FDA approves Alcon’s TRYPTYR for Dry Eye Disease treatment

Published 28/05/2025, 21:46
FDA approves Alcon’s TRYPTYR for Dry Eye Disease treatment

GENEVA - Alcon (SIX/NYSE: ALC), a prominent player in the Healthcare Equipment & Supplies sector with a market capitalization of $42.25 billion, announced the FDA approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for Dry Eye Disease (DED) treatment. According to InvestingPro data, the company maintains strong financials with $9.9 billion in revenue over the last twelve months. TRYPTYR is the first TRPM8 receptor agonist approved for this indication, offering a novel mechanism of action by stimulating corneal sensory nerves to increase natural tear production.

The approval is based on results from two Phase 3 clinical trials, which showed significant improvements in tear production as early as Day 1. In these trials, a notably higher percentage of patients treated with TRYPTYR experienced at least a 10mm increase in natural tear production by Day 14 compared to those given a vehicle.

DED affects approximately 38 million Americans, with less than 10% receiving prescription treatment. TRYPTYR represents a significant advancement for many patients who have found existing DED treatments inadequate due to slow onset or poor tolerability. With a healthy current ratio of 2.7 and strong liquidity position, InvestingPro analysis suggests Alcon is well-positioned to support this product launch. For deeper insights into Alcon’s market position and growth potential, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.

TRYPTYR will be available in single-dose vials, administered as one drop per eye twice daily. Alcon plans to launch the product in the U.S. in the third quarter of 2025 and aims to introduce it to other markets later.

The most common adverse reaction reported in clinical trials was instillation site pain. Patients are advised not to touch the vial tip to their eye or other surfaces to avoid injury and contamination, and not to administer the drops while wearing contact lenses.

This announcement marks Alcon’s first FDA-approved prescription pharmaceutical treatment since becoming an independent company. Trading near its 52-week low of $80.48, with the stock currently at $85.38, this approval could represent a significant catalyst for the company’s growth trajectory. The information reported is based on a press release statement and market data from InvestingPro.

In other recent news, Alcon Inc. has been the focus of several analyst reports and developments. Deutsche Bank downgraded Alcon’s stock from Buy to Hold, citing concerns over a slowdown in end markets and the potential impact of tariffs, while still expressing optimism about future product launches in 2025 and 2026. In contrast, BTIG and Stifel maintained their Buy ratings, with BTIG setting a price target of $99 and Stifel at $100. BTIG’s rating follows Alcon’s announcement of a clinical trial for its new Unity DX diagnostic system, which aims to improve clinical workflows. Stifel’s optimism is tied to the upcoming PDUFA date for Alcon’s AR-15512 eyedrop treatment for dry eye disease, despite some concerns about the competitive landscape and product launch challenges. Bernstein analysts also showed confidence, maintaining an Outperform rating while adjusting the price target to CHF99, following a positive outlook on Alcon’s innovation pipeline. They anticipate a robust product launch schedule in 2025, which aligns with Alcon’s strategic growth plans. Despite some financial pressures, analysts like Bernstein and Stifel expect Alcon’s new products to contribute to sales growth in the coming years.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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