Latest news with #DavidEndicott
Yahoo
6 days ago
- Business
- Yahoo
Alcon Announces FDA Approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease
In pivotal Phase 3 trials, TRYPTYR demonstrated rapid natural tear production as early as Day 11-2 TRYPTYR is a first-in-class TRPM8 receptor agonist that rapidly stimulates natural tear production in patients with Dry Eye Disease (DED)3 Approximately 38 million individuals in the U.S. are living with DED, yet less than 10% of diagnosed patients are being treated with a prescription product4 Ad hoc announcement pursuant to Art. 53 LR GENEVA, May 28, 2025--(BUSINESS WIRE)--Regulatory News: Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced the U.S. Food and Drug Administration (FDA) has approved TRYPTYR® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED).3 TRYPTYR is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production.3 DED is a complex, multifactorial condition driven by a deficiency in natural tears, whether due to decreased tear production or increased tear evaporation.5-7 Many commonly used DED treatment options have limitations, including slow onset, patient dissatisfaction and poor adherence.8-14 Among surveyed dry eye patients, only 13% felt their dry eye was well managed.14* "Today marks a tremendous milestone for Alcon as TRYPTYR becomes our first prescription pharmaceutical treatment to be approved by the FDA since becoming an independent, publicly traded eye care company," said David Endicott, CEO of Alcon. "We look forward to making this new treatment available to millions of patients affected by Dry Eye Disease. We believe TRYPTYR is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy." This approval is supported by two Phase 3 clinical trials evaluating more than 930 patients (randomized 1:1 to TRYPTYR or vehicle) with a history of DED.1-2 In COMET-2 and COMET-3, up to four times more TRYPTYR patients experienced at least a 10mm increase in natural tear production at Day 14, compared to vehicle, 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 (both p<0.0001).1-2 Consistent results were observed at all timepoints through Day 90. TRYPTYR demonstrated statistically significant natural tear production as early as Day 1.1-2 "Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options," said Marjan Farid, MD, Professor of Ophthalmology at the University of California, Irvine. "TRYPTYR is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of Dry Eye Disease." Studies in animals suggest that acoltremon, the active substance in TRYPTYR, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for TRYPTYR in DED is unknown. TRYPTYR is available in easy-to-use, single dose vials: one drop per eye, two times a day.3 Alcon expects to launch TRYPTYR in the U.S. in the third quarter of 2025 and anticipates bringing TRYPTYR to other markets in the future. INDICATIONS AND USAGETRYPTYR (acoltremon ophthalmic solution) 0.003% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). IMPORTANT SAFETY INFORMATIONWarnings and PrecautionsPotential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces. Use with Contact Lenses: TRYPTYR should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of TRYPTYR. Adverse ReactionsIn clinical trials, the most common adverse reaction was instillation site pain (50%). Please click here for the TRYPTYR Full Prescribing Information. Forward-looking Statements This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "commitment," "look forward," "maintain," "plan," "goal," "seek," "target," "assume," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise. About Dry Eye Dry Eye Disease (DED) is one of the most common ocular surface disorders, affecting an estimated 38 million adults in the U.S. and an estimated 719 million more adults globally.4 While once considered a disease of aging populations, modern advancements, such as prolonged digital screen time, have contributed to a significant rise in DED across age and gender.15 Many existing prescription options for DED are generally regarded by many Eye Care Professionals and patients as inadequate due to low treatment efficacy, slow onset of action and/or poor tolerability.16 About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at References *Based on an online survey conducted by Chronic Dry Eye from February to April 2021 among 415 responders who reported being diagnosed with chronic dry eye. 44% reported a severe level of chronic dry eye (i.e., levels 3 and 4). Data on File for COMET-2 Phase 3 Study. Alcon 2025. Data on File for COMET-3 Phase 3 Study. Alcon 2025. TRYPTYR® U.S. FDA Prescribing Information. 