Oculis Holding AG | Johnson Fistel

Oculis Holding AG Shareholders Are Encouraged to Reach Out to Johnson Fistel for More Information about Potentially Recovering Their Losses

Johnson Fistel, PLLP is investigating whether Oculis Holding AG (NASDAQ: OCS) or certain of its executive officers violated federal securities laws. The investigation focuses on investors’ losses and whether they may be recovered under federal securities laws.

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Or for more information, contact Jim Baker at jimb@johnsonfistel.com or (619) 814-4471.

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Background of the Investigation

Oculis is a global biopharmaceutical company focused on ophthalmology and neuro-ophthalmology. The Company’s lead ophthalmology candidate, OCS-01, is an investigational topical eye-drop therapy being evaluated for diabetic macular edema (“DME”).

The investigation concerns whether Oculis and certain of its executives misled investors regarding the risks facing the Company’s Phase 3 DIAMOND program for OCS-01. On January 14, 2026, Oculis’s Chief Executive Officer discussed OCS-01 at the J.P. Morgan Healthcare Conference and stated, among other things, “This product, we know that it works,” and that “the only risk, which always remains till the last moment of a study is execution.” During that same discussion, Oculis also identified visual-function endpoints, including best corrected visual acuity (“BCVA”) and responder analyses, as the regulatory endpoints relevant to the FDA, while stating that central macular thickness was not a regulatory endpoint.

On April 20, 2026, Oculis announced that the last patient visits for both Phase 3 DIAMOND trials had been completed and that topline results were expected in June 2026. The Company stated that, if the results were positive, it expected to prepare for a planned New Drug Application submission to the FDA later in 2026.

On May 11, 2026, Oculis reported its first quarter 2026 financial results and stated that its pipeline was “advancing as planned,” that the DIAMOND data readout remained on track, and that the Company had begun 2026 with “strong execution momentum across our late-stage clinical trials.”

Then, on May 29, 2026, Oculis announced topline results from the Phase 3 DIAMOND-1 and DIAMOND-2 trials. The Company disclosed that both trials failed to meet the primary endpoint of mean change in BCVA at Week 52 and also failed to meet the key secondary endpoint measuring the proportion of patients with a gain of at least 15 letters in BCVA. Although Oculis reported reductions in retinal thickness, the Company stated that those anatomical effects did not translate into the visual-function improvements required by the trials. Oculis further disclosed that, based on the results, it did not plan to pursue an FDA regulatory filing for OCS-01 in DME at that time.

Following this disclosure, Oculis’s stock price declined sharply.

The investigation focuses on whether Oculis misrepresented the material risks facing OCS-01 by portraying execution as the principal remaining risk while allegedly failing to disclose that the Company’s FDA-relevant efficacy endpoints remained subject to significant risk. After the failed topline results, Oculis stated that trial execution was not the problem. Instead, the Company disclosed that the approval-critical BCVA and responder endpoints were not achieved.

In light of this disclosure, Johnson Fistel is investigating whether Oculis complied with state and federal laws, including the federal securities laws. If you suffered losses, or are a long-term holder of Oculis stock, contact Johnson Fistel.

About Johnson Fistel, PLLP | Securities Fraud & Investor Rights
Johnson Fistel, PLLP is a nationally recognized shareholder rights law firm with offices in California, New York, Georgia, Idaho, and Colorado. The firm represents individual and institutional investors in shareholder class actions and derivative lawsuits. Johnson Fistel has been recognized as one of the Top 10 Plaintiff Law Firms by ISS Securities Class Action Services. In 2024, the firm recovered approximately $90,725,000 for investors.

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Johnson Fistel, PLLP
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James Baker, Investor Relations – or – Frank J. Johnson, Esq.
(619) 814-4471 | jimb@johnsonfistel.com | fjohnson@johnsonfistel.com