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Clearside Biomedical shares slide after failed Phase 3 trial, but a plan B is in the works

Its Phase 3 clinical trial of eye disease drug Xipere failed to meet its primary endpoint
Equipment in an ophthalmologist's office
Clearside Biomedical develop treatments to restore and preserve vision for people with eye diseases

Clearside Biomedical Inc (NASDAQ:CLSD) shares tanked after its Phase 3 clinical trial didn’t go according to plan.

Shares of the Georgia-based biopharma fell nearly 50% to $2.90 in Monday pre-market trading.

Its clinical trial known as SAPPHIRE was looking at the effects of its drug Xipere in patients with retinal vein occlusion, which occurs when there is a blockage of the veins that carry blood away from the retina.

Patients received a combination of Xipere and Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) Eylea or just Xipere on its own.

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The study found that about half of the participants showed at least a 15-letter improvement in vision with no additional benefit found for those who received both drugs.

The biopharma said it will discontinue its clinical development of Xipere for patients with retinal vein occlusion and will stop its companion Phase 3 TOPAZ study.

However, all hope isn’t lost. The company highlighted Xipere’s potential to treat uveitic macular edema, a condition that occurs when the retina thickens in the macular area of the eye due to the breakdown of the blood-retinal barrier, as per a paper by The Royal College of Ophthalmologists.

CEO Daniel White said in a press release that the biopharma plans to submit its New Drug Application to the US Food and Drug Administration before the end of the year.

Clearside Biomedical develop treatments to restore and preserve vision for people with eye diseases.

 

Contact Lenore Fedow at [email protected]

Follow her on Twitter@LenoreMariee



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