Why Positive Results Just Aren't Good Enough for Clearside Bio

Health and Healthcare

Published: May 31, 2018 11:45 am

Last Updated: January 11, 2020 10:56 pm

Clearside Biomedical Inc. (NASDAQ: CLSD) shares dropped early on Thursday after the company released data from its midstage clinical trial for diabetic macular edema (DME). Specifically, this data came from the Phase 2 clinical trial (TYBEE) evaluating suprachoroidal CLS-TA used with intravitreally administered Eylea (aflibercept).

Although the trial met its primary endpoint and even its secondary endpoint, Clearside’s treatment showed inferiority to the treatment it was being combined with. This ultimately was the catalyst for investors sending the shares lower.

The trial met its primary endpoint of mean improvement in best corrected visual acuity from baseline over six months as measured using the Early Treatment of Diabetic Retinopathy Trial (ETDRS) scale. Patients in the combination arm gained an average of 12.3 ETDRS letters, compared to 13.5 ETDRS letters in the Elyea alone control arm.

Additionally, the study met a key secondary endpoint, with a mean reduction from baseline of 208 microns in central subfield thickness (CST) of the retina at six months, compared to a 177 micron mean reduction in the control arm. Also, 93% of patients in the combination arm had a greater than 50% reduction in excess CST at six months, compared to 73% in the control.

Daniel White, Clearside’s CEO and president, commented:

We are pleased with the topline results of this Phase 2 trial, which signals the potential utility of suprachoroidal CLS-TA to improve on the existing standard of care in DME, another sight-threatening disease like RVO and uveitis. Based on the TYBEE data, we believe suprachoroidal CLS-TA, when given together with an anti-VEGF agent, has potential to provide a more lasting response to treatment, thereby substantially lowering the treatment frequency and burden for DME patients.

Excluding Thursday’s move, Clearside had outperformed the broad markets, with its stock up about 106% in the past 52 weeks. In just 2018 alone, the stock was up about 108%.

Shares of Clearside were last seen down 25% at $10.93, with a consensus analyst price target of $22.60 and a 52-week trading range of $5.30 to $15.33.

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