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Clearside Biomedical shares plummet by 56% after disappointing Phase 3 results

Published on 06/11/18 at 11:39am

Shares in the US-based pharma firm Clearside Biomedical plummeted on Monday after the company announced disappointing phase III trial results for retinal vein occlusion (RVO) treatment Xipere.

The company’s share price dropped by as much as 56% after Xipere failed to meet its primary endpoint. The SAPPHIRE trial tested Xipere in combination with Regeneron Pharmaceuticals' intravitreal anti-VEGF agent Eylea (aflibercept) in comparison to Eylea monotherapy.

“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,” said Daniel White, Chief Executive Officer and President of Clearside.  “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.”

“We believe the opportunity in our primary indication, uveitis, remains very attractive.  Awareness and acceptance of the strong clinical profile of XIPERE as a potential monotherapy in treating uveitic macular edema is growing, and we remain on track to submit our NDA for this indication before the end of this year,” he added.

Louis Goss

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