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Clearside Biomedical Plunges 60% Following Phase 3 Study Results

Clearside Biomedical Plunges 60% Following Phase 3 Study Results

Shares of Clearside Biomedical Inc (NASDAQ: CLSD), a biopharmaceutical company that focuses on the treatment of serious eye diseases, plunged 60 percent Monday after announcing disappointing results from a Phase 3 study.

What Happened

Clearside said in a press release its Phase 3 clinical trial called SAPPHIRE for the treatment of patients with retinal vein occlusion (RVO) failed to achieve its primary endpoint. The purpose of the study was to evaluate the superiority of its XIPERE therapy used in combination with Eylea compared to Eylea as a monotherapy.

The company said around 50 percent of patients in both arms showed at least a 15 letter improvement in vision. However, there was no observable additional benefit for patients receiving its XIPERE together with Eylea.

Why It's Important

Due to the results in the clinical trial, the company will discontinue clinical development of combination therapy for RVO, including the SAPPHIRE study and its companion Phase 3 clinical trial TOPAZ.

What's Next

Despite a setback in the clinical study, Clearside CEO and President Daniel White said the opportunity in its primary indication, unveitis, remains very attractive. The company remains on track to submit a New Drug Application (NDA) for the indication before the start of 2019.

The stock fell more than 60 percent to $2.11 per share at time of publication.

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