Latest news with #presbyopia
Yahoo
7 hours ago
- Business
- Yahoo
Opus Genetics Announces VEGA-3 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
Study met its primary and key secondary endpoints, demonstrating rapid and sustained improvement in near visual acuity Safety profile consistent with previous clinical trials and no treatment-related serious adverse events reported in the study No evidence of tachyphylaxis was observed in this study over the 6-week period Management to Host Webcast and Conference Call Today at 8:00 A.M. ET RESEARCH TRIANGLE PARK, N.C., June 26, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced positive topline results from VEGA-3, its second pivotal Phase 3 trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia. Presbyopia is an ophthalmic disorder that involves the progressive loss of ability to focus on close objects that results in blurred near vision, difficulty seeing in dim light, and eye strain. The VEGA-3 trial met its primary endpoint, with a statistically significant 27.2% of participants treated with Phentolamine Ophthalmic Solution 0.75% achieving a ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA), with less than a 5-letter loss in binocular best-corrected distance visual acuity (BCDVA) at 12 hours post-dose on Day 8, compared to 11.5% of patients on placebo (p<0.0001). The trial also met key secondary efficacy endpoints, reinforcing the benefit observed. 'The results of the VEGA-3 trial reinforce our belief that Phentolamine Ophthalmic Solution 0.75% could offer an option to improve near vision for millions of adults affected by presbyopia,' said George Magrath, M.D., CEO, Opus Genetics. 'The positive results from both our Phase 3 VEGA-2 and VEGA-3 trials support the submission of an application to the U.S. Food and Drug Administration (FDA), which we plan to file in the second half of 2025. I want to thank the participants and clinical teams who participated in VEGA-3 and who have helped us bring Phentolamine Ophthalmic Solution 0.75% to this point in development.' 'These findings provide further validation of Phentolamine Ophthalmic Solution 0.75% as a differentiated approach to managing presbyopia, reflected by its ability to improve near vision while preserving distance vision without compromising low contrast vision,' said Jay Pepose, M.D., Ph.D., Chief Medical Advisor, Opus Genetics. VEGA-3 Phase 3 Study VEGA-3 is the second Phase 3 clinical trial evaluating the safety and efficacy of Phentolamine Ophthalmic Solution 0.75% in subjects with presbyopia. VEGA-3 is a multicenter, randomized, double-masked, placebo-controlled Phase 3 study that enrolled 545 participants across 40 sites in the United States. Subjects were randomized in a 3:2 ratio to receive either Phentolamine Ophthalmic Solution 0.75% or placebo, administered once daily in the evening. Top-Line Results: The primary endpoint was defined as the proportion of participants achieving a ≥15-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) improvement in binocular DCNVA and with less than 5 letters of loss in binocular BCDVA from baseline at 12 hours post-dose on Day 8, as compared to placebo. 27.2% of participants treated with Phentolamine Ophthalmic Solution 0.75% achieved a ≥15-letter improvement in DCNVA, with less than a 5-letter loss in BCDVA at 12 hours post-dose on Day 8, compared to 11.5% of patients on placebo (p<0.0001). 20.6% of patients in the Phentolamine arm achieved ≥15-letter ETDRS (≥3-line) gain in DCNVA at 1-hour post-dose on Day 1 compared to 6.1% of those receiving placebo (p=0.0002). Significant patient-reported functional benefit at Days 3 and 8 and Week 6 were observed with patients reporting satisfaction with near vision upon awakening (p<0.0001) and improvement in their near vision (p<0.0001). There was no evidence of tachyphylaxis observed after 6 weeks compared to the primary endpoint at Day 8 12 hours post-dose. Phentolamine Ophthalmic Solution 0.75% demonstrated a safety profile consistent with previous trials, with no new safety signal identified and no treatment-related serious adverse events reported in this study. The most common (≥5%) treatment-emergent adverse events included conjunctival hyperemia, instillation site irritation, and dysgeusia and all of which were predominantly mild. A low rate of headache (2.6%) was reported over the study period. VEGA-3 patients will continue to be monitored for long-term safety over 48 weeks. Additional information on the VEGA-3 study design is available on (NCT06542497). Opus Genetics and Viatris (through its affiliate) are parties to a global licensing agreement which provides for the development of Phentolamine Ophthalmic Solution 0.75% and grants exclusive rights to Viatris to commercialize Phentolamine Ophthalmic Solution 0.75% in the United States. Conference Call & Webcast Details Opus Genetics management will host a webcast and conference call today at 8:00 a.m. Eastern Time to discuss the VEGA-3 results and provide a corporate update. The live and archived webcast may be accessed on the Opus Genetics website under the Investors section: Events. The live call can be accessed by dialing 888-506-0062 (domestic) or 973-528-0011 (international) and entering conference code: 936860. Opus Genetics suggests participants join 15 minutes in advance of the event. About Phentolamine Ophthalmic Solution 0.75% Phentolamine Ophthalmic Solution 0.75% is a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size, administered as an eye drop. It works by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors, without affecting the ciliary muscle. