Exhibit 99.1

 

 

Clearside Biomedical Announces First Quarter 2018 Financial Results and Provides Corporate Update

 

ALPHARETTA, GA, May 9, 2018 (GLOBE NEWSWIRE) – Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage clinical biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today reported financial results for the quarter ended March 31, 2018, and provided an update on its development programs.

 

“Coming on the heels of the recent release of positive topline results from our pivotal Phase 3 PEACHTREE trial in uveitis, and as we have continued to accumulate additional data from the trial around the resolution of signs and symptoms, our confidence in the potential of suprachoroidal CLS-TA to become a powerful new treatment option for this sight-threatening disease, both at home and abroad, continues to build,” said Daniel H. White, Chief Executive Officer and President.  “To that end, we are working to submit an NDA for suprachoroidal CLS-TA in patients with macular edema associated with uveitis to the FDA before the end of the year, and we are also evaluating our regulatory submission strategy for territories outside of the United States.”

 

Update on Key Development Programs

 

Suprachoroidal CLS-TA is Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide for administration to the back of the eye via the suprachoroidal space (“SCS™”), which is the space located between the choroid and the outer protective layer of the eye known as the sclera.  Suprachoroidal CLS-TA, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline of treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the retina and the choroid.

 

Macular Edema Associated with Non-Infectious Uveitis

 

In March 2018, Clearside announced positive topline results from PEACHTREE, its pivotal Phase 3 trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis.  

 

In the PEACHTREE trial, 47% of patients in the treatment arm who received suprachoroidal CLS-TA every 12 weeks gained at least 15 letters in best corrected visual acuity (“BCVA”), as measured using the Early Treatment of Diabetic Retinopathy Study (“ETDRS”) scale, from baseline at week 24, compared to 16% of patients in the control arm who underwent a sham procedure.  This improvement, which was the primary endpoint of the trial, was statistically significant (p < 0.001).  Further, in terms of improvements in BCVA, the mean change from baseline was better in the treatment arm than in the control arm at each monthly evaluation. The mean improvement from baseline seen at the first evaluation at week 4 was maintained throughout the trial, with 9.6 letters gained at week 4 and 13.7 letters at week 24 in the treatment arm, compared to 1.2 letters at week 4 and 2.9 letters at week 24 in the control arm. For the other key secondary endpoint, administration of suprachoroidal CLS-TA resulted in a mean reduction from baseline

 

 


The following information was filed by Clearside Biomedical, Inc. (CLSD) on Wednesday, May 9, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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