Posted by Oculis’s most advanced product candidate, OCS-01, is currently in Phase 3 development and aims to be the first eye drop for diabetic macular edema (DME). In the U.S. alone, the diagnosed DME population is estimated to be around 1.8 million1 and currently represents a ~$3 billion market opportunity with high unmet medical needs for early intervention and for patients with inadequate response to standard of care, which could be addressed with OCS-01 eye drops, if approved. Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission to the FDA planned for Q4 2026.
OCS-01 provides a high concentration of dexamethasone in a solubilising nanoparticle (SNP) aggregate formulation. Novel SNP-based formulations have been shown to achieve better penetration over longer periods of time by creating smartly crafted drug–cyclodextrin complexes that create a highly concentrated drug suspension that is able to deliver the drug for a prolonged period.