2025. 2023 Dry Eye Products Markets Report, Market Scope, 2023. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017;15(3):276-283. doi: 10.1016/ Nattinen J, Aapola U, Nukareddy P, Uusitalo H. Looking deeper into ocular surface health: an introduction to clinical tear proteomics analysis. Acta Ophthalmol. 2022;100:486-498. doi: 10.1111/aos.15059. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15:438-510. doi: 10.1016/ Wilson SE, Perry HD. Long-term resolution of chronic dry eye symptoms and signs after topical cyclosporine treatment. Ophthalmology. 2007;114(1):76-79. doi: 10.1016/ Semba CP, Gadek TR. Development of lifitegrast: a novel T-cell inhibitor for the treatment of dry eye disease. Clin Ophthalmol. 2016;10:1083-1094. doi: 10.2147/OPTH.S110557. Restasis. Prescribing Information. Allergan; 2012. Accessed July 8, 2024. Hovanesian JA, Nichols KK, Jackson M, et al. Real-world experience with lifitegrast ophthalmic solution (Xiidra®) in the U.S. and Canada: retrospective study of patient characteristics, treatment patterns, and clinical effectiveness in 600 patients with dry eye disease. Clin Ophthalmol. 2021;15:1041-1054. doi: 10.2147/OPTH.S296510. Cook N, Mullins A, Gautam R, et al. Evaluating patient experiences in dry eye disease through social media listening research. Ophthalmol Ther. 2019;8(3):407-420. doi: 10.1007/s40123-019-0188. Mbagwu M, LaPrise A, Harris J, Nair AA, Fain J, Harrison DJ. Characterization of discontinuation and switching patterns of dry eye disease medications using linked EHR registry and claims data. Presented at: American Society for Cataract and Refractive Surgery Conference; April 5-6, 2024; Boston, MA. Morse H, Henneberger S, Reed J, et al. 2021 in American survey findings: living with chronic dry eye. ChronicDryEye. August 10, 2021. Accessed September 23, 2024. The Relationship Between Dry Eye Disease and Digital Screen Use - PMC ( Improved Dry Eye Drugs for 2022 and Beyond; Connect with us onFacebook LinkedIn View source version on Contacts Investor Relations Daniel CravensAllen Trang+ 41 589 112 110 (Geneva)+ 1 817 615 2789 (Fort Worth) Media Relations Steven Smith+ 41 589 112 111 (Geneva)+ 1 817 615 2666 (Fort Worth)
Business Wire
6 days ago
- Health
- Business Wire
Alcon Announces FDA Approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease
GENEVA--(BUSINESS WIRE)--Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced the U.S. Food and Drug Administration (FDA) has approved TRYPTYR ® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED). 3 TRYPTYR is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. 3 DED is a complex, multifactorial condition driven by a deficiency in natural tears, whether due to decreased tear production or increased tear evaporation. 5-7 Many commonly used DED treatment options have limitations, including slow onset, patient dissatisfaction and poor adherence. 8-14 Among surveyed dry eye patients, only 13% felt their dry eye was well managed. 14* 'Today marks a tremendous milestone for Alcon as TRYPTYR becomes our first prescription pharmaceutical treatment to be approved by the FDA since becoming an independent, publicly traded eye care company,' said David Endicott, CEO of Alcon. 'We look forward to making this new treatment available to millions of patients affected by Dry Eye Disease. We believe TRYPTYR is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy.' This approval is supported by two Phase 3 clinical trials evaluating more than 930 patients (randomized 1:1 to TRYPTYR or vehicle) with a history of DED. 1-2 In COMET-2 and COMET-3, up to four times more TRYPTYR patients experienced at least a 10mm increase in natural tear production at Day 14, compared to vehicle, 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 (both p<0.0001). 1-2 Consistent results were observed at all timepoints through Day 90. TRYPTYR demonstrated statistically significant natural tear production as early as Day 1. 1-2 'Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,' said Marjan Farid, MD, Professor of Ophthalmology at the University of California, Irvine. 