Clearside Biomedical Inc. (NASDAQ: CLSD) shares dropped sharply early on Monday after the firm reported results from its late-stage Sapphire trial. Ultimately, the Phase 3 results did not achieve the primary endpoint for the treatment of retinal vein occlusion (RVO).
The primary endpoint of this trial was the proportion of patients in the combination treatment arm, compared to the intravitreal Eylea-alone control arm, with improvements in best corrected visual acuity from baseline of at least 15 letters on the Early Treatment Diabetic Retinopathy Study scale at eight weeks after initial treatment.
Daniel White, CEO and president of Clearside, commented:
In the Sapphire trial, approximately 50% of patients in both arms showed at least a 15 letter improvement in vision; unfortunately, there was no additional benefit for patients receiving Xipere together with intravitreal Eylea. In light of these 8-week topline data, we plan to discontinue clinical development of combination therapy for RVO, which includes Sapphire and its companion Phase 3 clinical trial, Topaz.
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Excluding Monday’s move, Clearside Bio had underperformed the broad markets, with its stock down 19% in the past 52 weeks. In just 2018 alone, the stock was down closer to 21%.
Shares traded down more than 57% Monday morning to $2.38. The consensus analyst price target is $23.00, and the stock has a 52-week range of $5.03 to $15.33.
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