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in two Phase 3 programs for the treatment of presbyopia and dim (mesopic) light vision disturbances after keratorefractive surgery (LYNX clinical program) and presbyopia (VEGA clinical program). About Presbyopia Presbyopia is the progressive loss of ability to focus on near objects that typically becomes noticeable in the early to mid-40s. As the eye ages, the ability to focus for reading and other tasks that require clear vision at near distances decreases. Presbyopia patients experience blurred near vision, difficulty seeing in dim light and eye strain. This ubiquitous condition leads to the widespread use of reading glasses or bifocals. It is estimated that 128 million Americans, and over 2 billion people worldwide, have presbyopia, and this number is expected to grow as the population ages. About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene and small molecule therapies for vision-threatening eye diseases. The company's pipeline features AAV-based gene therapies targeting inherited retinal diseases including Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Its lead candidate, OPGx-LCA5, is in a Phase 1/2 trial for LCA5-related mutations and has shown encouraging early results. Additional programs include OPGx-BEST1, a gene therapy targeting BEST1- related retinal degeneration and a Phase 3-ready small molecule therapy for diabetic retinopathy, developed under a Special Protocol Assessment with the FDA. Opus is also advancing Phentolamine Ophthalmic Solution 0.75%, a partnered therapy currently approved in one indication and is being studied in two Phase 3 programs for presbyopia and dim light vision disturbances. The company is based in Research Triangle Park, NC. For more information, visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to the clinical development, clinical results, and future plans for Phentolamine Ophthalmic Solution 0.75% and expectations regarding us, our business prospects, and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading 'Risk Factors' included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'aim,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts Investors Jenny KobinRemy BernardaIR Advisory Solutionsir@ MediaKimberly HaKKH Source: Opus Genetics, Inc.
Yahoo
3 days ago
- Business
- Yahoo
Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens - ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM
World's leading* contact lens brand ACUVUE brings pioneering innovation for astigmatic patients with presbyopia, providing visual clarity and comfort1 Launch reinforces Johnson & Johnson's position as world leader in contact lenses* – pushing boundaries in optical and material science JACKSONVILLE, Fla., June 23, 2025 /CNW/ -- Today, Johnson & Johnson,† a global leader in eye health, announced the launch of ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM, the first and only daily disposable contact lens for people with both astigmatism and presbyopia.2 This pioneering contact lens provides patients crisp, clear, stable vision at all distances and in all lighting conditions, along with comfort that lasts all day.1 The lens is now available in the U.S. and Canada, and the launch of ACUVUE OASYS MAX 1-Day for ASTIGMATISM is expected later this summer. Experience the full interactive Multichannel News Release here: "Building on our legacy of firsts, we are thrilled to launch ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM," said Peter Menziuso, Company Group Chairman, Vision at Johnson & Johnson.‡ "ACUVUE is the world's leading contact lens brand* and with these new products, we now have the first and only complete family of daily-disposable contact lenses.# 2 Clear sight empowers people to live their best lives, and we believe everyone should have the opportunity to achieve it. That's why we focus our innovation on areas with the greatest unmet needs for patients. Today, we are working to fulfill that promise, providing millions of patients with a differentiated ACUVUE experience." "Finally, patients with both presbyopia and astigmatism can enjoy the freedom and comfort of a daily disposable lens without compromising the quality of their vision," said Dr. Mark Wells, "This new lens was designed to help patients who struggle with multiple vision correction issues, allowing them to experience the comfort and clarity of MAX."1 Based on extensive studies, 95% of people wearing ACUVUE OASYS MAX 1-DAY MULTIFOCAL for ASTIGMATISM contact lenses reported their vision was clear during their daily activities,§ 1 while 87% saw clearly while driving at night.