 2016 to 2022. P. 79, 137, 174. REF2018MLT4002

PP2021CT5310

SOURCE Johnson & Johnson Vision

https://www.jjvision.com/

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Johnson & Johnson Vision Presents Scientific Data Validating Improved Surgical Outcomes With Latest Cataract Innovations And Legacy MGD Treatment...

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