'TRYPTYR is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of Dry Eye Disease.' Studies in animals suggest that acoltremon, the active substance in TRYPTYR, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for TRYPTYR in DED is unknown. TRYPTYR is available in easy-to-use, single dose vials: one drop per eye, two times a day. 3 Alcon expects to launch TRYPTYR in the U.S. in the third quarter of 2025 and anticipates bringing TRYPTYR to other markets in the future. INDICATIONS AND USAGE TRYPTYR (acoltremon ophthalmic solution) 0.003% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). IMPORTANT SAFETY INFORMATION Warnings and Precautions Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces. Use with Contact Lenses: TRYPTYR should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of TRYPTYR. Adverse Reactions In clinical trials, the most common adverse reaction was instillation site pain (50%). Please click here for the TRYPTYR Full Prescribing Information. Forward-looking Statements This press release contains 'forward-looking statements' within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'anticipate,' 'intend,' 'commitment,' 'look forward,' 'maintain,' 'plan,' 'goal,' 'seek,' 'target,' 'assume,' 'believe,' 'project,' 'estimate,' 'expect,' 'strategy,' 'future,' 'likely,' 'may,' 'should,' 'will' and similar references to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise. About Dry Eye Dry Eye Disease (DED) is one of the most common ocular surface disorders, affecting an estimated 38 million adults in the U.S. and an estimated 719 million more adults globally. 4 While once considered a disease of aging populations, modern advancements, such as prolonged digital screen time, have contributed to a significant rise in DED across age and gender. 15 Many existing prescription options for DED are generally regarded by many Eye Care Professionals and patients as inadequate due to low treatment efficacy, slow onset of action and/or poor tolerability. 16 About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at References *Based on an online survey conducted by Chronic Dry Eye from February to April 2021 among 415 responders who reported being diagnosed with chronic dry eye. 44% reported a severe level of chronic dry eye (i.e., levels 3 and 4). Data on File for COMET-2 Phase 3 Study. Alcon 2025. Data on File for COMET-3 Phase 3 Study. Alcon 2025. TRYPTYR ® U.S. FDA Prescribing Information. 2025. 2023 Dry Eye Products Markets Report, Market Scope, 2023. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017;15(3):276-283. doi: 10.1016/ Nattinen J, Aapola U, Nukareddy P, Uusitalo H. Looking deeper into ocular surface health: an introduction to clinical tear proteomics analysis. Acta Ophthalmol. 2022;100:486-498. doi: 10.1111/aos.15059. Bron AJ, de Paiva CS, Chauhan SK, et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017;15:438-510. doi: 10.1016/ Wilson SE, Perry HD. Long-term resolution of chronic dry eye symptoms and signs after topical cyclosporine treatment. Ophthalmology. 2007;114(1):76-79. doi: 10.1016/ Semba CP, Gadek TR. Development of lifitegrast: a novel T-cell inhibitor for the treatment of dry eye disease. Clin Ophthalmol. 2016;10:1083-1094. doi: 10.2147/OPTH.S110557. Restasis. Prescribing Information. Allergan; 2012. Accessed July 8, 2024. Hovanesian JA, Nichols KK, Jackson M, et al. Real-world experience with lifitegrast ophthalmic solution (Xiidra ®) in the U.S. and Canada: retrospective study of patient characteristics, treatment patterns, and clinical effectiveness in 600 patients with dry eye disease. Clin Ophthalmol. 2021;15:1041-1054. doi: 10.2147/OPTH.S296510. Cook N, Mullins A, Gautam R, et al. Evaluating patient experiences in dry eye disease through social media listening research. Ophthalmol Ther. 2019;8(3):407-420. doi: 10.1007/s40123-019-0188. Mbagwu M, LaPrise A, Harris J, Nair AA, Fain J, Harrison DJ. Characterization of discontinuation and switching patterns of dry eye disease medications using linked EHR registry and claims data. Presented at: American Society for Cataract and Refractive Surgery Conference; April 5-6, 2024; Boston, MA. Morse H, Henneberger S, Reed J, et al. 2021 in American survey findings: living with chronic dry eye. ChronicDryEye. August 10, 2021. Accessed September 23, 2024. The Relationship Between Dry Eye Disease and Digital Screen Use - PMC ( Improved Dry Eye Drugs for 2022 and Beyond;
Business Wire
25-04-2025
- Business
- Business Wire
Alcon Elevates Vitreoretinal and Cataract Surgery for Superior Efficiency* with UNITY VCS and UNITY CS
