Latest news with #DED
WebMD
4 days ago
- Business
- WebMD
FDA Approves New Treatment for Dry Eye Disease
May 30, 2025 -- The FDA has approved a new treatment for dry eye disease (DED) after studies showed it can help stimulate natural tear production as early as the first day of use. The new drug, known as acoltremon but sold as Tryptyr, is the first of its kind that offers hope to about 38 million people in the U.S. living with DED, fewer than 10% of whom currently use prescription treatments. DED is a condition where the eyes don't make enough tears or when tears dry up too quickly. It can cause burning, itching, light sensitivity, blurry vision, and a gritty or sandy feeling. Once thought to mostly affect older adults, it can affect all age groups, often due to long screen times. Many treatments are slow to work or hard to use, highlighting the need for better options that treat the root cause, not just the symptoms. Alcon, the maker of Tryptyr, says the FDA approved the drug based on two late-stage trials with about 930 people who have dry eye disease. Participants got either Tryptyr or a placebo. By day 14, up to four times more people using Tryptyr boosted their tear production. In the two trials, 42.6% and 53.2% of Tryptyr users improved, compared to just 8.2% and 14.4% of placebo users. The drug also started relieving symptoms as early as day one, with effects lasting through day 90. Tryptyr works by targeting TRPM8 proteins that activate nerves in the eye to boost tear production. It comes in single-use vials, with one drop needed in each eye twice a day. Alcon plans to launch it in the U.S. in the third quarter of 2025. Marjan Farid, MD, professor of ophthalmology at the University of California, Irvine, said the new treatment option might overcome the current challenges for patients. 'Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease,' she said in a statement.
Hi Dubai
6 days ago
- Business
- Hi Dubai
How to Legally Expand Your Business in Dubai Without Changing Your License
Dubai's economy is on an impressive upward track, growing by 3.1% in the first nine months of 2024 and reaching AED 339.4 billion, according to Digital Dubai. What's driving this momentum? Key sectors like wholesale and retail trade have grown by 2.9%, transportation and storage by 5.3%, and financial and insurance activities by 4.5%. As these industries expand, so does Dubai's potential as a global business hub. But what's the bigger vision? The emirate's ambitions are clearly outlined in the Dubai Economic Agenda D33, which aims to double the economy by 2033. This is supported by major reforms, most notably the decision to allow 100% foreign ownership of onshore companies since June 1, 2021. These changes are not just policy shifts, they're open invitations for global businesses to grow in Dubai. But with such an opportunity comes the need for caution. Are you operating with the right licenses? Failing to comply with licensing regulations can be costly, with penalties reaching up to AED 50,000—or worse, complete business closure. So how can businesses expand in Dubai without changing their core license or running into compliance issues? In this article, we explore legal ways to grow your business in Dubai without altering your original license structure, helping you scale safely and strategically . Understanding Your Existing License with DET The Dubai Department of Economy and Tourism (DET), formerly DED, is the primary authority for business registration and licensing in Mainland Dubai. DET oversees corporate strategy, business registration, and compliance. Key License Types: Commercial License: For buying, selling, importing/exporting. For buying, selling, importing/exporting. Professional License: For services like accounting, legal, and marketing. For services like accounting, legal, and marketing. Industrial License: For manufacturing, processing, and assembling. Benefits of a DET License: Enhanced Credibility: Official government endorsement builds trust. Official government endorsement builds trust. Market Access: Direct access to Dubai's market, including government tenders. Direct access to Dubai's market, including government tenders. Flexible Visa Policies: Typically one visa per 100 square feet of office space. Typically one visa per of office space. 