timbetasin

Timbetasin (RGN-259) is a biologic ophthalmic solution containing a synthetic version of the naturally occurring 43-amino acid peptide thymosin beta 4 (Tβ4). Developed by ReGenTree, LLC—a joint venture between GtreeBNT and RegeneRx Biopharmaceuticals—it is primarily investigated for the treatment of dry eye syndrome and neurotrophic keratopathy. The drug's mechanism of action involves promoting corneal epithelial cell migration, reducing ocular surface inflammation, and providing cytoprotection to the ocular surface by regulating actin polymerization. It is formulated as a 0.1% sterile, preservative-free solution for topical ophthalmic administration. Although the Phase 3 ARISE-3 trial did not meet its pre-specified co-primary endpoints, the drug demonstrated significant improvements in symptoms such as ocular grittiness and has been reclassified as a Biologics License Application (BLA) candidate, potentially offering 12 years of market exclusivity upon approval.

Brand names

RGN-259RGN259RGN 259

Other names

thymosin beta 4Tβ4