Latest news with #LIGHTSITEIII
Business Wire
07-07-2025
- Business
- Business Wire
Alcon to Acquire LumiThera and Its Photobiomodulation Device for the Treatment of Early and Intermediate Dry Age-Related Macular Degeneration (AMD)
GENEVA--(BUSINESS WIRE)--Alcon (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 LumiThera's PBM is the only device that has demonstrated meaningful vision improvement compared to baseline for people living with early to intermediate dry AMD. 2,* Dry AMD is a progressive disease typically treated in late stage, with limited treatment options. 2 'For 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,' said Sean Clark, Vice President and General Manager, Global Surgical Franchise, Alcon. 'Dry 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's 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.' In dry AMD, vision loss results from the dysfunction and break down of retinal cells within the macula—the part of the retina that allows for sharpness and fine detail in seeing what's directly in front of the viewer. 4 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 The retina is rich in mitochondria, and mitochondrial dysfunction is a known cause of vision loss in dry AMD. 6 PBM uses low-level light to stimulate mitochondrial energy production, promoting retinal cellular health. It uses three specific, science-backed wavelengths—delivering non-phototoxic light therapy (not laser therapy). 7,8 The non-invasive treatments are administered while the patient is sitting comfortably in a clinic setting. Data 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 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: Patients with PBM-treated eyes on average experienced visual acuity improvement—gaining one line of visual acuity (ETDRS) from Baseline at Months 13, 21 and maintained at Month 24 9 About 88% of patients in the PBM group maintained or gained vision versus Baseline at Month 24 9 Nearly two-thirds of patients (64%) with PBM-treated eyes experienced visual acuity improvement—gaining at least one line of visual acuity (ETDRS) from Baseline at Month 24 9 More than 97% of patients reported no pain or discomfort 2,9 More than 80% of patients stayed on therapy for two years—the recommended course of treatment 2,9 'At LumiThera, we have been committed to developing novel light therapy technologies that address dry AMD,' said Clark Tedford, Ph.D., President and CEO of LumiThera. 'Our 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.' PBM 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. The transaction does not include the acquisition of AdaptDx and Nova/Diopsys diagnostic devices, which will be separated and spun-off to LumiThera's shareholders prior to Alcon's 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. Forward-looking Statements This press release contains, and our officers and representatives may from time to time make, certain 'forward-looking statements' 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 '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. Examples of forward-looking statements include, among others, statements we make regarding the potential transaction and the expected timing, impacts and benefits thereof. 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 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. Additional 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. 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 LumiThera LumiThera, Inc. is an ophthalmic medical device company that is Harnessing the Power of Light™ 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 About PBM The 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. *It is possible that treatment benefit may not persist significantly after treatment is stopped. Important Product Information Indications for Use The 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: The presence of at least 3 medium drusen (> 63 μm and = 125 μm in diameter), or large drusen (> 125 μm in diameter), or non-central geographic atrophy, AND The absence of neovascular maculopathy or central-involving geographic atrophy After 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. Contraindications for Use As 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. Precautions It 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. References U.S. Food and Drug Administration. De Novo classification request for Valeda Light Delivery System (DEN230083). Accessed June 2025 at LumiThera, 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. Wong 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–e116. DOI: 10.1016/S2214-109X(13)70145-170145-1. Centers for Disease Control and Prevention. About Common Eye Disorders and Diseases. Accessed in June 2025 at Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. The Lancet. 2018;392(10153):1147–1159. DOI: 10.1016/S0140-6736(18)31550-2. Eells JT. Mitochondrial dysfunction in the aging retina. Biology (Basel). 2019;8(2):31. DOI: 10.3390/biology8020031. Wong-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):4761–4771. DOI: 10.1074/jbc.M409650200. Ball 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):964–970. DOI: 10.1016/ Valeda ® Light Delivery System User Manual (LBL-0001-01 REV C).
