Johnson & Johnson Vision announces launch of ELITA™ Platform to Correct Myopia with New SILK Procedure at the European Society of Cataract and Refractive Surgeons Congress

THIS PRESS RELEASE WAS UPDATED WITH ADDITIONAL INFORMATION ON SEPT. 1, 2023

Next-generation laser vision correction provides next-day results and recovery^1,2

• The next-generation ELITA^TM Femtosecond Laser to correct myopia with the new SILK procedure^**
• The latest innovation in extended depth of focus (EDOF) intraocular lenses (IOLs) will be shared with invited surgeons.
• Supporting ESCRS' Mission Zero target through ongoing sustainability efforts
• More than 30 abstracts supported by Johnson and Johnson Vision to be presented across a range of equipment and IOLs including: TECNIS Synergy® IOL, TECNIS Eyhance® IOL and ELITA™ Femtosecond Laser
• Participating in iNovation sessions on presbyopia, the re-emergence of refractive surgery and myopia: the next pandemic

**The ELITA Femtosecond Laser Platform has received FDA 510(k) clearance for the creation of LASIK flaps in the U.S. and is not approved for lenticular removal/SILK procedure in the U.S.

LONDON, Aug. 30, 2023 /PRNewswire/ -- Johnson & Johnson Vision^*, a global leader in eye health and part of Johnson & Johnson MedTechⁱ, will announce the launch of a next-generation laser vision correction solution, the ELITA^TM Platform, at the 41^st European Society of Cataract and Refractive Surgeons (ESCRS) congress, 8-12 September 2023. The congress will also showcase a range of breakthrough data, with over 30 abstracts supported by Johnson & Johnson Vision accepted for presentation.

The ELITA^TM Platform enables surgeons to perform refractive correction on patients with myopia, with or without astigmatism, using the new SILK (Smooth Incision Lenticule Keratomileusis) procedure. With an ultra-precise laser pulse and fast laser delivery system, the ELITA^TM Platform provides surgeons with a consistently smooth and easy lenticular removal, offering exceptional vision correction with next-day results and recovery.^1,2,3

The SILK procedure helps correct myopia through an often quick and minimally invasive process. The precise ELITA^TM Femtosecond Laser uses fine laser pulses to gently create a small disc-shaped piece of tissue called a lenticule in the cornea after the eye is numbed. The lenticule is then delicately removed through a microscopic incision and the smooth lenticule removal reshapes the cornea, correcting the eye to see flawlessly.1,2

An integrated blend of sophisticated technologies enables surgeons to perform the SILK procedure effortlessly and precisely to yield next-day results for patients.^1,2

• Ultra-Precise Pulse delivers better quality treatment of corneal tissue¹
• Ultra-Fast Delivery System enables contiguous placement of laser pulses for exceptionally smooth tissue surface
• Sub-Micron Digital-Encoder Controlled Scanning System allows a high-degree of pulse placement and superior optical performance across the entire treatment area¹
• Industry-first biconvex lenticule: Designed for better quality of vision. Reduces cutting of corneal nerves and provides fast regeneration for a healthy ocular surface

"We are delighted to launch our next-generation ELITA^TM Platform at ESCRS this year as well as showcase our broad range of ophthalmic innovations to our surgical customers", said Jacqueline Henderson, President, EMEA, Johnson & Johnson Vision. "We have a rich heritage of innovation at Johnson & Johnson Vision, and we're proud to offer surgeons and their patients equipment and IOLs that serve the eye health needs of patients across their lifetime".

The Johnson & Johnson Vision ESCRS Booth (#B202) will have live demonstration areas for surgeons to experience first-hand the ELITA^TM Femtosecond Laser as well as other leading Johnson & Johnson Vision products. Additionally, attendees will be able to participate in the Toric VR Simulator experience alongside dry labs and meet the expert sessions at the booth and in the Johnson & Johnson Vision Lighthouse.

