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Neurotrophic Keratopathy(NK)

What is Neurotrophic Keratopathy?

  • NK is a degenerative disease characterized by decreased corneal sensitivity and poor corneal healing. This disorder makes the cornea sensitive to injury and decreases reflex tearing. Moreover, epithelial breakdown can lead to ulceration, infection, melting, and perforation. Typical characteristics of neurotrophic keratopathy are a decrease or loss in corneal sensitivity and poor ocular wound healing.
  • Currently developing Tβ4 as a treatment for neurotrophic keratopathy
  • Received an orphan drug designation from the USA FDA for neurotrophic keratopathy.
  • Until now, there have been no effective treatments for NK. Development of RGN-259 is expected to provide a new therapeutic treatment for patients who are suffering from this disorder.

Development stage

* RELATED INFORMATION
   http://www.ncbi.nlm.nih.gov/pubmed/20536469
   http://www.ncbi.nlm.nih.gov/pubmed/20457990
   https://www.clinicaltrials.gov/ct2/show/NCT02600429?term=neurotrophic+keratopathy&rank=1
   https://www.clinicaltrials.gov/study/NCT05555589?term=seer-2&rank=1

  • Received orphan drug designation from the USA FDA.
  • Concluded contract with Ora, Inc., a CRO company that specializes in ophthalmic diseases for conducting Phase III clinical trial.
  • Conducting two Phase III clinical trials(SEER-2 & SEER-3) of RGN-259 for treatment of Neurotrophic Keratopathy in the US and EU
  • Manufactured investigational products in a USA FDA cGMP-certified CMO

Specificity

  • Tβ4 has various mechanisms of actions for the treatment of neurotrophic keratopathy which is a multifactorial disease. Tβ4 is priming the pump of the corneal wound healing process during the early phases of healing. This may include up- and/or downregulation of cytokines, chemokines, and neuropeptides that promote wound healing, modulation of limbal stem cell differentiation and migration, stimulation of corneal epithelial cell migration by various signal transduction pathways.
  • There are currently no specific prescription drugs for treating neurotrophic keratopathy beyond anti-inflammatory agents.
  • RGN-259 is being developed as a new prescription drug. Since there are no competitive products launched to treat neurotrophic keratopathy, the market demand for a new drug is very high.

Market territory

  • ReGenTree has exclusive rights for the development and commercialization of RGN-259 in Worldwide (Other than China, Hong Kong, Taiwan).

Please contact HLB Therapeutics if you are interested in partnering (other than China, Hong Kong, Taiwan).