- \n
- LumiThera\u2019s photobiomodulation (PBM) device is the first and only technology that has demonstrated meaningful visual improvement with two years of treatments* in early and intermediate dry AMD patients1,2<\/sup><\/b><\/li>\n
- Nearly 200 million people globally live with dry AMD, a progressive disease with no cure, and a leading cause of blindness in developed nations3,4<\/sup><\/b><\/li>\n
- Alcon aims to expand PBM office-based treatment in approved markets, underscoring its commitment to people living with retinal diseases<\/b><\/li>\n<\/ul>\n
GENEVA–(BUSINESS WIRE<\/a>)–
\nAlcon (SIX\/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced its intention to acquire LumiThera, Inc., a leader in light-based innovations for ophthalmology, and its PBM device for the treatment of early and intermediate dry AMD.1<\/sup> LumiThera\u2019s PBM is the only device that has demonstrated meaningful vision improvement compared to baseline for people living with early to intermediate dry AMD.2,*<\/sup> Dry AMD is a progressive disease typically treated in late stage, with limited treatment options.2<\/sup><\/p>\n\n\u201cFor more than 25 years, Alcon has been a leader in vitreoretinal surgery, and we are excited to expand our offerings into the clinic, to help millions of people living with dry AMD gain vision,\u201d said Sean Clark, Vice President and General Manager, Global Surgical Franchise, Alcon. \u201cDry AMD is an area of significant unmet need, and PBM is an efficacious, non-invasive light therapy that can provide visual improvement for patients with early and intermediate disease. With Alcon\u2019s global commercial and clinical expertise, we have the potential to make this therapy more broadly available to Eye Care Professionals and their patients, while continuing to strengthen its body of clinical evidence.\u201d<\/p>\n
\nIn dry AMD, vision loss results from the dysfunction and break down of retinal cells within the macula\u2014the part of the retina that allows for sharpness and fine detail in seeing what\u2019s directly in front of the viewer.4<\/sup> In the early stages, central vision becomes distorted and may ultimately progress to a complete loss, making everyday activities difficult, like reading, driving and even recognizing faces.5<\/sup><\/p>\n
\nThe retina is rich in mitochondria, and mitochondrial dysfunction is a known cause of vision loss in dry AMD.6<\/sup> PBM uses low-level light to stimulate mitochondrial energy production, promoting retinal cellular health. It uses three specific, science-backed wavelengths\u2014delivering non-phototoxic light therapy (not laser therapy).7,8<\/sup> The non-invasive treatments are administered while the patient is sitting comfortably in a clinic setting.<\/p>\n
\nData from the LIGHTSITE I, II, and III clinical trials consistently showed that PBM treatments provide visual acuity improvement with no treatment-related serious adverse events reported.2<\/sup> The pivotal LIGHTSITE III study was conducted at 10 sites across the U.S. and evaluated two years of PBM treatment versus a control light therapy. The results showed:<\/p>\n
- \n
- \nPatients with PBM-treated eyes on average experienced visual acuity improvement\u2014gaining one line of visual acuity (ETDRS) from Baseline at Months 13, 21 and maintained at Month 249<\/sup><\/li>\n
- \nAbout 88% of patients in the PBM group maintained or gained vision versus Baseline at Month 249<\/sup><\/li>\n
- \nNearly two-thirds of patients (64%) with PBM-treated eyes experienced visual acuity improvement\u2014gaining at least one line of visual acuity (ETDRS) from Baseline at Month 249<\/sup><\/li>\n
- \nMore than 97% of patients reported no pain or discomfort2,9<\/sup><\/li>\n
- \nMore than 80% of patients stayed on therapy for two years\u2014the recommended course of treatment2,9<\/sup><\/li>\n<\/ul>\n
\n\u201cAt LumiThera, we have been committed to developing novel light therapy technologies that address dry AMD,\u201d said Clark Tedford, Ph.D., President and CEO of LumiThera. \u201cOur PBM device provides a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss. We are thrilled that Alcon agrees in the potential that this device has to change the lives of millions living with dry AMD, and we are confident that Alcon has the capabilities to broadly commercialize it.\u201d<\/p>\n
\nPBM received FDA de novo market authorization in November 2024 and received CE Mark in November 2018. PBM is currently available in Europe, Latin America, Singapore, the U.K. and the U.S.<\/p>\n
\nThe transaction does not include the acquisition of AdaptDx and Nova\/Diopsys diagnostic devices, which will be separated and spun-off to LumiThera\u2019s shareholders prior to Alcon\u2019s acquisition and will continue to be marketed and sold by the LumiThera spin-off. Subject to customary closing conditions and a LumiThera shareholder vote, Alcon and LumiThera anticipate the acquisition to be completed in the third quarter of 2025.<\/p>\n
Forward-looking Statements<\/span><\/b><\/p>\n
\nThis press release contains, and our officers and representatives may from time to time make, certain \u201cforward-looking statements\u201d within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as \u201canticipate,\u201d \u201cintend,\u201d \u201ccommitment,\u201d \u201clook forward,\u201d \u201cmaintain,\u201d \u201cplan,\u201d \u201cgoal,\u201d \u201cseek,\u201d \u201ctarget,\u201d \u201cassume,\u201d \u201cbelieve,\u201d \u201cproject,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cstrategy,\u201d \u201cfuture,\u201d \u201clikely,\u201d \u201cmay,\u201d \u201cshould,\u201d \u201cwill\u201d and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential transaction and the expected timing, impacts and benefits thereof.<\/p>\n