Key scientific abstracts supported by Johnson & Johnson Vision
The congress, taking place this year at the Messe Wien Exhibition & Congress Centre in Vienna, will also see over 30 scientific communications from both Johnson & Johnson Vision sponsored studies and investigator-initiated studies (IIS) being presented, including:

ELITA^TM Femtosecond Laser

• Epithelial Corneal Nerves and Stromal Wound Healing Post Lenticular Extraction Using New Femtosecond Laser
• Evaluation Ease of Lenticule Removal and Visual Outcomes After a Lenticule Procedure with ELITA^TM Femtosecond Laser Platform

TECNIS Eyhance® Intraocular Lens

• Performance Comparative of Monofocal IOL with Enhanced Features for Intermediate Vision to Current Standard Monofocal Lens
• A Scoping Review On The Placement Of Enhanced Monofocal Between Conventional And Extended Depth Of Focus Intraocular Lenses

TECNIS Synergy® Intraocular Lens

• Safety And Efficacy Outcomes With A New Continuous-Range-Of-Vision Intraocular Lens

TECNIS Synergy® Toric II Intraocular Lens

• 6 Month Follow Up Comparison Of Rotational Stability Between Zeiss At Lisa 939 And Synergy Toric II For Correction Of Anisometropia With Astigmatism And Presbyopia
• Refractive Results After Cataract Surgery And Implantation Of A Trifocal Intraocular Lens– Model DFW-375 Tecnis Synergy Toric

TECNIS Symfony® and TECNIS Symfony® OptiBlue Intraocular Lenses

• Impact of Violet Light Filtration and High-Resolution Lathing on the Clinical Performance of a Diffractive Extended Depth of Focus IOL

A complete listing is available at: https://congress.escrs.org/programme/online-programme/

Other representatives from Johnson & Johnson Vision will be participating in events throughout ESCRS 23, including ESCRS iNovation Day on the 8^th at the Messe Wien Exhibition & Congress Centre.

Jacqueline Henderson, President EMEA, Johnson & Johnson Vision will be taking part in the European industry leadership roundtable on visions for the next 5 years, Raj Rajpal, Chief Medical Officer, Johnson & Johnson Vision will be joining the Managing presbyopia from early stage to cataracts panel discussion, Xiao Yu Song, Global Head of R&D, Johnson & Johnson Vision will discuss Myopia: The next pandemic and Tobin Island, Senior Director, Laser and Software, Johnson & Johnson Vision will be talking about the re-emergence of refractive surgery: lenticule extraction and phakic IOLs.

Education and interactive sessions
Johnson & Johnson Vision is also hosting a series of educational and interactive sessions aimed at sparking conversation and providing an opportunity to share, discuss and learn from leading experts in the field of ophthalmology. These include:

• EuroTimes Satellite Symposium – SILK: Re-Defining Technology Innovation with the New Elite in Laser Refractive Surgery. Room Strauss 3. 9^th September, 13.00-14.00
• IME Symposia – Demystifying Common Misunderstandings with Refractive IOL Procedures. Room A3. 9^th September, 16.30-17.30
• IME Symposia – The Future of Refractive Surgery, Lenticle Extraction, Phakic IOLs and Beyond. Room A3. 10^th September 2023, 09.30-10.30
• EuroTimes Satellite Symposia – Regaining Pure Vision in Intermediate Contrast. Room A4. 10^th September, 13.00-14.00

Sustainability at ESCRS
Following Johnson & Johnson Vision's recognition at the 2022 ESCRS congress for its sustainability efforts, it remains steadfast on tackling key issues that affect us all, from recycling and reducing our carbon footprint, to limiting our use of natural resources. This year the booth will include the following elements:

• Up to 90% of the Booth will be made from recycled or recyclable sources and materials and 90% of the Booth materials will be reused after the congress
• Offsetting 100% of our CO2 emissions from the electricity used at the Booth
• We are providing almost entirely locally sourced vegan food, delivered to us from within a 30km radius of the congress centre
• Onsite recycling for anyone who has picked up paper elsewhere at the congress, so they can dispose of it in a sustainable way.
• The booth will incorporate a digital tree auto calculating in real time the amount of CO2 saved on the booth
• Two bicycles on-site to provide a sustainable option for visitors to recharge their digital devices

Driving diversity and inclusion
To further build upon its commitment to equality and inclusion, Johnson & Johnson Vision will also be hosting the second Women in Ophthalmology networking and mentorship event during ESCRS. A host of influential women who work in ophthalmology, including Professor Beatrice Cochener, Professor Rita Mencucci and Dr. Nancy Al Raqqad will meet for an engaging and collaborative discussion on the power of success of women in ophthalmology, bringing their own diverse viewpoints and personal stories to help continue our mission to cultivate a productive and inclusive environment in eye health.

