Cyclosporine A has been used to treat dry eye syndrome since 2003 (Restasis®). However, due to its poor water solubility, commercial formulations often require large amounts of surfactants or oils. These additives are known to cause side effects—such as burning, stinging, and redness—in approximately 20% of patients.

 

SCAI-001 is a novel physical nano-assembly of cyclosporine A, developed without chemical modification or additional solubilizing agents. It is formulated using the same excipients as Restasis® but with significantly reduced levels of surfactants and emulsifiers.

 

In preclinical studies, SCAI-001 demonstrated enhanced ocular permeability and excellent efficacy in animal models.

In Phase 2 clinical trials, SCAI-001 eye drops showed dose-dependent improvements in both signs and symptoms of dry eye syndrome, while maintaining a safety and tolerability profile comparable to Restasis®—even at lower doses of cyclosporine A.

 

SCAI-001 has strong potential to offer an effective and well-tolerated treatment alternative with a simplified formulation.

 

We are currently seeking a strategic partner to advance SCAI-001 into Phase 3 clinical development.

 

 

SCAI-001 showed better bioavailability vs Restasis® in PK studies with NZW rabbits.

SCAI-001 0.01% showed higher exposure in the cornea and conjunctiva compared to Restasis® 0.05%, which explains the improved efficacy of SCAI-001.

 

 

 

SCAI-001 has a distinct appearance compared to Restasis.

While SCAI-001 is a translucent solution, Restasis is a milky suspension.