100% Foreign Ownership: Permitted in most mainland industries. Permitted in most mainland industries. No Minimum Capital: Generally, no minimum capital is required for DED-licensed mainland companies. Generally, no minimum capital is required for DED-licensed mainland companies. Tax Advantages: While historically offering significant benefits, corporate tax was introduced in June 2023, applying a 9% rate on net profits exceeding AED 375,000. Diversifying Activities Under Your Existing Mainland License The UAE government allows businesses to add new activities to an existing trade license, provided all legal requirements are met. Engaging in unlisted activities can result in fines from AED 5,000 to AED 50,000. Process Highlights: Initial Approval: Obtain approval from DET for proposed new activities. Application Submission: Submit the BR1 form for license amendment. NOCs & Legalities: Secure No Objection Certificates (NOCs) from relevant authorities if needed, and complete legal formalities (e.g., LLC agreement addendum). Final Steps: Submit all documents, pay fees (around AED 3,000 for mainland, AED 2,000 for free zones), and receive your updated license. Benefits: Unlocking new revenue streams, staying competitive, enhancing credibility, and optimizing existing resources. Free Zone to Mainland Expansion Under New Regulations Executive Council Resolution No. 11 of 2025, issued on March 3, 2025, allows Dubai free zone businesses to operate directly in the mainland. This is a core part of Dubai's D33 economic agenda. Pathways for Free Zone Entities: Onshore Dubai Branch (physical presence required): Valid for one year, renewable. Onshore Dubai Branch (HQ in free zone, no physical presence): Valid for one year, renewable, with an annual fee of AED 10,000. Temporary Permits for Specific Activities: Valid for up to six months, with a fee of AED 5,000 annually. The DET, in coordination with licensing authorities, is expected to issue a comprehensive list of permissible activities by September 20, 2025.A significant benefit is the ability to use the existing free zone-registered workforce for mainland operations, leading to cost savings. Leveraging Digital Expansion with E-commerce and Virtual Licenses Dubai's e-commerce market is projected to reach USD 8 billion by 2025. An e-commerce license is essential for legal online operations. Adding E-commerce Activities: Businesses with existing mainland commercial licenses can add e-commerce activities following the standard amendment process. Types of E-commerce Licenses: E-Trader License: For UAE/GCC nationals, home-based businesses, social media sales (no physical shop/visa). For UAE/GCC nationals, home-based businesses, social media sales (no physical shop/visa). Portal License: For online platforms connecting buyers and sellers. For online platforms connecting buyers and sellers. Virtual Company License: For non-resident entrepreneurs, allowing remote operation without a physical office is considered cost-effective. Cost: A Dubai e-commerce license in 2025 typically ranges from AED 5,750 to AED 15,000, depending on jurisdiction, office needs, and visa allocations. Establishing a Branch or Representative Office (An Extension, Not a Change) Foreign companies can establish a direct presence in Dubai through branch or representative offices without altering their parent company's license. Branch Office: Functions as an extension of a foreign parent company, authorized to conduct commercial activities. Requires a physical office and a Local Service Agent (LSA). The Ministry of Economy (MOE) mandates a capital deposit of AED 50,000 . Functions as an extension of a foreign parent company, authorized to conduct commercial activities. Requires a physical office and a Local Service Agent (LSA). The Ministry of Economy (MOE) mandates a capital deposit of . Representative Office: Established solely for promotional activities, not direct sales. Requires a UAE national as a local agent. No minimum share capital is required, but a refundable MOE deposit of AED 50,000 is typically required. Franchising: A Double-Edged Sword for Business Expansion The MENA franchising industry is growing, with Dubai's market projected to reach USD 44 billion by 2026, expanding by 12% annually. The current market size exceeds AED 30 billion annually, with growth rates averaging 12-15% year over year. Franchise businesses often achieve 25-30% higher success rates and 40% faster profitability compared to independent startups. Why Franchising Can Be a Risky Bet: Unsuitability: A business may not be viable for replication if its core elements aren't distinctive or strong enough to attract franchisees. A business may not be viable for replication if its core elements aren't distinctive or strong enough to attract franchisees. Lack of IP Protection: Unregistered trademarks can hinder franchising. Unregistered trademarks can hinder franchising. Complex Operations: If the business system is too complicated or difficult to reproduce consistently, it's not suitable. If the business system is too complicated or difficult to reproduce consistently, it's not suitable. Unprofitable Model: Franchises are often less profitable than the original business due to startup costs like franchise fees and supplies. Franchises are often less profitable than the original business due to startup costs like franchise fees and