For more information visit the Johnson & Johnson Vision booth #B202.

About Johnson & Johnson Vision*
At Johnson & Johnson Vision*, part of Johnson & Johnson MedTech**, as a global leader in eye health we have a bold ambition: Vision Made Possible — paving the way for a new future of eye health to support the full spectrum of pediatric, adult and aging eyes. Through cutting-edge innovation, scientific expertise, and advanced technologies, we are transforming the way patients see and experience the world. At every step of the eye health journey, we stand as a trusted partner, making dependable outcomes possible for customers and patients. And, in communities with greatest need, we work in collaboration to expand access to quality eye care — for all. Visit us at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook.

About Johnson & Johnson MedTechⁱ
At Johnson & Johnson MedTechⁱ, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

About Myopia
Myopia, also called nearsightedness, is a chronic and progressive disease that poses the biggest eye health threat of the 21^st century.4,5,6,7. Half of the world's population is projected to be myopic by 2050, with nearly one billion people expected to have high myopia8. Refractive surgery can correct myopia, allowing patients to clearly see distant objects without glasses or contact lenses.4

© Johnson & Johnson Surgical Vision, Inc. 2023. All rights reserved.

IMPORTANT SAFETY INFORMATION – Europe
As with any medical procedure, risks and potential complications may occur. Please consult your eye care specialist for detailed information and to discuss these possible risks and complications with you prior to the procedure.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR ELITA™ FEMTOSECOND LASER

INDICATIONS FOR USE:

FLAP:
The ELITA^TM Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.

SILK:
The ELITA^TM Femtosecond Laser System is indicated for corneal refractive lenticule removal in the reduction or elimination of myopia with and without astigmatism up to -12.00 D sphere, up to -6.00 D cylinder, with the sum of sphere and cylinder between -1.00 D and -12.00 D using minus cylinder convention.

The ELITA^TM System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

The ELITA^TM Patient Interface is designed for exclusive use with the ELITA^TM System and indicated for corneal resection surgery. The Patient Interface is intended for use on one eye and must not be reused.

INTENDED USE/PURPOSE:

FLAP:
The ELITA^TM Femtosecond Laser System is an ophthalmic femtosecond laser intended to create a corneal flap in patients undergoing LASIK surgery or other surgery treatment requiring initial lamellar resection of the cornea. The ELITA^TM platform is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre- sterilized applanation cone, intended for single-use. The ELITA^TM Patient Interface is designed for exclusive use with the ELITA^TM platform and indicated for corneal resection surgery. The Patient Interface is intended for use on one eye and must not be reused. The ELITA^TM platform should only be operated by, or under the direct supervision of a trained physician with certification in laser safety and in the use of the ELITA^TM platform for corneal flaps.

SILK:
The ELITA^TM Femtosecond Laser System is an ophthalmic femtosecond laser intended for flapless refractive correction via lenticule creation and removal, which alters the curvature of the corneal surface so as to correct a patient's refraction. It is indicated for the reduction or elimination of myopia with and without astigmatism. The ELITA^TM Femtosecond Laser System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use. The ELITA^TM Patient Interface is designed for exclusive use with the ELITA^TM System and indicated for corneal resection surgery. The Patient Interface is intended for use on one eye and must not be reused. The ELITA^TM System should only be operated by, or under the direct supervision of a trained physician with certification in laser safety and in the use of the ELITA^TM System for Smooth Incision Lenticular Keratomileusis (SILK^TM) treatments.

CONTRAINDICATIONS:

FLAP:
Lamellar resection for the creation of a corneal flap using the ELITA^TM System is contraindicated if any of the following conditions exist.

Contraindications include the following, but are not limited to:

• Corneal edema, Corneal lesions, Hypotony, Glaucoma, Keratoconus, Existing corneal implant, Corneal Dystrophy, Unstable Refractive error within the past year prior to treatment, Prior refractive surgery.

SILK:
Lamellar resection for the creation of a corneal lenticule using the ELITA System is contraindicated if any of the following conditions exist.

Contraindications include the following, but are not limited to:

• Corneal edema, Corneal lesions, Hypotony, Glaucoma, Keratoconus, Existing corneal implant, Corneal Dystrophy, Unstable Refractive error within the past year prior to treatment, Prior refractive surgery.

