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Clearside Biomedical, Inc. Announces Second Quarter 2017 Financial Results and Provides Corporate Update
ALPHARETTA, GA, August 9, 2017 (GLOBE NEWSWIRE) – Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today reported financial results for the quarter and six months ended June 30, 2017 and provided an update on its development programs.
“Clearside’s pursuit of transformative, elegant, precise solutions to restore and preserve vision resulted in the achievement of a number of recent key milestones,” said Daniel H. White, Chief Executive Officer and President. “Noteworthy among those was completion of patient enrollment in our pivotal Phase 3 trial for the treatment of macular edema associated with non-infectious uveitis, Clearside’s most advanced clinical development program, and the enrollment of the first patient in our Phase 3 trial for the treatment of patients with macular edema associated with retinal vein occlusion.”
CLS-TA for suprachoroidal administration (“suprachoroidal CLS-TA”), Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide, is part of Clearside’s pipeline of potential treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina. Suprachoroidal CLS-TA is being studied for potential administration both alone and together with an intravitreal anti-VEGF agent.
Macular Edema Associated with Non-Infectious Uveitis
In early August 2017, Clearside completed patient enrollment in PEACHTREE, the pivotal Phase 3 trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis. Patient follow-up in PEACHTREE will continue for 6 months after initial treatment. Accordingly, Clearside expects to report top-line results from the trial in the first quarter of 2018.
Macular Edema Associated with Retinal Vein Occlusion (“RVO”)
On June 8, 2017, Clearside announced that, at the 40th Annual Macula Society Meeting, Charles C. Wykoff, M.D., Ph.D. presented preliminary results from a non-interventional trial (the “Extension Study”) of patients who had participated in the completed Phase 2 clinical trial (“TANZANITE”) of suprachoroidal CLS-TA used together with intravitreally administered EYLEA® (aflibercept) (“intravitreal Eylea”) for the treatment of RVO. Based on the small number of patients in the TANZANITE trial’s combination arm that received additional retreatment, the substantial unmet need associated with frequent office visits and injections required in this patient population, and after feedback from investigators, Clearside performed a retrospective analysis of patient charts that included 3 months from the TANZANITE trial and at least a 6-month follow-on period to more thoroughly assess the duration of effect of the combination treatment and the potential to reduce the burden of therapy. In the analysis presented by Dr. Wykoff, 17 of the 23 patients in the combination arm of the TANZANITE trial, or 74%, did not receive any additional treatment over the 9-month time frame, compared to only 4 of 23 patients, or 17%, in the Eylea-only arm during that same period of time who did not need further treatment.
The following information was filed by Clearside Biomedical, Inc. (CLSD) on Wednesday, August 9, 2017 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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