FDA Approves Alcon's Dry Eye Treatment Tryptyr

The FDA has given its approval to Alcon's Tryptyr (acoltremon) eye drops for the treatment of dry eye disease (DED). This marks a significant milestone for Alcon as it is the first prescription product approved for the company since it became an independent entity post its separation from Novartis. Alcon CEO David Endicott expressed optimism about the new treatment, emphasizing its potential as a rapid-acting solution for many dry eye patients.

Tryptyr, originally known as AR-15512, became part of Alcon's offerings in 2022 following the acquisition of Aerie Pharmaceuticals for nearly $770 million. This approval positions Tryptyr as a frontrunner in DED treatment, particularly as a first-in-class TRPM8 receptor agonist. This formulation works by stimulating corneal sensory nerves, leading to an increase in natural tear production. The approval gives Tryptyr an edge over Aldeyra’s investigational treatment reproxalap, which faced rejection from the FDA twice, once initially in 2023 and again recently.

The FDA's approval of Tryptyr is backed by compelling clinical evidence from the Phase III COMET-2 and COMET-3 trials. These trials demonstrated a significant increase in natural tear production among participants. Specifically, those using Tryptyr showed at least a 10 mm increase in tear production by day 14 compared to the control group — 42.6% versus 8.2% in the COMET-2 trial and 53.2% versus 14.4% in COMET-3. Remarkably, Tryptyr showed significant tear production results as early as day 1, with these effects persisting through day 90.

Alcon has announced that Tryptyr will be available as a 0.003% ophthalmic solution in single-dose vials, intended for use twice daily. The company is preparing for a U.S. launch in the third quarter, with plans to expand internationally soon after. While Stifel analysts have shown optimism regarding Tryptyr's approval, they have also noted potential challenges that could impact its launch. These challenges include potential side effects such as transient burning or stinging sensations, as well as mixed symptomatic results that might affect its labeling. Additionally, increasing competition in the DED sector could pose challenges.

Apart from Tryptyr, Alcon has other FDA-approved treatments for DED, including Eysuvis (loteprednol etabonate), acquired from Kala Pharmaceuticals in 2022, and Bausch + Lomb's Xiidra (lifitegrast), which came from Novartis a year later. Alcon also offers a range of over-the-counter products for dry eye relief, including Systane Dry Eye Drops and GenTeal Tears.

In summary, the approval of Tryptyr represents a significant leap forward for Alcon in the realm of prescription eye care. With its innovative mechanism of action and supportive clinical data, Tryptyr is poised to become a valuable treatment option for individuals suffering from dry eye disease. As Alcon prepares for its U.S. debut, the company is also laying the groundwork for global expansion, despite potential challenges in a competitive market landscape.