The trial’s primary endpoint was the proportion of patients in the combination treatment arm, compared to the group receiving just intravitreal Eylea, that experienced improvements in best corrected visual acuity after eight weeks.
A similar proportion of patients in both arms of the 460-patient Sapphire trial gained at least 15 letters in BCVA after eight weeks, according to Clearside Biomedical.
“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,” president & CEO Daniel White said in prepared remarks. “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 III 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,” White added.
CLSD shares tumbled -51% in premarket activity today, down to $2.70 apiece.