GENEVA--(BUSINESS WIRE)--Alcon, the global leader in eye care dedicated to helping people see brilliantly, today announced the launch of the UNITY ® Vitreoretinal Cataract System (VCS) and UNITY ® Cataract System (CS). The new, versatile platform offers two configurations, a combined console (VCS) as well as a standalone cataract system (CS). This platform is designed to deliver superior efficiency for vitreoretinal and cataract surgery, while enabling exceptional outcomes for patients. 2,4-6,* The systems feature many first-to-market technologies designed to deliver transformative surgical innovation for cataract and vitreoretinal surgery, including UNITY 4D Phaco, HYPERVIT ® 30K and the advanced UNITY Intelligent Fluidics system. 1,4-7 With UNITY VCS/CS, surgeons can operate at more physiologic conditions without compromising efficiency. 1 Surgeons will have the opportunity for hands on experience with UNITY VCS/CS during the 2025 American Society for Cataract and Refractive Surgeons annual meeting (ASCRS, Los Angeles, April 25-28) at the Alcon Booth (#1815). 'Alcon has a long legacy of advancing phaco and vitreoretinal technology for surgical ophthalmology. With UNITY VCS/CS, we are introducing more than a dozen innovations designed to transform surgical outcomes while delivering significant efficiencies for surgery centers across the globe,' said David Endicott, CEO of Alcon. 'This tremendous accomplishment could not have been achieved without those who participated in the development process, including the surgeons who have been evaluating the machines in their practices over the last year. We are excited to start shipping inventory next month so more practices can experience this extraordinary innovation.' The combination vitreoretinal and cataract system intelligently transforms vitreoretinal and cataract surgery with significant innovation. With the introduction of UNITY Intelligent Fluidics, a unique pressure and flow control technology with real-time sensing, surgeons can expect surgical stability and efficiency at each step of the procedure. 1 Significant advancements in instrumentation for vitreoretinal surgery include: UNITY 27 Gauge Portfolio: Instrumentation that through breakthrough design and the inclusion of the Dynamic Stiffener technology, surpasses the limitations of traditional 27-gauge tools, delivering the stiffness of a 25-gauge system or better, in a smaller gauge. 6 UNITY TetraSpot: A multi-spot illuminated laser probe that reduces laser application time by up to three times, enabling surgeons to deliver one, two, or four simultaneous laser spots for greater procedural versatility. 5,‡ UNITY Illumination: Reduces blue light exposure to the eye and includes customizable light profiles for excellent tissue visualization, while providing up to 10,000 hours of reliability. 1,8 'UNITY VCS has truly revolutionized the way I can perform during vitreoretinal surgeries,' said Maria H. Berrocal, MD, CEO, Drs. Berrocal & Associates. 'During my approximately 130 cases with this new technology, I saw efficiencies across surgery types. The unique fluidics control together with the faster cutting speeds have certainly been a game-changer, as well as the 27 gauge portfolio—taking the instrumentation to the next level with stiffness and performance similar to 25 gauge—all delivering stability and efficiency throughout the procedure.' The UNITY VCS/CS system is designed to allow cataract surgeons to operate with increased stability and efficiency at more physiologic conditions through its Intelligent Fluidics functionality. 1 This new technology maintains a consistent level of intraocular pressure (IOP) ∞ to help support patient comfort during surgery, while allowing for higher average vacuum during lens removal. 1 Other surgical performance enhancements include: UNITY Intelligent Sentry: Maintains anterior chamber stability while improving upon CENTURION ® Vision System with ACTIVE SENTRY ®, reducing post-occlusion surge volumes by 44%. 9,* UNITY Thermal Sentry: The first phacoemulsification handpiece that features a thermal sensor that works with a proprietary algorithm to estimate incision temperature in real-time and regulate ultrasound power. 1 'I perform thousands of cataract surgeries each year and UNITY VCS/CS has streamlined my surgical procedures while enabling us to consistently deliver exceptional patient outcomes,' said John Berdahl, MD. 