§ 1 Additionally, 92% of wearers said their eyes felt comfortable throughout the entire day.¶ 1 Astigmatism affects about 50% of the population,3 making it one of the most common vision conditions. It is characterized by imperfections in the curvature of the eye, leading to distorted or blurred vision. Presbyopia, commonly beginning in the early to mid-40s, is the gradual loss of near vision. Traditionally, there has been a gap for people with astigmatism when they begin to experience presbyopia. They've had to make compromises by either switching from daily contact lenses to reusables, or layering reading glasses over their contact lenses. The ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM contact lens is built with the combination of four proprietary technologies4 which enable its comfort and visual results: BLINK STABILIZED Design helps the lens stay put, so vision is not distorted or blurry when you blink or move your head.1,4 PUPIL OPTIMIZED Design helps meet presbyopic vision needs, even as you age and your vision continues to change.5 TearStable Technology helps keep the lens hydrated, facilitating end of day comfort.†† 1,6,7,8 Finally, the OptiBlue Light Filter provides 60% blue-violet light filtering, the highest in the industry.**‡‡ 7,8 Later this summer, the ACUVUE OASYS MAX 1-Day for ASTIGMATISM contact lens will launch in both the U.S. and Canada, making the ACUVUE OASYS MAX 1-Day Family of lenses the first and only complete daily disposable family of contact lenses on the market.# 2 Both ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM and ACUVUE OASYS MAX 1-Day for ASTIGMATISM are planned to be introduced in additional markets outside North America during 2025 and beyond. To learn more about ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM or to search for an eye care provider, visit †About Vision at Johnson & JohnsonJohnson & Johnson has a deep legacy in developing transformational new products that improve the health of patients' eyes. We have a bold ambition: Vision Made Possible – improving sight for more than 40 million people each year. Through cutting-edge innovation, expertise in material and optical science, and advanced technologies, we are revolutionizing the way people see and experience the world. Visit us at follow @JNJVision on Twitter, Johnson & Johnson | Vision on LinkedIn, and @JNJVision on Facebook. About Johnson & JohnsonAt 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 Follow us at @JNJMedTech and on LinkedIn. Johnson & Johnson Vision Care, Inc., a Johnson & Johnson Company. * Source Euromonitor International Limited; Eyewear 2025 edition; value sales at rsp, all retail channels, 2023 data; "ACUVUE® family of brands" represents aggregated sales of the following brands: 1-day ACUVUE®, ACUVUE® OASYS, ACUVUE® VITA®, and ACUVUE®2.‡ Peter Menziuso is an employee of Johnson & Johnson#Full/complete family consists of sphere, multifocal, toric, and multifocal toric contact lenses§ Model-adjusted percent estimate¶ T3B descriptive summaries: n=171**Filtering of HEV light by contact lenses has not been demonstrated to confer any health benefit to the user, including but not limited to retinal protection, protection from cataract progression, reduced eye strain, improved contrast, improved acuity, reduced glare, improved low light vision, or improved circadian rhythm/sleep cycle. The Eye Care Professional should be consulted for more information.††Versus ACUVUE® OASYS 1-Day, Dailies Total1®, My Day®, Infuse™ and Precision 1®.‡‡Versus publicly available information for standard daily use contact lenses as of December 2023. © Johnson & Johnson and its affiliates 2025 2025PP10152 1 JJV Data on file, 2024: Subjective Standalone Claims for ACUVUE® OASYS MAX 1-Day MULTIFOCAL Contact Lenses for ASTIGMATISM2 JJV Data on File 2025, World's First and Only Daily Disposable Multifocal Toric Contact Lens3 Young G, Sulley A & Hunt C. Prevalence of Astigmatism in Relation to Soft Contact Lens Fitting; Eye & CL, 2011: 37: 20-254 JJV Data on File: Technical Description of ACUVUE® OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM5 JJV Data on File 2020. ACUVUE OASYS MULTIFOCAL Fit and Performance Claims6 JJV Data on File 2022. Effect on Tear Film and Evaluation of Visual Artifacts with ACUVUE® OASYS MAX 1-Day Family.7 JJV Data on File 2022. JJV Data on File 2022 TearStable™ Technology Definition.8 JJV Data on File 2022. Material Properties: 1-DAY ACUVUE® MOIST, 1-DAY ACUVUE® TruEye®, ACUVUE® OASYS 1-Day with HydraLuxe® Technology and ACUVUE® OASYS MAX 1-Day with TearStable™ Technology Brand Contact Lenses and other daily disposable contact lens brands. Important information for contact lens wearers: ACUVUE Contact Lenses are available by prescription only for vision correction. An eye care professional will determine whether contact lenses are right for you. Although rare, serious eye problems can develop while wearing contact lenses. To help avoid these problems, follow the wear and replacement schedule and the lens care instructions provided by your eye doctor. Do not wear contact lenses if you have an eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. If one of these conditions occurs, remove the lens and contact your eye doctor immediately. For more information on proper wear, care and safety, talk to your eye care professional, call 1-800-843-2020, or download the Patient Instruction Guides. