{"id":526239,"date":"2021-08-10T16:10:42","date_gmt":"2021-08-10T20:10:42","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/clearside-biomedical-announces-second-quarter-2021-financial-results-and-provides-corporate-update\/"},"modified":"2021-08-10T16:10:42","modified_gmt":"2021-08-10T20:10:42","slug":"clearside-biomedical-announces-second-quarter-2021-financial-results-and-provides-corporate-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/clearside-biomedical-announces-second-quarter-2021-financial-results-and-provides-corporate-update\/","title":{"rendered":"Clearside Biomedical Announces Second Quarter 2021\u00a0Financial Results and Provides Corporate Update"},"content":{"rendered":"
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\n – Enrollment Underway in Cohort 2 of OASIS Wet AMD <\/em>
\n Phase 1\/2a <\/em>
\n Trial\u00a0<\/em>
\n with Data Expected by the End of 2021 \u2013<\/em>
\n \n <\/p>\n

\n – Upcoming FDA PDUFA Action Date in October 2021 for XIPERE\u2122<\/em>
\n \u00a0<\/em>
\n (triamcinolone acetonide suprachoroidal injectable suspension) –<\/em>\n <\/p>\n

\n – Management to Host Webcast and Conference Call Today at 4:30 P.M. ET –<\/em>\n <\/p>\n

ALPHARETTA, Ga., Aug. 10, 2021 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc.\u00a0(NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for second quarter ended June 30, 2021.<\/p>\n

\u201cWe continue to demonstrate our position as the leader in the suprachoroidal space with numerous clinical trials in multiple indications, a New Drug Application (NDA) for XIPERE\u2122\u00a0under regulatory review and recent positive results from our CLS-AX clinical trial,\u201d said George Lasezkay, Pharm.D., J.D., Clearside\u2019s President and Chief Executive Officer. \u201cWe are the first company to develop a clinically tested, non-surgical, repeatable micro-injection technology designed to unlock the potential clinical benefits of administering drugs into the suprachoroidal space. We are encouraged by the Cohort 1 results of our OASIS Phase 1\/2a trial in wet AMD patients, which achieved its safety and tolerability endpoints. We believe the Cohort 1 data supports our hypothesis that the combination of targeted and compartmentalized suprachoroidal delivery and the potent pan-VEGF attributes of axitinib may facilitate an effective treatment option for patients suffering from wet AMD. We have begun enrollment in Cohort 2 with more than triple the dose used in Cohort 1 and look forward to reporting results by the end of 2021.\u201d<\/p>\n

\u201cFollowing our NDA resubmission for XIPERE for the treatment of macular edema associated with uveitis, the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) action date of October 30, 2021. If approved, XIPERE would represent the first therapy for macular edema associated with uveitis, the first approved therapeutic delivered into the suprachoroidal space and the first commercial product developed by Clearside. In addition to progressing our internal development initiatives, we continue to work closely with our commercial and drug development partners, and expect data from their ongoing clinical trials using our SCS Microinjector\u00ae<\/sup> later this year,\u201d concluded Dr. Lasezkay.<\/p>\n

\n Key Highlights<\/strong>\n <\/p>\n