Alcon Secures First FDA Approval for Prescription Drug Since Novartis Split

Alcon, the eye care specialist formerly part of Novartis, has achieved a significant milestone with its first FDA approval for a prescription drug since becoming an independent company in 2019. The approval for Tryptyr (acoltremon ophthalmic solution) marks a new chapter in Alcon's growth strategy and expands its portfolio in the dry eye disease (DED) market.

Tryptyr: A Novel Approach to Dry Eye Disease

Tryptyr, a first-in-class TRPM8 receptor agonist, is designed to activate tear production in patients suffering from DED. Administered as a single drop twice daily, the treatment directly addresses tear deficiency, a known cause of the condition. Dr. Marjan Farid, professor of ophthalmology at the University of California, Irvine, highlighted the unique mechanism of action, stating, "Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency."

The FDA approval was supported by two phase 3 trials involving over 930 DED patients. In one study, 43% of patients using Tryptyr demonstrated a 10-millimeter increase in natural tear production on the Schirmer test at Day 14, compared to only 8% in the vehicle group. A second study showed even more promising results, with 53% of Tryptyr patients achieving the same improvement versus 14% in the control group.

Market Potential and Launch Plans

With approximately 38 million Americans affected by DED and less than 10% of diagnosed patients currently receiving prescription treatment, Alcon sees significant market potential for Tryptyr. David Endicott, CEO of Alcon, expressed enthusiasm about the approval, calling it a "tremendous milestone" for the 80-year-old company.

Alcon plans to launch Tryptyr in the third quarter of this year, potentially capturing a substantial portion of the underserved DED market. The company's recent financial performance, with reported 2024 revenue of $9.8 billion (up 5% from the previous year), provides a strong foundation for the product launch.

Alcon's Strategic Growth Since Novartis Split

Since its separation from Novartis in 2019, Alcon has pursued an aggressive growth strategy. Notable acquisitions include:

1. A $770 million deal to acquire Aerie Pharmaceuticals in 2022, adding glaucoma and ocular hypertension medications Rhopressa and Rocklatan to its portfolio.
2. A $355 million agreement for U.S. rights to Novartis' Simbrinza, which also treats glaucoma and ocular hypertension.
3. A $60 million transaction with Kala Pharmaceuticals to acquire the DED treatment Eysuvis.

Furthermore, Alcon recently secured a majority stake in clinical-stage company Aurion Biotech, further expanding its reach in the ophthalmology space.

The approval of Tryptyr, combined with these strategic moves, positions Alcon as a growing force in the eye care market, particularly in the treatment of dry eye disease and related conditions.