March 5, 2018 / 12:14 PM / in 6 months

BRIEF-Clearside Biomedical Announces Results From Phase 3 Trial Of CLS-TA

March 5 (Reuters) - Clearside Biomedical Inc:

* CLEARSIDE BIOMEDICAL ANNOUNCES POSITIVE TOPLINE RESULTS FROM PIVOTAL PHASE 3 CLINICAL TRIAL OF CLS-TA IN MACULAR EDEMA ASSOCIATED WITH NON-INFECTIOUS UVEITIS

* PRIMARY ENDPOINT ACHIEVED IN PHASE 3 CLINICAL TRIAL OF CLS-TA

* ALL KEY SECONDARY ENDPOINTS ACHIEVED IN STUDY

* STATISTICALLY SIGNIFICANT IMPROVEMENT IN PROPORTION OF PATIENTS GAINING 15 OR MORE LETTERS IN VISUAL ACUITY IN STUDY

* SUPRACHOROIDAL CLS-TA WAS GENERALLY WELL TOLERATED, WITH NO TREATMENT-RELATED SERIOUS ADVERSE EVENTS REPORTED IN TRIAL

* EXPECT TO SUBMIT NDA FOR SUPRACHOROIDAL CLS-TA IN PATIENTS WITH MACULAR EDEMA ASSOCIATED WITH UVEITIS TO FDA IN Q4 2018

* EVALUATING OPTIONS FOR SUBMISSIONS TO REGULATORY AGENCIES IN TERRITORIES OUTSIDE OF U.S. FOR SUPRACHOROIDAL CLS-TA Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below