TUL12101 (cyclosporine)

TUL12101 is a 0.05% cyclosporine ophthalmic gel developed by Zhuhai Federal Pharmaceutical (The United Laboratories) for the treatment of dry eye disease (keratoconjunctivitis sicca). Cyclosporine is a cyclic peptide that functions as a potent immunosuppressive agent by inhibiting calcineurin. Upon topical administration, cyclosporine binds to the intracellular protein cyclophilin A to form a complex that subsequently inhibits the phosphatase activity of calcineurin. This inhibition prevents the dephosphorylation and nuclear translocation of the nuclear factor of activated T-cells (NFAT), thereby blocking the transcription of pro-inflammatory cytokines such as interleukin-2 (IL-2). By reducing T-cell-mediated inflammation on the ocular surface and within the lacrimal glands, TUL12101 helps to restore natural tear production and improve ocular surface integrity. The gel formulation is specifically designed to enhance ocular residence time and patient comfort compared to traditional oil-based emulsions. TUL12101 received marketing approval from the China National Medical Products Administration (NMPA) in June 2024.

Other names

Cyclosporine Ophthalmic GelCyclosporine A Ophthalmic Gelcyclosporine A