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Multiple SEC filings made prior to the stock collapse continued to present the OCS-01 DME program as progressing toward regulatory approval. A prospectus supplement filed on October 31, 2025 stated that topline results from the DIAMOND trials were “expected in the second quarter of 2026,” with a subsequent New Drug Applications (NDAs) submission to the U.S. FDA to begin in Q4 2026. A 6-K filed on October 6, 2025 described Oculis as being “in a strong position with multiple pivotal studies, targeting multi-billion-dollar markets” in connection with the DME program.
The Company ultimately disclosed that the pivotal DIAMOND trials failed and announced it would abandon the FDA filing for DME entirely. Oculis stock fell over 23% on the announcement.