BLOG: We don’t know what dry eye is, but we sure have a lot of ways to treat it
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Ever heard of a helical collagen intercalator? How about a TRPM8 agonist? Maybe RASP as a target of treatment?
All these unfamiliar names are descriptors of the mechanism of action for investigational treatments for dry eye disease. If you’re confused with the dry eye treatments on the market already, just wait for the party really to get crowded.
It seems the only question more pressing than how do we pay for these drugs is how we choose one treatment over another for a specific patient.
It sure would help if we better understood dry eye. Groups of smart people have defined and categorized it multiple ways, and published algorithms offer some help, but patients have so much individual variability, it’s difficult to imagine studies that could adequately pair all the different types of patients with all the current — let alone emerging — therapies.
Here’s an incomplete list of drugs in the pipeline for dry eye in the U.S.:
- Stuart Therapeutics, ST-100, a PolyCol molecule designed to intercalate in key damaged area of helical collagen. Phase 2/3.
- Alcon, AR-15512, a TRPM8 receptor agonist with positive topline phase 3 results.
- Glaukos, GLK-301, a pilocarpine cream applied externally twice daily with positive phase 2a results.
- Harbour BioMed, HBM9036, tanfanercept (0.25%), a tumor necrosis factor receptor 1 fragment. Phase 3 clinical trial began in March 2021. In 2022, showed improvement in signs of dry eye disease.
- Surface Ophthalmics, Kera Sol Tears for mild to moderate dry eye (over-the-counter) and Mycosol (Surf-101), which uses immunosuppressive mycophenolate for moderate to severe dry eye (in phase 3 trials).
- Aldeyra, reproxalap, a small-molecule modulator of reactive aldehyde species (RASP) in second phase 3 trial.
- Mitotech Visomitin, SkQ1, a mitochondrial-targeted antioxidant, approved in Russia. Positive topline phase 2b/3 results in U.S.
- Tear Solutions, Lacripep, a synthetic fragment of lacritin. Completed phase 1/2 study.
With approval, each one will bring a series of steak dinners where eminent speakers will tout the benefits of the new product. Each approval will bring an eye roll from our staff, wondering how onerous the prior authorization process will be. And each one may increase the sense of confusion of how it should best be used.
Nobody expects a miracle drug for dry eye anymore, but our patients deserve more than a dismissive approach to this mess of confusion. It’s easy to say AI will parse all the elements of history and physical exam that differentiate individual patients and their responses to different drugs, and it will give us its own algorithm better than we could ever divine. But how accurately do we record physical findings, and how many of us rigorously track patient-reported outcomes when we prescribe different drugs for dry eye? AI can’t draw conclusions from the non-rigorous ways we track the progress of this disease.
Until we better understand the nature of dry eye and these treatments, eminence rather than evidence-based medicine is likely to guide our treatment choices.
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Editor's note: This article was updated on June 3, 2024, to update information from Surface Ophthalmics.
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