Latest news with #Tryptyr
WebMD
a day 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.
Business Insider
3 days ago
- Business
- Business Insider
Alcon's Tryptyr approved by FDA for signs and symptoms of Dry Eye Disease
Alcon (ALC) announced the 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. Tryptyr is a first-in-class TRPM8 receptor agonist that stimulates corneal sensory nerves to rapidly increase natural tear production. This approval is supported by two Phase 3 clinical trials evaluating more than 930 patients in which up to four times more Tryptyr patients experienced at least a 10mm increase in natural tear production at Day 14. Tryptyr demonstrated statistically significant natural tear production as early as Day 1. Alcon expects to launch Tryptyr in the U.S. in Q3 2025 and anticipates bringing Tryptyr to other markets in the future. Confident Investing Starts Here:
Reuters
3 days ago
- Business
- Reuters
US FDA approves Alcon's new dry-eye drug
May 28 (Reuters) - Eye-care drugmaker Alcon (ALCC.S), opens new tab said on Wednesday that the U.S. Food and Drug Administration has approved its treatment for dry eye disease (DED). Spun off from Novartis (NOVN.S), opens new tab in 2019, Alcon is betting on new product launches to accelerate sales growth in the second half of 2025 and beyond. The approval was based on late-stage studies in which the liquid medication, Tryptyr, demonstrated natural tear production as early as day one. The company said Tryptyr stimulates corneal sensory nerves to quickly increase natural tear production. DED is a condition in which the eyes either do not produce enough tears or produce poor-quality tears, leading to discomfort and potentially affecting vision. The company said about 38 million individuals in the United States suffer from DED, yet fewer than 10% of diagnosed patients are being treated with a prescription product. Alcon, which produces contact lenses, dry eye drops, gels and other related products, expects to launch Tryptyr in the United States during the third quarter of 2025, with plans to introduce the treatment in other markets later. Other FDA-approved treatments for DED include Alcon's Eysuvis and Bausch + Lomb's ( opens new tab Xiidra. Last month, however, the FDA declined to approve Aldeyra Therapeutics' (ALDX.O), opens new tab treatment for DED.
