Skip to main content

Market Overview

Clearside Biomedical Shares Soar On Encouraging Safety Profile For Injectable Axitinib In Wet AMD Patients

Share:
Clearside Biomedical Shares Soar On Encouraging Safety Profile For Injectable Axitinib In Wet AMD Patients
  • Clearside Biomedical Inc (NASDAQ: CLSDhas announced positive safety results from Cohort 1 (n=6) of OASIS Phase 1/2a trial of CLS-AX (axitinib injectable suspension) for neovascular age-related macular degeneration (wet AMD).
  • The primary endpoints were achieved, as the initial lowest planned dose of 0.03 mg CLS-AX was well-tolerated with no serious adverse events, drug-related treatment-emergent adverse events observed.
  • There were no signs of inflammation, no vasculitis, no intraocular pressure safety signals, no dispersion of drug into the vitreous, or any other drug-related adverse events observed in any of the patients.
  • One month after receiving CLS-AX, five of six patients exhibited improvement in BCVA, each gaining four or more letters, with the mean ETDRS BCVA score of all patients increasing by +4.7 letters.
  • In Cohort 1, no patients required additional treatment with Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) Eylea (aflibercept) at the one-month visit after CLS-AX.
  • Two patients went three months after CLS-AX without additional treatment with aflibercept, and BCVA improved by 5 and 7 ETDRS letters for these patients.
  • Four patients received additional treatment with aflibercept at the two-month visit after CLS-AX.
  • The trial will advance to Cohort 2, with patient screening for a dose of 0.1 mg to start in June, with completion expected by the end of the year.
  • Price Action: CLSD shares are up 56.3% at $4.72 during the premarket session on the last check Tuesday.
 

Related Articles (REGN + CLSD)

View Comments and Join the Discussion!

Posted-In: Biotech Long Ideas News Penny Stocks Health Care FDA Movers Trading Ideas

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com