UNDESIREABLE SIDE EFFECTS/ADVERSE EFFECTS:

FLAP:
Undesirable Side Effects/Adverse Effects: Possible complications resulting from this surgery include the following. Potential complications are not limited to those included in this list.

• Diffuse lamellar keratitis (DLK), Corneal edema, Corneal pain, Epithelial ingrowth, Epithelial defect, Infection, Corneal infiltrate/ulcer, Delayed healing, Corneal abrasion, Corneal erosion, Corneal haze, Corneal scar, Corneal scoring, Inhomogeneous stromal bed, Eye pain/excessive tearing/eye redness, Inflammation of the episcleral, Iritis/Uveitis, Unexpected loss of corneal tissue, Corneal ectasia, Elevated IOP, Hemorrhage, Subconjunctival hemorrhage, Venous and arterial blockage, Retinal vascular accidents, Ocular penetration, Cataract formation, Dysphotopsia, Blurry vision or halo/starburst/glare around lights at night, Ghost/ double images, Foreign body sensation or dry eye, Ptosis, Anesthesia/drug reactions, Transient light sensitivity syndrome, Peripheral light spectrum/rainbow glare

SILK:
Undesirable Side Effects/Adverse Effects: Possible complications resulting from this surgery include the following. Potential complications are not limited to those included in this list.

• Diffuse lamellar keratitis (DLK), Corneal edema, Corneal pain, Epithelial ingrowth, Epithelial defect, Infection, Corneal infiltrate/ulcer, Delayed healing, Corneal abrasion, Corneal erosion, Corneal haze, Corneal scar, Corneal scoring (Spoke-wheel like or striae), Inhomogeneous stromal bed, Eye pain/excessive tearing/eye redness, Inflammation of the episcleral, Iritis/Uveitis, Unexpected loss of corneal tissue, Corneal ectasia, Elevated IOP, Intraocular Hemorrhage, Subconjunctival hemorrhage, Venous and arterial blockage, Retinal vascular accidents, Ocular penetration, Cataract formation, Dysphotopsia, Blurry vision or halo/starburst/glare around lights at night, Ghost/ double images, Foreign body sensation or dry eye, Anisometropia, Ptosis, Vision correction regression, Anesthesia/drug reactions, De- centered lenticule, Incomplete lenticule creation, Lenticule tearing or inability to remove lenticule, Anterior corneal tear, Anterior corneal melt, Lenticule too deep or too shallow in the Cornea, Under or over refractive correction, Induced higher order aberrations, Transient light sensitivity syndrome, Peripheral light spectrum/rainbow glare

Vision Threatening Complications (these complications are uncommon, but possible following refractive surgery):

• Perforation of the cornea, Retinal detachment, Partial or total loss of vision or eye.

Intended Patient: Adults 18 years old or older with refractive error.
NOTE: Pregnant or nursing women were not included in the clinical trials conducted.

1. DOF2023RF4002. ELITA^TM Femtosecond Laser Device Description
2. DOF2023RF4003. ELITA™ femtosecond laser SILK™ procedure long term safety and effectiveness – Subset of Phase 3 data (India sites only)
3. ARVO 2023 LASIK Flap Accuracy Comparison Between A New Femtosecond Laser and iFS, Mahipal Sachdev
4. Flitcroft DI et al. IMI–Defining and classifying myopia: a proposed set of standards for clinical and epidemiologic studies. Invest Ophthalmol Vis Sci. 2019;60:M20-30.
5. Donovan L, Sankaridurg P, Ho A et al. Myopia progression rates in urban children wearing single-vision spectacles. OVS 2012;89(1):27-32.
6. ** Pärssinen O, Kauppinen M. Risk factors for high myopia: a 22-year follow-up study from childhood to adulthood. Acta Ophthalmologica. 2019;97(5):510-518.
7. ‡‡ Hu Y, Ding X, Guo X, Chen Y, Zhang J, He M. Association of Age at Myopia Onset with Risk of High Myopia in Adulthood in a 12-Year Follow-up of a Chinese Cohort. Jama Ophthalmol. 2020;138(11):1129-1134. doi:10.1001/jamaophthalmol.2020.3451.
8. Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo K, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 to 2050. Ophthalmol.
   2016;123(5):1036-1042. doi: 10.1016/j.ophtha.2016.01.006.

0155-3005 Rev B_OUS EN FLAP

0155-3006 Rev B_OUS EN_SILK