'The UNITY 4D phaco technology in particular has been impressive—breaking up even large, dense cataracts efficiently, while maintaining more physiologic IOP throughout the surgery. Beyond the device performance, it expedites our surgical workflow and introduces significant usability improvements—which the entire team greatly appreciates.' UNITY VCS/CS is the first product to become available from Alcon's UNITY portfolio of next-generation surgical equipment solutions. UNITY VCS/CS users can benefit from Intelligent Services Solutions, including select remote service offerings and predictive service capabilities to minimize downtime. UNITY VCS has received CE Mark, and regulatory approvals in Australia, Japan and the U.S. Inventory will begin shipping to Australia, Europe, Japan and the U.S. from May onwards; and to other markets in third quarter of 2025 pending regulatory approvals. Surgeons attending the ASCRS annual meeting can demo the UNITY VCS/CS platform at Alcon Booth #1815. For more information, please visit or speak to your Alcon Sales Representative. About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at About UNITY ® VCS/CS Indications / Intended Use: The UNITY ® VCS (Vitreoretinal Cataract System) console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures. The UNITY ® CS (Cataract System) console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery. Refer to the Directions for Use for the accessories/consumables and User Manual for a complete listing of indications, warnings, cautions and notes. * Based on bench data; reduction in surge is correlated to less change in anterior chamber depth. † Based on N=10 handpieces, Artificial cataract lens IOP 55mmhg vacuum of 450 mmHg. ‡ Multiple-spot laser probe (4) is 3 times faster than single-spot laser probe. ∞ Mean fluctuation at flow vs. setpoint of 2.36 ± 2.13, 4.19 ± 1.97, 1.84 ± 2.82, and 2.13 ± 2.86 mmHg during phacoemulsification, irrigation/aspiration (IA), vitrectomy, and extrusion/fragmentation, respectively. References UNITY™ VCS and CS User Manual. Alcon Data on File, 2024. [REF-24644] Irannejad A, Tambat S, Abulon DJK. Retropulsion and Mass flow of 27-gauge Vitrectomy Probes: Comparison of Dual-blade/flat-tipped probes and single-blade/beveled probes. 2021. Poster presentation. Alcon Data on File, 2024. [REF-24379] Alcon Data on File, 2024. [REF-24615] Alcon Data on File, 2024. [REF-24576] Unity Phaco Handpiece Directions for Use. Alcon Data on File, 2024. [REF-24760] Alcon Data on File, 2024. [REF-25562] Connect with us on Facebook LinkedIn
Yahoo
25-03-2025
- Business
- Yahoo
Alcon signs merger agreement to acquire Lensar
Alcon has signed a definitive merger agreement to acquire Lensar to enhance its portfolio of cataract equipment and technology. Valued at nearly $356m, the acquisition will enhance Alcon's femtosecond laser-assisted cataract surgery (FLACS) capabilities by including Lensar's ALLY Robotic Cataract Laser Treatment System and Streamline software technology. The agreement stipulates that Alcon will purchase Lensar's all outstanding shares for $14.00 each in cash, with an additional contingent value right of up to $2.75 per share, based on the achievement of a specific procedural milestone. The total potential consideration could reach $430m, representing a significant premium over Lensar's recent volume-weighted average prices (VWAP). The transaction is expected to be finalised by mid-to-late 2025, subject to regulatory and Lensar stockholder approvals. Lazard and Norton Rose Fulbright are advising Alcon while Wells Fargo and Latham & Watkins are advising Lensar in this transaction. The FLACS technology enables surgeons to leverage a computer-guided laser for managing 'visually significant' astigmatism, conduct corneal incisions, capsulotomy as well as fragment the lens, eliminating the requirement of blade incisions. Alcon CEO David Endicott said: 'We are excited for the opportunity to bring Lensar's unique next-generation technologies and intellectual property into our innovative, market-leading equipment portfolio. 'By leveraging our global footprint, we have the opportunity to deliver the benefits of advanced femtosecond laser technology to many more surgeons around the world and continue to improve efficiency in cataract surgery.' Lensar's ALLY Robotic Cataract Laser System integrates AI into imaging and software, aiming to revolutionise cataract surgery with its robotic technologies. The system is tailored for use in both sterile operating rooms and in-office surgical suites, offering potential 'operational efficiencies' and decreased overhead. Lensar CEO Nick Curtis said: 'Our focus has been on providing surgeons with breakthrough laser technology in cataract surgery for today and tomorrow.' "Alcon signs merger agreement to acquire Lensar" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
24-03-2025
- Business
- Yahoo
Alcon Agrees to Acquire LENSAR, Inc.