\nForward-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 such as: (i) the proposed merger may not be completed in a timely manner or at all; (ii) the failure to realize the anticipated benefits of the proposed merger; and (iii) there may be liabilities related to the merger that are not known, probable or estimable at this time or unexpected costs, charges or expenses.<\/p>\n
\nAdditional 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 of its filing, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise.<\/p>\n
About Alcon<\/span><\/b><\/p>\n
\nAlcon 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\u2019s 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 www.alcon.com<\/a>.<\/p>\n
About LumiThera<\/span><\/b><\/p>\n
\nLumiThera, Inc. is an ophthalmic medical device company that is Harnessing the Power of Light\u2122 to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, specifically dry AMD. LumiThera is the leader in ophthalmic PBM innovation; for more information visit www.lumithera.com<\/a>.<\/p>\n
About PBM<\/span><\/b><\/p>\n
\nThe photobiomodulation (PBM) device (a.k.a. Valeda)multiwavelength treatments are for patients suffering from dry AMD. The Food & Drug Administration (FDA) has authorized marketing of the PBM device treatment for dry AMD patients to improve vision.<\/p>\n
\n*It is possible that treatment benefit may not persist significantly after treatment is stopped.<\/p>\n
Important Product Information<\/span><\/b><\/p>\n
Indications for Use<\/b><\/p>\n
\nThe Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20\/32 through 20\/70 and who have dry age-related macular degeneration (AMD) characterized by:<\/p>\n
- \n
- \nThe presence of at least 3 medium drusen (> 63 \u03bcm and = 125 \u03bcm in diameter), or large drusen (> 125 \u03bcm in diameter), or non-central geographic atrophy, AND<\/p>\n<\/li>\n
- \nThe absence of neovascular maculopathy or central-involving geographic atrophy<\/p>\n<\/li>\n<\/ul>\n
\nAfter about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment.<\/p>\n
Contraindications for Use<\/b><\/p>\n
\nAs a precaution, patients have not been tested and should not be treated with Valeda if they have any known photosensitivity to yellow light, red light, or near-infrared radiation (NIR), or if they have a history of light-activated central nervous system disorders (e.g., epilepsy, migraine). In addition, patients should not receive treatment within 30 days of using photosensitizing agents (e.g., topicals, injectables) that are affected by 590, 660, and\/or 850 nm light before consulting with their physician.<\/p>\n
Precautions<\/b><\/p>\n
\nIt is possible that treatment benefit may not persist significantly after treatment is stopped. The clinical study provided no significant data concerning the safety and effectiveness of the device should treatments be applied more frequently than described in this manual, or if more than 54 total treatments are delivered per eye.<\/p>\n
References<\/span><\/b><\/p>\n
- \n
- \nU.S. Food and Drug Administration. De Novo classification request for Valeda Light Delivery System (DEN230083). Accessed June 2025 at https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf23\/DEN230083.pdf<\/a>.<\/p>\n<\/li>\n
- \nLumiThera, Inc. A double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) (LIGHTSITE III). Clinical Study Report CSP005.<\/p>\n<\/li>\n
- \nWong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014;2(2):e106\u2013e116. DOI: 10.1016\/S2214-109X(13)70145-170145-1.<\/p>\n<\/li>\n
- \nCenters for Disease Control and Prevention. About Common Eye Disorders and Diseases. Accessed in June 2025 at www.cdc.gov\/vision-health\/about-eye-disorders\/index.html<\/a>.<\/p>\n<\/li>\n
- \nMitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. The Lancet. 2018;392(10153):1147\u20131159. DOI: 10.1016\/S0140-6736(18)31550-2.<\/p>\n<\/li>\n
- \nEells JT. Mitochondrial dysfunction in the aging retina. Biology (Basel). 2019;8(2):31. DOI: 10.3390\/biology8020031.<\/p>\n<\/li>\n
- \nWong-Riley MTT, Liang HL, Eells JT, Chance B. Photobiomodulation directly benefits primary neurons functionally inactivated by toxins: Role of cytochrome c oxidase. J Biol Chem. 2005;280(6):4761\u20134771. DOI: 10.1074\/jbc.M409650200.<\/p>\n<\/li>\n
- \nBall KA, Castello PR, Poyton RO. Low intensity light stimulates nitrite-dependent nitric oxide synthesis but not oxygen consumption by cytochrome c oxidase: Implications for phototherapy. Biochim Biophys Acta. 2011;1807(7):964\u2013970. DOI: 10.1016\/j.bbabio.2011.04.003.<\/p>\n<\/li>\n
- \nValeda\u00ae<\/sup> Light Delivery System User Manual (LBL-0001-01 REV C).<\/p>\n<\/li>\n<\/ol>\n
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Alcon Investor Relations
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Daniel Cravens, Allen Trang
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+ 41 589 112 110 (Geneva)
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+ 1 817 615 2789 (Fort Worth)
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investor.relations@alcon.com<\/a><\/p>\nAlcon Media Relations
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Steven Smith
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globalmedia.relations@alcon.com<\/a><\/p>\nKEYWORDS:<\/b> Europe Switzerland United States North America Texas<\/p>\n
INDUSTRY KEYWORDS:<\/b> Health Medical Devices Other Health General Health Clinical Trials Optical Biotechnology<\/p>\n
- \nU.S. Food and Drug Administration. De Novo classification request for Valeda Light Delivery System (DEN230083). Accessed June 2025 at https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf23\/DEN230083.pdf<\/a>.<\/p>\n<\/li>\n
- \nAbout 88% of patients in the PBM group maintained or gained vision versus Baseline at Month 249<\/sup><\/li>\n
- Nearly 200 million people globally live with dry AMD, a progressive disease with no cure, and a leading cause of blindness in developed nations3,4<\/sup><\/b><\/li>\n
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