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the launch of ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM and ACUVUE OASYS MAX 1-Day for ASTIGMATISM contact lenses. 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. 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 most recent Annual Report on Form 10-K, 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 or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments Media ContactErin FarleyEfarley1@ Kristyna Muñozkmunoz1@ Investor Contact:Sandra Eastonseaston@ View original content: SOURCE Johnson & Johnson View original content:
Yahoo
4 days ago
- Automotive
- Yahoo
Little-known hazard sparks warning for Aussie drivers over 40: 'Can affect anyone'
Sydney woman Belinda Garvanovich used to dread driving after dark. For years, the anxiety persisted — until it led to a frightening close call. "I used to refuse driving long distances at night and would make my husband drive as I wasn't confident," the 52-year-old told Yahoo News Australia. "I pushed my kids to get their licence as soon as they could so they could drive at night and not me. "One time at a carpark at night, I couldn't see properly and went into a pole… next weekend I had an appointment booked in with my optometrist," she said. The cause? Presbyopia, a common and age-related vision condition that affects the ability to focus on close-up objects, and one that millions of Australians may have without realising. Belinda now wears "night glasses" while on the road and urged others with impaired vision to follow suit. "Don't put it off like me and get it checked ASAP," she urged. After Australians experienced the longest night of the year this weekend, new research suggests a potentially dangerous trend is playing out on our roads, particularly among Aussies aged 35 to 50. According to a new study, a staggering 72 per cent of mid-life Australians have never heard of presbyopia, despite more than half (51 per cent) reporting close-up vision problems in everyday life. The condition, which typically begins around age 40, becomes especially problematic during night driving. Optometrist Greeshma Patel said the numbers reflect a broader lack of awareness and a pressing safety issue. "Presbyopia can affect nearly everyone as they age… but the term itself isn't widely known," she explained. "People often attribute their blurry near vision to just 'getting older' or 'tired eyes' rather than a specific condition." Millions warned as new cameras officially target drivers from today Millions warned as change speed cameras becomes official Urgent warning over deadly trend on Aussie roads She said the condition can have serious implications on the road, especially in low-light conditions. "When your eyes struggle to focus on near objects, it also affects their ability to quickly adapt focus between different distances," she said. "This means a driver might find it difficult to clearly read the dashboard, then instantly switch focus to road signs in the distance, or to spot pedestrians on dimly lit streets. It's not just about reading a book — it's about safe driving." According to the survey, conducted by Specsavers, some 38 per cent of mid-life Australians admit to erratic driving at night due to poor vision. Pight per cent said they'd had a car accident as a result, and 57 per cent have felt unsafe driving at night due to their vision Patel said symptoms like holding your phone further away, struggling with small text, or needing brighter light to read can all point to presbyopia, but many brush it off until something goes wrong. "Workarounds like increasing screen text or borrowing someone else's glasses may help short term, but they delay getting the proper treatment," she said. Fortunately, the fix is simple. "Presbyopia is very easy to treat and manage," she said. "The most common solutions are reading glasses, bifocals or multifocal lenses, and there are also contact lenses or corrective surgery options." She's calling for greater public awareness, including campaigns to normalise routine eye checks. "Eye tests are bulk billed with a valid Medicare card, but many people still don't prioritise them unless something is seriously wrong," she said. As Australia continues to grapple with a national rise in road deaths, vision may be one of the most overlooked risk factors, especially in the colder, darker months. "Mid-life vision issues aren't just about reading or texting," Patel said. "They're directly tied to confidence and clarity behind the wheel. A quick eye test could prevent a crash — or even save a life." Do you have a story tip? Email: newsroomau@ You can also follow us on Facebook, Instagram, TikTok, Twitter and YouTube.
