FDA fast tracks urcosimod for neuropathic corneal pain

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2 Min Read

Anthony DeFino , 2025-05-01 19:53:00

Darrell E. White, MD

Patients in pain do not care about our clinical findings. They do not care about the pathophysiology underlying their pain. They do not care about the mechanism of action of the treatments we suggest. They do not care whether a treatment addresses the underlying cause(s) of their pain.

They just want the pain to stop.

Neurotrophic corneal pain (NCP) is the scourge of ocular surface disease (OSD) care, the bane of existence for doctors called upon to treat it. It is largely a diagnosis of exclusion and is associated with myriad types of OSD. Nerve damage is often present on confocal microscopy (CM), although we should caution that the lack of specificity of this clinical finding raises the possibility that it is simply a correlation.

(Note to Okyo and CEO Gary S. Jacob: Tying the diagnosis of NCP to CM findings will dramatically reduce the number of prescribers and therefore the number of patients treated.)

Urcosimod, currently in simultaneous trials for both dry eye disease and NCP, has been granted fast track designation by the FDA for its potential use in NCP. If approved, it would become our first truly effective treatment, FDA approved or not, for this debilitating condition. It may turn out that urcosimod doesn’t alter the disease state causing NCP. If it works, our patients won’t care, and neither should we.

And if it does? Put this baby on high-speed rail, destination: cornea.


Disclosures: White reports speaking and consulting for Allergan, Bausch + Lomb, Sun, Tarsus and Viatris, consulting for Aldeyra, Bruder, Nordic Pharma and Thea, and consulting for and being an investor in Orasis and SpyGlass.

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