JNJ Johnson and Johnson

The new full visual range IOL*¹ delivers exceptional distance vision² and 14% smaller readable print size vs PanOptix^{3 †}.

93% of patients become free from glasses at all distances.^{#4 ‡}

TECNIS Odyssey IOL offers higher tolerance to residual refractive errors, enabling surgeons to deliver consistent and reliable patient outcomes.⁵

JACKSONVILLE, Fla., Sept. 30, 2024 /PRNewswire/ -- Johnson & Johnson^§, a global leader in eye health, has announced it's expanding the roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC - IOL), TECNIS Odyssey, in the U.S. The new full visual range IOL*¹ offers patients unmatched continuous full range of vision^‖6, so they can see clearly from far to near and in between, minimizing their need for glasses ^{3,6 †‖#} . TECNIS Odyssey IOL is built on the TECNIS platform, providing two-times better contrast in low lighting than PanOptix.^{7,8 †} In addition, TECNIS Odyssey IOL patients are able to read 14% smaller print on average than PanOptix IOL patients^{2 †} and 93% reported no or mild halos, glare, or starbursts one month after surgery⁹.

Experience the full interactive Multichannel News Release here: https://www2.multivu.com/johnson-johnson/9293351-en-johnson-and-johnson-vision-tecnis-odyssey

"More than 14,000 eyes have already benefited from TECNIS Odyssey, our new full visual range IOL¹. TECNIS Odyssey patients have reported outstanding visual outcomes following surgery, which is why we are excited to announce we are expanding the roll-out across the U.S. today," said Peter Menziuso^♠, Company Group Chairman, Vision, Johnson & Johnson. "Cataract surgery gives patients a once in a lifetime opportunity to improve their sight, and now with this advanced IOL, patients can see clearly at every distance, without the need for glasses."

It is estimated that 20.5 million (17.2%) Americans aged 40 years and older have a cataract in one or both eyes, yet only 6.1 million (5.1%) have had cataract surgery.¹⁰ Left untreated, cataracts cause vision to deteriorate over time. Many people who have cataracts experience other problems with their vision, such as presbyopia, which is a progressive eye condition that makes it difficult to focus on close objects and usually becomes noticeable around 40 years of age.¹¹ Full visual range IOLs provide the opportunity to correct presbyopia at the time of cataract surgery.

"The TECNIS Odyssey IOL is perhaps the most comprehensive and well-balanced PC-IOL on the market to date," said Dr. George O. Waring IV**, Medical Director of the Waring Vision Institute in Mt. Pleasant, SC. "It falls under a new standard of full vision range that provides extraordinary contrast in both day and night-time conditions, tolerance to refractive error and minimal dysphotopsias with outstanding contrast sensitivity** that really takes it to a whole different level and nothing like we've seen before with prior PC-IOLs".

The new TECNIS Odyssey full visual range IOL*¹ was built with proprietary technology that results in superior image quality, delivering sharp vision even in challenging lighting conditions^{7 ,8 ††‡‡}. The design also delivers fewer visual disturbances for enhanced night-time visual quality¹²:

• Precise vision: TECNIS Odyssey IOL ensures crisp and clear vision, allowing patients to see with clarity at every distance - whether they are reading, driving or engaging in daily activities.^{6 ,7 ,8 *†‖}
• • 94% of patients were satisfied with their overall vision without glasses.

• At every distance: Its unique, freeform diffractive surface was designed to eliminate the gaps between near, intermediate and far distances, and offer continuous, uninterrupted vision at all distances.^{6 †‖}
• • 96% of patients were satisfied with reading a smartphone or tablet¹⁴, and 97% were satisfied with distance vision.¹³

• In any lighting: Engineered to minimize night vision disturbances – fewer halos and glare¹²  TECNIS Odyssey IOL provides better image quality than PanOptix day and night, for a more comfortable night-time experience^{7,8 ††‡‡}.
• • 92% of patients were satisfied with their ability to see steps at night¹⁴ and read street signs at night ¹⁴.

As part of this roll-out, J&J is launching "TECNIS Odyssey IOL Peer Connect". This initiative was designed to foster direct and meaningful medical and scientific conversations regarding TECNIS Odyssey IOL between healthcare professionals with expert surgeons who had early access to the technology. To access this interactive platform, and engage in live virtual clinical discussions, eye care professionals can request access here.

TECNIS Odyssey IOL has also received regulatory authority approval in Japan, EU, Korea, Canada, Singapore, Australia and New Zealand.^§§

For more patient information and tools please visit www.clearvisionforyou.com and access the Vision Simulator which provides valuable insights into cataract surgery and treatment options. Eye care professionals can request more information here: TECNISOdysseyIOL.com.

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 contact lenses and 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
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn.

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.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the launch of TECNIS Odyssey intraocular lens. 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., Johnson & Johnson Vision Care, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: 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 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other 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. None of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc. nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.

©Johnson & Johnson and its affiliates 2024. All rights reserved.
Third party trademarks are the property of their respective owners.

*According to ISO 11979-7:2024, based on the clinical study of the parent IOL
† Based on pre-clinical bench testing

‡ (n=82) 1-month results. Q: "Was the patient wearing any spectacles or contact lenses since the surgery?" Six subjects 6/82 (5 subjects for near, 1 subject for both distance and near)
Compared to TECNIS Synergy™ and TECNIS™ Multifocal IOLs based on pre-clinical bench testing
‖ Continuous 20/25 or better.
# Individual results will vary. Some TECNIS Odyssey™ patients may require spectacles post-surgery.
♠ Peter Menziuso is employed by Johnson & Johnson.
** George Waring is a paid consultant of Johnson & Johnson Vision, Inc. For Contrast Sensitivity support, see References section⁵.
†† Data on File. 2024DOF4003.
‡‡ Data on File. DOF2023CT4052.
 Compared to a leading competitor trifocal IOL based on pre-clinical bench testing
§§ TECNIS Odyssey IOL will be available for select surgeons in countries across Japan, Korea, Canada, Singapore, Australia, New Zealand, Europe, Middle East & Africa (EMEA) through the LMR period, with expanded roll out expected in 2025 and beyond.
§ Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.

References

¹ Data on File. 2024DOF4002
² Data on File. DOF2023CT4049
³ Data on File. DOF2023CT4056
⁴ Data on File. DOF2023CT4051
⁵ Data on File. 2024DOF4003
⁶ Data on File. DOF2023CT4023
⁷ Data on File. DOF2019OTH4002
⁸ Data on File. DOF2023CT4007
⁹ Data on File. DOF2023CT4050
¹⁰ CDC About Common Eye Disorders & Diseases (2024). Access from: https://www.cdc.gov/vision-health/about-eye-disorders/
¹¹ American Academy of Ophthalmology (2024) Access from: https://www.aao.org/eye-health/diseases/what-is-presbyopia
¹² Data on File. 2024DOF4005
¹³ Data on File. 2024DOF4027
¹⁴ Data on File. 2024DOF4029
¹⁵ DFU for TECNIS Odyssey IOL; Data on File 2024DOF4030 (comparison of binocular, mesopic contrast sensitivity without-glare results from two bilateral implantation studies: 3-month post-op, ambispective, multicenter, observational clinical study of (n= 27) TECNIS Odyssey IOL and a 1-month post-op, prospective, multicenter, randomized, double-masked clinical study of (n=135) the parent IOL and (n=137) TECNIS Monofocal IOL)

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SOURCE Johnson & Johnson