Yahoo
17-06-2025
- Business
- Yahoo
Johnson & Johnson Launches New TECNIS Odyssey Next-Generation Intraocular Lens in Europe, the Middle East, and Canada Offering Cataract Patients Precise Vision at Every Distance in Any Lighting*†‡1,6
The new full visual range*1 IOL enables 93% of patients to become free from glasses at all distances.**2 *** With best-in-class image contrast and low-light performance,#~3,4,5 TECNIS Odyssey IOL expands the Johnson & Johnson portfolio of advanced Presbyopia Correction IOLs. TECNIS Odyssey IOL enables surgeons to deliver consistent and reliable patient outcomes.∫7,15 This content is intended for Healthcare Professionals only, not for the general public. JACKSONVILLE, Fla., June 17, 2025 /CNW/ -- Johnson & Johnson,§ a global leader in eye health, announced today that it is expanding its portfolio of presbyopia-correcting intraocular lenses (PC - IOL) with the roll-out of TECNIS Odyssey IOL in Europe, the Middle East, and Canada. The new full visual range*1 IOL offers high-quality and continuous vision with unmatched range.$6,16 This will allow patients to see clearly from far to near and in between, minimizing their need for glasses.‡+2,6,7 Built on the industry-leading TECNIS platform, combining advanced optics and proprietary materials, TECNIS Odyssey IOL offers consistently clear, high-contrast vision. "TECNIS Odyssey IOL is the fastest growing PC-IOL in the United States,^ and we are excited to be making it available to more patients around the world. It addresses a significant unmet need for cataract patients seeking greater spectacle independence.+ Now – together with TECNIS PureSee – TECNIS Odyssey IOL elevates the strength and depth of our global IOL portfolio, meeting the diverse needs of today's aging population," said Peter Menziuso, Company Group Chairman, Vision, Johnson & Johnson. Currently, an estimated 94 million people aged 50 years and over have moderate-to-severe distance vision impairment or blindness that could be corrected through lens replacement surgery.8 These figures are projected to increase, since presbyopia and cataract development are part of the aging process. Presbyopia is a progressive eye condition that makes it difficult to focus on close objects and usually becomes noticeable around 40 years of age.9 Full visual range IOLs provide the opportunity to correct presbyopia at the time of lens replacement surgery. "From my early experience, what sets the TECNIS Odyssey IOL apart, is its ability to deliver consistent visual outcomes across a wide range of patients, due to its advanced design with higher tolerance to residual refractive error,"∫7,11 said Professor Beatrice Cochener-Lamard, Head of the Ophthalmology Department at Brest University Hospital in France.^^^ TECNIS Odyssey IOL is the latest innovation for those seeking greater visual freedom – offering: Precise vision: TECNIS Odyssey IOL provides crisp and clear vision, allowing patients to see with clarity at every distance6 - whether they are reading, driving or engaging in daily activities. 94% of patients were satisfied with their overall vision without glasses.&****12 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 tablet,&****13 and 97% were satisfied with distance vision.&****12 In any lighting: Engineered to minimize night vision disturbances – fewer halos and glare#14 – TECNIS Odyssey IOL provides better image quality than PanOptix day and night,##3,4,5 for a more comfortable night-time experience. 92% of patients were satisfied with their ability to see steps and read street signs at night.&****13 With a variety of options for different visual needs and lifestyles, the TECNIS platform empowers more patients to find the right solution. The Johnson & Johnson portfolio of advanced Presbyopia Correction IOLs available in Europe, the Middle East, Canada, and Japan now includes both TECNIS Odyssey IOL and TECNIS PureSee IOL. TECNIS Odyssey IOL, the full range of vision IOL, is also available in the US, Puerto Rico, and Japan. TECNIS PureSee IOL, the purely refractive, extended depth of focus IOL, is also available across APAC and Latin America. TECNIS PureSee has not received PMA Approval in the U.S. For more patient information and tools please visit Visit us at and and follow Johnson & Johnson | Vision on LinkedIn. About Vision at Johnson & JohnsonJohnson & Johnson has a deep legacy in developing transformational new products that improve the health of patients' eyes. We have a bold ambition: Vision Made Possible – improving sight for more than 40 million people each year. Through cutting-edge innovation, expertise in material and optical science, and advanced technologies, we are revolutionizing the way people see and experience the world. Visit us at follow @JNJVision on Twitter, Johnson & Johnson | Vision on LinkedIn, and @JNJVision on Facebook. About Johnson & JohnsonAt 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, orthopedics, surgery and vision solutions at Follow us at @JNJMedTech and on LinkedIn. Johnson & Johnson Surgical Vision, Inc. is part of Johnson & Johnson. Cautions Concerning Forward-Looking StatementsThis 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. 