SY-201
SY-201 is a small peptide that regulates the immune and tissue homeostasis of ocular surface tissues by modulating the metabolic pathways and mitochondrial functions of immune cells and epithelial cells. It promotes goblet cell proliferation and mucin production, enhancing tear film stability and restoring the crucial lubricating and moisturizing functions of tears. Additionally, SY-201 facilitates the generation of intracellular reductants, counteracting cellular damage from free radicals and buffering oxidative stress. It also inhibits oxidative stress-induced apoptosis. Lastly, SY-201 promotes the expression and proliferation of tight junction proteins such as junctional adhesion molecules and claudins in corneal tissue, maintaining the balance between proliferation and differentiation of corneal epithelial cells, preserving corneal tissue integrity, and sustaining the barrier function of the cornea.
The therapeutic effect of SY-201 has been investigated in mouse models of dry eye. Results demonstrated that SY-201 reduced ocular surface damage, decreasedcorneal and conjunctival epithelium keratinization, reduced expression of MMP-3 and MMP-9, promoted proliferation of ocular surface epithelial cells, decreased ocular surface cell apoptosis, decreased infiltration of CD4+ T cells in the conjunctiva and increased expression of anti-inflammatory cytokine IL-13 which is known to be important for tissue repair, goblet cell proliferation, and mucin function.
The results of two Investigator-Initiated Trials (IITs) conducted in China show that after two or four weeks of treatment with SY-201, patients with dry eye disease experienced a significant decrease in their OSDI (Ocular Surface Disease Index) scores, a notable increase in their TBUT (Tear Break-Up Time), and a substantial reduction in their CFS (Corneal Fluorescein Staining) scores.
The Phase 2 double-masked, randomized, parallel, vehicle-controlled clinical trial in the United States has been completed (NCT05370495).
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