May 3, 2024

Johnson & Johnson to Present Scientific Data Indicating Benefits of NEW Full Visual Range IOL – TECNIS Odyssey at 2024 Annual ARVO Meeting

Other new data to be presented on Myopia Management, Cataract Surgery, and Refractive Technology

JACKSONVILLE, FL – May 3, 2024 - Johnson & Johnson^†, a global leader in eye health, will present data for the TECNIS Odyssey IOL indicating it delivers full visual range*ⁱ from distance to near and tolerance to residual refractive error as measured by defocus visual acuity. It will also present data for the TECNIS PureSee IOL**, a purely refractive presbyopia-correcting lens. Additionally, the company will present research spanning the spectrum of eye health including myopia, intraocular lenses, refractive technology and astigmatism at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting in Seattle between May 5-9, 2024.

“Of the over two billion people around the world who have vision impairment, at least one billion could have been prevented or is yet to be addressed,” said Xiao-Yu Song, Global Head of R&D, Vision, Johnson & Johnson.*** “Our global team of top-tier researchers are driven by this large unmet need and understanding of the profound impact eye health has on an individual's life. We are thrilled to share new data and uncovered insights that ultimately serve as the scientific backbone to our delivery of innovations that meet patient health needs from pediatric eyes, to developed eyes, to mature eyes.”

Research on IOL implants for cataract surgery

Cataracts affect approximately 94 million people, globally.ⁱⁱ Yet only 10-15 percent of patients are getting advanced optical IOLs, specifically designed for astigmatism and presbyopia.ⁱⁱⁱ Research presented at ARVO indicates the benefits for a new full visual range IOL*ⁱ - TECNIS Odyssey IOL as well as a refractive presbyopia- correcting extended depth of focus (EDF) IOL - TECNIS PureSee IOL**. TECNIS Odyssey is expected to be fully commercially available in the US during the second half of 2024.

Tolerance to refractive error for a new full-range spectacle independence IOL - early results. De Jesus, Melinda et al. This study evaluates the tolerance to refractive error for a new full-range spectacle independence, TECNIS Odyssey™ IOL. Early data indicate that the new TECNIS Odyssey™ IOL delivers full visual range*ⁱ from distance to near and tolerance to residual refractive error as measured by defocus visual acuity.
Clinical evaluation of tolerance to residual refractive errors following implantation with a refractive extended depth of focus (EDF) IOL.** Vilupuru, Srividhya et al. In patients implanted with PC-IOLs, even small amounts of residual errors can impact visual performance and may lead to high levels of dissatisfaction. The purpose of this study is to evaluate the tolerance to residual errors with TECNIS PureSee IOL** --- a refractive EDF IOL, and an enhanced monofocal IOL by evaluating patients’ satisfaction and distance visual performance in patients with ametropia. The study found that the optical design of TECNIS PureSee IOL** provides high tolerance to refractive errors, at the level of an aspheric monofocal IOL. Ametropic patients implanted with the TECNIS PureSee IOL** had high uncorrected distance visual acuity, did not need glasses at distance, and were highly satisfied with their distance vision.

Research on soft contact lenses for myopia management

Myopia poses the biggest eye health threat of the 21st Century,^iv with half the world’s population projected to be myopic by 2050.^v Myopia may also increase the risk of permanent vision loss due to the development of cataracts, glaucoma, retinal detachment, myopic macular degeneration, or other eye conditions.^vi New data will present research aiming to better understand myopia management, including soft contact lenses in the pediatric eye.

3-year myopia management efficacy can be predicted from 1-year data. Brennan, Noel et al. In this study the authors show that 3-year efficacy can be predicted from 1-year data, potentially obviating the

need for longer term studies. Relative efficacy of different treatments can thus be deduced by examination of 1-year data from robustly designed and conducted randomized controlled trials. The study points to implications for myopia management in clinical practice and regulatory considerations of myopia interventions.

Research on refractive lenticule procedures of ELITA Femtosecond Laser System^

Several sets of data will be presented on lenticule removal using the ELITA Femtosecond Laser System^ which will allow surgeons to perform refractive error correction on patients. The system leverages an ultra-precise laser pulse and fast laser delivery.

Evaluation of Visual Outcomes and Ease of Lenticule Removal Using A New Innovative Femtosecond Laser System.^ Gonzalez-calle, Alejandra et al. The aim of this clinical trial was to evaluate visual outcomes of the new femtosecond laser system (nFS)^ for the correction of compound myopic refractive errors. Surgeons also assessed ease of lenticule removal. The authors found that the nFS delivered consistent, safe, and effective treatment of myopic refractive errors with and without astigmatism over 12 months. Low pulse energy enabled easy lenticule removal with minimal tissue manipulation promoting fast visual recovery, and excellent visual outcomes.