Acquisition of ALLY Robotic Cataract Laser Systems strengthens Alcon's cataract equipment and technology portfolio Next generation technology will be expanded globally, improving the efficiency of cataract surgery GENEVA and ORLANDO, Fla., March 24, 2025 (GLOBE NEWSWIRE) -- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, and LENSAR, Inc. (NASDAQ: LNSR), a global medical technology company focused on advanced laser solutions for the treatment of cataracts, today announced the companies have entered into a definitive merger agreement through which Alcon intends to acquire LENSAR. The acquisition includes ALLY Robotic Cataract Laser Treatment System™, LENSAR's proprietary Streamline® software technology and LENSAR legacy laser system, building Alcon's femtosecond laser-assisted cataract surgery (FLACS) offering. Under the terms of the agreement, Alcon will purchase all outstanding shares of LENSAR for $14.00 per share in cash (an aggregate implied value of approximately $356 million*), with an additional non-tradeable contingent value right offering up to $2.75 per share in cash, conditioned on achievement of 614,000 cumulative procedures with LENSAR's products between January 1, 2026, and December 31, 2027. The total potential consideration of $16.75 per share represents a premium of 24% to LENSAR's 30-day VWAP and a premium of 47% to LENSAR's 90-day VWAP, assuming the milestone is met. The transaction represents a total consideration of up to approximately $430 million*. 'We are excited for the opportunity to bring LENSAR's unique next-generation technologies and intellectual property into our innovative, market-leading equipment portfolio,' said David Endicott, Chief Executive Officer of Alcon. 'By leveraging our global footprint, we have the opportunity to deliver the benefits of advanced femtosecond laser technology to many more surgeons around the world and continue to improve efficiency in cataract surgery.' Currently, there are more than 5 million cataract procedures in the U.S., and approximately 32 million globally.1 FLACS is designed to allow surgeons to utilize a computer-guided laser to address and manage the high prevalence of visually significant astigmatism, perform corneal incisions, capsulotomy, including a refractive capsulotomy, and lens fragmentation, removing the need for blade incisions. This can contribute to more precise, reproducible and reliable cataract surgery. 'Our focus has been on providing surgeons with breakthrough laser technology in cataract surgery for today and tomorrow,' said Nick Curtis, Chief Executive Officer of LENSAR. 'Thanks to the continued passion and commitment of LENSAR associates, customers and our investors, we are excited about the potential Alcon has to advance the industry in next-generation laser technology for refractive cataract surgery, furthering our and their mission to meet the needs of both surgeons and their cataract patients.' The transaction is anticipated to close in mid-to-late 2025, subject to customary closing conditions, including regulatory approval and approval by LENSAR's stockholders. Lazard is serving as financial advisor to Alcon, and Norton Rose Fulbright is serving as legal advisor to Alcon. Wells Fargo is serving as financial advisor to LENSAR and Latham & Watkins LLP is serving as legal advisor to LENSAR. Forward-looking StatementsThis press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the potential transaction between Alcon and LENSAR and the expected timing, impacts and benefits thereof, Alcon's and LENSAR's business strategies, performance, market adoption and usage. In some cases, you can identify forward-looking statements by terms such as 'aim,' 'anticipate,' 'approach,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'goal,' 'intend,' 'look,' 'may,' 'mission,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'pursue,' 'should,' 'target,' 'will,' 'would,' or the negative thereof and similar words and expressions. Forward-looking statements are based on Alcon's and LENSAR's management's current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions. The following factors could cause actual results and future events to differ materially from those set forth or contemplated in the forward-looking statements: (i) the proposed merger may not be completed in a timely manner or at all, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect LENSAR or the expected benefits of the proposed merger or that the approval of LENSAR's stockholders is not obtained; (ii) the failure to realize the anticipated benefits of the proposed merger; (iii) the possibility that competing offers or acquisition proposals for LENSAR will be made; (iv) risks that the milestone related to the contingent value rights is not achieved; (v) the possibility that any or all of the various conditions