Business Wire
08-05-2025
- Business
- Business Wire
LumiThera's LIGHTSITE IIIB Extension Trial Topline Results Show Extended Vision Improvement in Dry AMD Subjects
SEATTLE--(BUSINESS WIRE)--LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the topline results from the LIGHTSITE IIIB Extension Trial, a prospective, open-label trial in dry (non-neovascular) age-related macular degeneration (AMD) subjects. The extension trial followed subjects that completed the pivotal LIGHTSITE III trial and resumed treatment for 13 months with the Valeda ® Light Delivery System. Dry AMD is a leading cause of central vision loss in people over 55 in developed countries. Valeda is the first FDA-authorized treatment (November, 2024) to improve vision in dry AMD patients. In the pivotal U.S. LIGHTSITE III trial, Valeda met the primary endpoint and was shown to be safe and effective. Valeda demonstrated an improvement in best corrected visual acuity (BCVA) for 24 months of >5 letters or equivalent to one line improvement on the eye chart. 'The LIGHTSITE IIIB Extension Trial results extend two-year pivotal trial vision benefits out to 4.5 years and showed an excellent safety profile,' stated David Boyer, MD, FASRS, Retina Vitreous Associates Medical Group, Beverly Hills, CA. 'This is very exciting data for early to intermediate dry AMD patients. The 4.5-year follow-up included a 20-month no-treatment period between the two trials, wherein the patients still maintained some vision benefit from the earlier pivotal trial and recovered vision upon retreatment in the extension trial.' The trial results were presented on May 7 th at the 2025 Meeting of the Association for Research in Vision and Ophthalmology 2025 (ARVO) by co-investigators Diane Do, MD, FASRS and Quan Dong Nguyen, MD, MSc, FARVO, FASRS, Byers Eye Institute, Stanford University. The ARVO Annual Meeting is the premiere gathering for eye and vision scientists from across the globe, at all career stages, students, and those in affiliated fields to share the latest research findings and collaborate on innovative solutions and was held May 4 - 8 in Salt Lake City, Utah. 'The primary endpoint of the trial was BCVA gain. After another 13 months of treatment, although the size of the study population of LIGHTSITE IIIB is relatively small, >60% of the subjects that received Valeda treatment in both studies were still showing a benefit in vision of over one line,' indicated Quan Dong Nguyen, MD. MSc, FARVO, FASRS, Professor of Ophthalmology, Medicine, and Pediatrics at the Stanford University School of Medicine. 'What is exciting is this is the first and only FDA-authorized treatment that can improve vision with extended benefits out to 4.5 years, suggesting that earlier and extended treatment provides the best outcomes.' 'There is now a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss,' stated Clark Tedford, Ph.D., President and CEO, LumiThera, Inc. 'The extended trial results demonstrate that Valeda is potentially modifying the trajectory of vision loss in dry AMD patients and can offer sustainable benefits over several years with continued treatment.' About AMD AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million). About LumiThera LumiThera, Inc. is an ophthalmic medical device company that is Harnessing the Power of Light ™ to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, specifically dry AMD. LumiThera is the leader in ophthalmic PBM innovation with its flagship product, the Valeda ® Light Delivery System. Multiwavelength Valeda treatments are for patients suffering from dry AMD. The Food & Drug Administration (FDA) has authorized marketing of Valeda treatment for dry AMD patients to improve vision. Valeda is CE Marked in the EU, UKCA Marked in the UK, and is available in select countries in Latin America. AdaptDx Pro® is a portable dark adaptometer that utilizes artificial intelligence to deliver a uniform patient experience. Impaired dark adaptation speed indicates rod-mediated dysfunction, one of the first functional signs of retinal disease. AdaptDx Pro is available in the U.S. and Canada. NOVA Vision Testing System is a comprehensive electrophysiology platform that provides objective assessment of the entire pathway for visual and neuro-visual disorders. Visual evoked potential is available in the U.S. and select countries outside of the U.S. Electroretinography is only available outside of the U.S. For more information on Valeda, visit AdaptDx Pro and NOVA are available through LumiThera Diagnostics, Inc. and Diopsys, Inc., respectively.