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 most recent Annual Report on Form 10-K, 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 or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Footnotes*According to ISO 11979-7:2024, based on the clinical study of the parent IOL **(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); ***Based on 1-month postoperative data from a multicenter, retrospective, real-world clinical study in the U.S. evaluating visual and patient-reported outcomes from subjects bilaterally implanted with TECNIS Odyssey™ IOL (n=96).****Based on 3-month postoperative data from a multicenter, observational clinical study in the U.S. evaluating visual and patient-reported outcomes from subjects bilaterally implanted with TECNIS Odyssey™ IOL (n=33). ¶based on pre-clinical bench testing. The third-party trademarks used herein are the trademarks of their respective owners. ∫compared to TECNIS Synergy™ and TECNIS™ Multifocal IOLs based on pre-clinical bench testing #compared to PanOptix® based on pre-clinical bench testing ##compared to leading competitor full visual range IOLs based on pre-clinical bench testing (white light MTF at 50 c/mm measured for 3mm & 5mm pupil in the ACE model) §Johnson & Johnson represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both. †continuous 20/25 or better ‡based on pre-clinical bench testing ^based on Market Scope's estimated procedure for 2024 vs 2023 ^^^Professor Beatrice Cochener-Lamard is a paid consultant of Johnson & Johnson MedTech ~Compared to TECNIS SYNERGY™ based on bench testing +Individual results will vary. Some TECNIS Odyssey™ IOL patients may require spectacles post-surgery. -Results may vary. Consult your doctor to determine the lens options that are right for you. $Compared to PanOptix® based on bench testing and head-to-head clinical studies of parent lens &Values rounded to the nearest 1% Indication and safety information in regions where these products are available for use is included below. Please note indications may differ based on region. Full safety information is available hyperlinked below. IN THE UNITED KINGDOM The promoted product is a medical device. For healthcare professionals only. Please reference the Instructions for Use for a complete list of Indications and Important Safety Information and contact our specialists in case of any question. IN CANADA 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 DRT100, DRT150, DRT225, DRT300, DRT375, IN CANADA: Rx Only INDICATIONS FOR USE: 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 or without presbyopia, 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 which are indicated for primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with or without presbyopia, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing vision far through near and reduced spectacle dependence across a range of distances. The lens is intended to be placed in the capsular bag. 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 the possibility of visual effects (such as halo or glare), in nighttime or poor visibility conditions. Patients may perceive these visual effects as an annoyance or hindrance, which, on rare occasions, may be significant enough for the patient to request removal of the IOL. 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 potential spectacle independence. 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. Care should be taken to achieve centration of the toric IOL. Safety and effectiveness in patients 21 years or younger have not been established in clinical studies. ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS PURESEE™ IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, AND TECNIS PURESEE™ TORIC II IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM IN CANADA INDICATIONS FOR USE The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ IOL which is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of preexisting corneal astigmatism, in whom a cataractous lens has been removed. The lens is intended to correct presbyopia by providing improved vision over a continuous range of distances including far, intermediate, and near, and decreased spectacle dependence. The lens is intended for capsular bag placement only. The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS PureSee™ Toric II IOL which is indicated for primary implantation for the visual correction of aphakia and pre-existing corneal astigmatism in adult patients with and without presbyopia in whom a cataractous lens has been removed. The lens is intended to correct presbyopia by providing improved vision over a continuous range of distances including far, intermediate, and near, a reduction of residual refractive cylinder, and decreased spectacle dependence. The lens is intended for