Additional posters from the Vision R&D and Clinical Affairs teams of Johnson & Johnson at the ARVO 2024 Annual Meeting include:

Cataract:

Evaluation of the effect of the post-operative refractive outcomes on vision with presbyopia-correcting lenses. Alarcon, Aixa et al.
Assessment of subjective and objective perception of photic phenomena originating from intraocular lenses. Jenkins sanchez, Mark D. et al.
Theoretical Impact of Chromatic Aberration Correction on Visual Acuity. Nankivil, Derek et al.
Propensity of Intraocular Lenses to Calcify in Predictive in vitro and in vivo Models. Gray, Brad et al.
Effects of capsulorhexis size and position on post-surgical IOL alignment. Feng Liying et al.
Visual acuity measured at various chart distances versus defocus curves. Weeber, Hank A. et al. Myopia:
Subjective vision performance of soft contact lenses for myopia management in children. Nixon, Alex et al.
Assessment of off-eye power profile for a non-coaxial multi-zone soft contact lens via deflectometry and ray tracing methods. Nti, Augustine et al.
Increased prevalence of myopia in the United States between 1971-1972 and 1999-2004—A reappraisal and model. Brennan, Noel et al.

Refractive:

Creation of Ultralow Pulse Energy Corneal Lenticular Incisions with New Femtosecond Laser. Umar, Athiyya et al.
Finite Element Comparison of Biconvex and Plano-Convex Lenticule Designs for Myopic Correction. Vorhees, Andrew et al.
Detection of the uncut tissue in-situ for the lenticular refractive surgery. Rahaman, Saidur M. et al.
Comparison of Contrast Sensitivity Between One and Two Repeated Measurements After Lenticule Removal Procedure. Ying, Wang et al.
Assessment of corneal tissue interface quality for optimization of femtosecond laser SILK refractive surgery. Minoguchi, Hajime et al.
Removal of Corneal Specular Reflection with Pulsed LED Illumination. Chen, Li et al.

Additional information on the company’s commitment to transform treatment of retinal diseases at ARVO 2024 can be found here .

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^†About Vision at Johnson & Johnson

Johnson & Johnson has a deep legacy in developing transformational new products that improve the health of patients’ eyes. As a global leader in eye-health, we have a bold ambition: Vision Made Possible – and are paving the way for a new future of eye health to support the full spectrum of pediatric, developed and mature eyes.

Through cutting-edge innovation, scientific expertise, and advanced technologies, we are revolutionizing the way people see and experience the world. At every step of the eye health journey – from myopia solutions, contact lenses, refractive and cataract surgical solutions – to investigational gene therapies for retinal diseases, we stand as a trusted partner with the goal of making vision possible for customers and patients. Visit us

at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook.

^‖About Johnson & Johnson MedTech

At Johnson & Johnson MedTech, 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, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized. For more, visit https://thenext.jnjmedtech.com.

Media Contact

Janet Cheng
Vision, Johnson & Johnson
Jcheng43@its.jnj.com

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS ODYSSEY™ IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODEL DRN00V AND TECNIS ODYSSEY™ TORIC II IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODELS DRT150, DRT225, DRT300, DRT375

Rx Only INDICATIONS:

The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS Odyssey™ 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 Odyssey™ 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 Odyssey™ 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 Odyssey™ 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 Odyssey™ 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 Odyssey™ Toric II IOL. All preoperative surgical parameters are important when choosing a TECNIS Odyssey™ 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 Odyssey™ 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 Odyssey™ 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.

* According to ISO 11979-7:2024, based on the clinical study of the parent IOL
** TECNIS PureSee IOL is available in EMEA. It has not received PMA Approval in the U.S.
*** Xiao-Yu Song, MD, Ph.D. is an employee of Johnson & Johnson Vision Care, Inc.
^The ELITA Femtosecond Laser 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.

ⁱ Data on File, 2024. 2024DOF4002
ⁱⁱ World Health Organization (2022) Blindness and vision impairment.
ⁱⁱⁱ Johnson & Johnson Enterprise Business Review. December 2023
^iv JJV data on file - Myopia Compendium
^v Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology 2016;123:1036-42
^vi Haarman AEG, Enthoven CA, Tideman JWL, et al. The Complications of Myopia: A Review and Meta-Analysis. Invest Ophthalmol Vis Sci. 2020 Apr 9;61(4):49.

2024PP08719