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Shares of Oculis Holding (OCS) fell more than 23% during Friday afternoon trading after the company reported topline results from its Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in patients with diabetic macular edema (DME).
The company said the primary endpoint of the Phase 3 studies was not met.
At the time of writing, OCS shares were down 23.42%.
The DIAMOND program included two Phase 3 clinical trials testing OCS-01 eye drops in patients with diabetic macular edema (DME) over 52 weeks. More than 800 patients were enrolled across 119 study sites in the U.S. and other countries.
The main goal of the trials, which was to improve vision as measured by best corrected visual acuity, was not met in either study.
However, the treatment did show a clear benefit on a secondary measure, with OCS-01 reducing retinal thickness compared to the placebo group across both trials.
Based on the trial results, Oculis said it will not move forward with an FDA filing for OCS-01 in diabetic macular edema at this time.
Riad Sherif, M.D., Chief Executive Officer of Oculis, said, “We are naturally disappointed that the substantial and sustained reduction in retinal thickness observed across both trials didn’t translate into BCVA improvement at week 52.”
Now, the company will redirect its focus and resources to other late-stage programs, including the Privosegtor PIONEER trial for optic neuropathies and the Licaminlimab PREDICT-1 study in dry eye disease.
Stocktwits sentiment on OCS was “bullish” on Friday, unchanged in the past 24 hours. Message volume was “normal.”
OCS shares have gained 18% in the past 12 months.
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