supplies. Weak Brand Recognition: A lack of strong brand recognition makes it harder to attract franchisees and customers. Common Pitfalls for Franchisees: Inadequate Market Research: Not understanding local demand, competition, or ideal location. Not understanding local demand, competition, or ideal location. Underestimating Costs: Beyond initial fees, ongoing expenses like royalty fees (typically 5-8% of gross revenue) and marketing contributions (another 2-3% ) can be substantial. Beyond initial fees, ongoing expenses like royalty fees (typically of gross revenue) and marketing contributions (another ) can be substantial. Wrong Franchise Model: Selecting a concept that lacks local demand or fails to adapt to cultural preferences. Selecting a concept that lacks local demand or fails to adapt to cultural preferences. Neglecting Training & Support: Insufficient training and ongoing support from the franchisor can lead to operational inefficiencies. Insufficient training and ongoing support from the franchisor can lead to operational inefficiencies. Franchisor Instability: Financial difficulties of the franchisor can severely impact franchisees. Financial difficulties of the franchisor can severely impact franchisees. Market Saturation: Over-saturation or unclear territorial rights can lead to internal competition. The legal framework for franchising in the UAE is governed by the Commercial Agencies Law (Federal Law No. 18 of 1981), the Commercial Companies Law, and contract law. Commercial agents (franchisees) must register with the Ministry of Economy. Franchisors are legally obligated to provide a comprehensive disclosure document to potential franchisees. Dubai's dynamic regulatory environment supports business expansion without requiring a complete license change. Strategies include diversifying activities under existing mainland licenses, leveraging the new free zone to a mainland expansion framework (Executive Council Resolution No. 11 of 2025), embracing digital growth via e-commerce and virtual licenses, and establishing branch or representative offices. While franchising offers growth potential, it demands careful viability assessment and adherence to legal obligations. Each pathway offers distinct advantages, requiring meticulous planning and compliance for sustained success in this global business hub. (Main Sources: Also read: Can Foreigners Really Own 100% of a Business in the UAE? Here's the Truth Explore the evolution of foreign ownership restrictions in the UAE, from their historical roots to the groundbreaking 2020 reforms and the sectors that still require local ownership. Small Business Licence Cost In Dubai We'll explore the cost of a small business licence in Dubai, and guide you through the steps required to launch your business successfully. 6 Simple Steps To Set Up A Business In A UAE Free Zone Establishing a business in a UAE Free Zone is straightforward and can be completed in six simple steps, as outlined by the Ministry of Economy. The Benefits of Dubai's Free Zones for Entrepreneurs This article explores the many advantages that Dubai's free zones offer, making them an attractive proposition for entrepreneurs worldwide.
Yahoo
6 days ago
- Business
- Yahoo
Alcon Inc. (ALC)'s TRYPTYR Wins FDA Nod for Dry Eye Disease
Alcon Inc. (NYSE:ALC) has announced that the U.S. Food and Drug Administration (FDA) has approved TRYPTYR (acoltremon ophthalmic solution) 0.003% for the treatment of signs and symptoms of Dry Eye Disease (DED), marking a major milestone for Alcon Inc. (NYSE:ALC) and patients alike. TRYPTYR is the first-in-class TRPM8 receptor agonist eye drop, designed to rapidly stimulate natural tear production by targeting corneal sensory nerves, a novel approach for DED management. A healthcare professional wearing a health communications device discussing patient data with a colleague. In pivotal Phase 3 trials (COMET-2 and COMET-3), TRYPTYR demonstrated a significant increase in natural tear production as early as Day 1, with up to four times more patients achieving at least a 10mm increase in tear production at Day 14 compared to placebo (42.6% vs 8.2% in COMET-2; 53.2% vs 14.4% in COMET-3). These results were consistent through Day 90, highlighting its rapid and sustained efficacy. With nearly 38 million Americans affected by DED but less than 10% receiving prescription treatment, TRYPTYR addresses a critical unmet need, especially given the dissatisfaction and slow onset associated with existing therapies. Alcon Inc. (NYSE:ALC) expects to launch TRYPTYR in the U.S. in the third quarter of 2025. While we acknowledge the potential of ALC to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ALC and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. 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
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;
