What is Neurotrophic Keratitis?
Neurotrophic keratitis is a degenerative disease characterized by reduced corneal sensation and poor corneal healing. The decrease or loss of corneal sensation and damage to corneal epithelial cells can cause ulcers, infections, melting, and perforation. Surgical procedures, such as sealing the upper and lower eyelids to prevent emergencies and rapid infection during the onset of this rare disease, are the only available therapeutic options. (e.g. Conjunctival flap, Therapeutic contact lens Keratoplasty, Amniotic membrane transplantation)
Development Stage
· RGN-259: Sterile, preservative-free eye drops containing Thymosin Beta 4 (timbetasin)
· Ongoing Phase 3 clinical trial (SEER-1) of RGN-259 for neurotrophic keratitis being conducted by ReGenTree, LLC, a US joint venture
· Designated as an orphan drug for the treatment of neurotrophic keratitis by the US FDA
Clinical Information
SEER-1 (Phase 3) : https://www.clinicaltrials.gov/ct2/show/NCT02600429
Paper related to results of the investigator-initiated trial : https://www.ncbi.nlm.nih.gov/pubmed/20536469
Scientific paper related to wound healing: https://www.ncbi.nlm.nih.gov/pubmed/11950239
Scientific paper related to promotion of cell migration: https://www.ncbi.nlm.nih.gov/pubmed/12324865
NK (Neurotrophic Keratopathy) Clinical trial name: SEER (Safety and Efficacy Examination of RGN-259)