to the consummation of the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); (vi) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger, including in circumstances which would require LENSAR to pay a termination fee or other expenses; (vii) the effect of the announcement or pendency of the merger on LENSAR's ability to retain and hire key personnel, or its operating results and business generally, (viii) there may be liabilities related to the merger that are not known, probable or estimable at this time or unexpected costs, charges or expenses; (ix) the merger may result in the diversion of management's time and attention to issues relating to the merger; (x) there may be significant transaction costs in connection with the merger; (xi) legal proceedings may be instituted against LENSAR following the announcement of the merger, which may have an unfavorable outcome; and (xii) LENSAR's stock price may decline significantly if the merger is not consummated. In addition, a number of other important factors could cause LENSAR's actual future results and other future circumstances to differ materially from those expressed in any forward-looking statements, including but not limited to those important factors discussed under the heading 'Risk Factors' contained in Alcon's Annual Report on Form 20-F for the fiscal year ended December 31, 2024 and in LENSAR's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, each as filed with the Securities and Exchange Commission ('SEC'), as such factors may be updated from time to time in such company's other filings with the SEC, accessible on the SEC's website at and the Investor Relations section of LENSAR's website at and Alcon's website at All forward-looking statements are expressly qualified in their entirety by such factors. Except as required by law, neither Alcon nor LENSAR undertake any obligation to publicly update or review any forward-looking statement, whether because of new information, future developments or otherwise. These forward-looking statements should not be relied upon as representing Alcon's or LENSAR's views as of any date subsequent to the date of this press release. About AlconAlcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at About LENSARLENSAR is a commercial-stage medical device company focused on designing, developing, and marketing advanced systems for the treatment of cataracts and the management of astigmatism as an integral aspect of the procedure. LENSAR has developed its ALLY Robotic Cataract Laser System™ as a compact, highly ergonomic system utilizing an extremely fast dual-modality laser and integrating AI into proprietary imaging and software. ALLY is designed to transform premium cataract surgery by utilizing LENSAR's advanced robotic technologies with the ability to perform the entire procedure in a sterile operating room or in-office surgical suite, delivering operational efficiencies and reduced overhead. ALLY includes LENSAR's proprietary Streamline® software technology, designed to guide surgeons to achieve better outcomes. Learn more at Additional InformationThis press release may be deemed solicitation material in respect of the proposed acquisition of LENSAR. A special stockholder meeting will be announced soon to obtain stockholder approval in connection with the proposed merger. LENSAR expects to file with the SEC a proxy statement and other relevant documents in connection with the proposed merger. Investors of LENSAR are urged to read the definitive proxy statement and other relevant materials carefully and in their entirety when they become available because they will contain important information about the Company and the proposed merger. Investors may obtain a free copy of these materials (when they are available) and other documents filed by LENSAR with the SEC at the SEC's website at and at LENSAR's website at Participants in the SolicitationLENSAR and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed merger. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of LENSAR's stockholders in connection with the proposed merger will be set forth in LENSAR's definitive proxy statement for its special stockholder meeting. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed merger will be set forth in the definitive proxy statement when and if it is filed with the SEC in connection with the proposed merger. References 2025 Market Scope Data. Alcon Investor RelationsDaniel Cravens, Allen Trang+ 41 589 112 110 (Geneva)+ 1 817 615 2789 (Fort Worth) Alcon Media RelationsSteven Smith+ 41 589 112 111 (Geneva)+ 1 817 551 8057 (Fort Worth) LENSAR Investor RelationsThomas R. Staab, II, LENSAR Media RelationsLee Roth / Cameron RadinovicBurns McClellan for LENSARlroth@ / cradinovic@ _________________________________________ * Assuming use of the Treasury Stock Method