capsular bag placement only. WARNING Physicians should weigh the potential risk/benefit ratio of IOL implantation in patients with any of the conditions described in the Directions for Use. These conditions are not specific to the design of the IOL and are attributed to cataract surgery and/or IOL implantation in general. The IOL should be placed entirely in the capsular bag. Do not place the IOL in the ciliary sulcus. Patients should be informed of the possibility of visual disturbances. The lens may cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully inform the patient of this risk before implanting the lens. Special consideration should be made for patients with macular disease, amblyopia, corneal irregularities, or other ocular disease. Inform patients to exercise special caution when driving at night or in poor visibility conditions. Rotation of the TECNIS PureSee™ Toric II IOL away from their intended axis can reduce their astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, IOL repositioning should occur as early as possible prior to lens encapsulation. 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. Do not use if the cartridge tip is cracked or split. Do not implant the IOL if the rod tip does not advance the IOL or if it is jammed in the delivery system. Do not advance the IOL from the Holding Position (located at the half turn rotation position for the initial advancement of the IOL into the cartridge) prior to fully hydrating the system and ready for implantation. A minimum of 1 minute at the Holding Position is required to fully hydrate the system to prevent sticking and a potential scratch or crack to the IOL. Interruptions during delivery may result in the IOL being scratched or cracked or stuck in the cartridge. Discard the device if the IOL has been advanced past the Holding Position but not delivered within 60 seconds. The IOL and delivery system should be discarded if the IOL has been folded within the cartridge for more than 10 minutes. Not doing so may result in the IOL being stuck in the cartridge. PRECAUTIONS Autorefractors may not provide optimal postoperative refraction of patients with the IOL. Manual refraction with maximum plus technique is strongly recommended. Recent contact lens usage may affect the patient's refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Target emmetropia for optimum visual performance. For the TECNIS PureSee™ Toric II IOL, variability in any preoperative surgical parameters (e.g., keratometric cylinder, incision location, estimated surgically induced astigmatism, or biometry) can influence patient outcomes. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case, to avoid lens rotation. This is a single use device, do not resterilize the lens or the delivery system. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the delivery system. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C (63°F). The use of balanced salt solution or viscoelastics is required when using the delivery system. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. ADVERSE EVENTS Potential adverse events during or following cataract surgery with implantation of the IOL may include but are not limited to: Endophthalmitis/intraocular infection, IOL dislocation, persistent cystoid macular edema, persistent corneal stromal edema, persistent raised intraocular pressure (IOP) requiring treatment, secondary surgical intervention (including implant repositioning, removal, AC tap, or other surgical procedure). Adverse events can lead to permanent visual impairment and may require secondary surgical intervention, including intraocular lens exchange or explanation. ATTENTION Reference the Directions for Use for a complete listing of Indications and Important Safety Information. IN THE UNITED STATES 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 IN THE UNITED STATES 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 found here: -------------------------------------------------1 Data on File. 2024DOF4002 (prospective, multicenter, randomized, three-way-masked clinical study comparing subjectsbilaterally implanted with TECNIS Synergy IOL (n=132) vs TECNIS 1-Piece Monofocal IOL (n=131) at 6-months post-op) 2 Data on File. DOF2023CT4051. 3 Data on File. 2024DOF4033 4 Data on File. DOF2019OTH4002 5 Data on File. DOF2023CT4007 6 Data on File. DOF2023CT4023 7 Data on File. 2024DOF4003 8 World report on vision. Geneva: World Health Organization, 2019. Available at: Last accessed: May 2025. 9 What Is Presbyopia – American Academy of Ophthalmology. Access from: 2024REF5075. 11 Data on File. 2024DOF4017 12 Data on File. 2024DOF4027. 13 Data on File. 2024DOF4029. 14 Data on File. 2024DOF4005 15 DOF2023CT4052 16 DOF2020CT4014 Media contact (EMEA): Sarah Smithssmith49@ Media contact (NA): Maggie Lorenzmloren15@ Investor contact:Sandra Eastoninvestor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson Medical Devices Companies View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
