Opthea

38 articles with Opthea

• Opthea’s OPT-302 Granted FDA Fast Track Designation for Wet Age-Related Macular Degeneration

  7/6/2021

  Opthea Limited, a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, is pleased to announce that the U.S. Food and Drug Administration has granted Fast Track designation for the company’s VEGF-C/-D ‘trap’ inhibitor, OPT-302, in combination with anti-VEGF-A therapy for the treatment of patients with neovascular age-related macular degeneration.

• Opthea Appoints Company Secretary and Vice President of Finance

  6/14/2021

  Opthea Limited, a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, is pleased to announce the appointment of Mrs. Karen Adams as Vice President of Finance and Company Secretary, effective June 12, 2021.

• Opthea Appoints Julia A. Haller, MD, and Judith Robertson to Board of Directors

  6/1/2021

  Opthea Limited, a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, is pleased to announce the appointments of Dr. Julia Haller and Ms. Judith Robertson as independent Non-Executive Directors to its Board of Directors, effective June 1, 2021.

• Opthea Company Secretary Resignation

  4/6/2021

  Opthea Limited advises that Mr Michael Tonroe has resigned as Company Secretary and Chief Financial Officer of the Company, with effect 24 June 2021.

• Opthea Receives FDA Waiver for Pediatric Study Plan for OPT-302 in Wet AMD

  3/31/2021

  Opthea Limited announces that it has received an initial Pediatric Study Plan waiver from the US Food and Drug Administration for OPT-302, the Company’s lead product candidate currently in Phase 3 clinical development for the treatment of neovascular age-related macular degeneration.

• Opthea Treats First Patient in Phase 3 Pivotal Trials of OPT-302 in Wet AMD

  3/15/2021

  Opthea Limited, a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce that the first patient has been treated in the Phase 3 pivotal clinical program of the Company’s first-in-class VEGF-C/D ‘trap’ inhibitor, OPT-302, in participants with treatment-naïve wet age-related macular degeneration.

• Opthea to Present at the Oppenheimer 31st Annual Healthcare Conference

  3/10/2021

  Opthea Limited, a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, announced that Dr Megan Baldwin, CEO of Opthea, will virtually present and provide a corporate update at the Oppenheimer 31st Annual Healthcare Conference on Tuesday, March 16, 2021 at 3:50pm ET.

• Opthea Finalizes Study Designs and Start-up Activities for Phase 3 Pivotal Clinical Trials of OPT-302 in Wet AMD

  2/24/2021

  Following consultations with US FDA and EU EMA, two pivotal Phase 3 clinical trial designs are finalized to assess 2 mg OPT-302 administered 4-weekly or 8-weekly in combination with Lucentis® (ShORe study) and Eylea® (COAST study) standard of care

• Opthea to Present at the 10th Annual SVB Leerink Global Healthcare Conference

  2/17/2021

  Opthea Limited, a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, announced that Dr Megan Baldwin, CEO of Opthea, will virtually present and provide a corporate update at the 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24, 2021 at 3:40pm ET.

• Opthea Announces Pricing of Initial Public Offering in the United States

  10/16/2020

  Opthea Limited (ASX:OPT, Nasdaq: OPT), a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, today announces the pricing of its initial public offering in the United States (the “Offering”) of 8,563,300 American Depositary Shares (“ADS”), representing 68,506,400 ordinary shares, at an initial public offering price of US$13.50 per ADS, before underwriting discounts

• Opthea Announces Launch of Proposed Initial Public Offering in the United States - Oct 12, 2020

  10/12/2020

  Opthea Limited, a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, announces the launch of its initial public offering of American Depositary Shares, each of which will represent eight of the Company’s ordinary shares, in the United States.

• Opthea to Appoint Dr Jeremy Levin as Chairman of the Board

  10/5/2020

  Opthea Limited, a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce that Jeremy Levin, DPhil, MB BChir will be appointed to the Company’s Board of Directors, effective October 12, 2020.

• Opthea Files Registration Statement for Proposed Initial Public Offering in the United States

  9/25/2020

  Opthea Limited announces the public filing of a registration statement on Form F-1 with the U.S. Securities and Exchange Commission relating to a proposed public offering of American Depositary Shares, each of which will represent one or a number of the Company’s ordinary shares in the United States.

• Opthea Announces Plans to Conduct Registered Public Offering and Listing in the United States

  8/24/2020

  Opthea Limited announces that it has confidentially submitted a draft registration statement on Form F-1 to the U.S. SEC relating to a potential initial public offering of American Depositary Shares in the U.S. representing Opthea’s ordinary shares, which will remain listed on the Australian Securities Exchange, and concurrent listing of the ADSs on the Nasdaq Stock Market.

• Opthea Completes Successful Meetings with FDA and EMA for OPT-302 Phase 3 Clinical Program in Wet AMD

  8/21/2020

  Regulatory engagement provides clear pathway through Phase 3 to support filing for marketing approvals in US and Europe Regulatory agreement of using Lucentis ® and Eylea ® in combination with OPT-302 across two pivotal Phase 3 trials increases the potential multi-billion dollar market opportunity Lucentis ® and Eylea ® had combined sales for retinal diseases of USD11.9BN in 2019  Company on-track to initiate Phase 3 trials in early 2021        

• Opthea to Host Wet AMD and DME Key Opinion Leader Symposium on August 5, 2020 (EDT)

  7/28/2020

  Opthea Limited is pleased to announce that it will host a Key Opinion Leader symposium focused on OPT-302, the Company’s first-in-class biologic inhibitor of VEGF-C/D, in development for the treatment of wet age-related macular degeneration and diabetic macular edema.

• Opthea Reports New Data of OPT-302 in Diabetic Macular Edema at the 2020 Annual Meeting of the American Society of Retina SpecialistsCompany to host Key Opinion Leader Symposium on Wet AMD & DME on Aug 5th, 7:00pm EDT

  7/27/2020

  Opthea Limited, a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce that new data from the Phase 1b/2a clinical study of OPT-302 in patients with treatment refractory diabetic macular edema has been presented at the 2020 American Society of Retina Specialists Virtual Annual Meeting.

• Opthea Clinical Data of OPT-302 in Diabetic Macular Edema to be Presented at American Society of Retina Specialists 2020 Annual Meeting

  7/23/2020

  Opthea Limited, a clinical stage biopharmaceutical company developing a novel therapy to treat highly prevalent and progressive retinal diseases, is pleased to announce that clinical trial results from the Phase 1b/2a study of OPT-302 in diabetic macular edema patients refractory to anti-VEGF-A therapy, will be presented at the upcoming American Society of Retina Specialists Annual 2020 Virtual Annual Meeting.

• Opthea Completes Patient Dosing in Phase 2a DME TrialCompany also provides business update in response to COVID-19

  3/30/2020

  Opthea Limited, a clinical stage biopharmaceutical company developing novel biologic therapies to treat eye diseases, has completed patient dosing and all follow-up week 12 patient visits in the Company’s Phase 2a trial evaluating the safety and efficacy of OPT-302 administered in combination with aflibercept for treatment of diabetic macular edema.

• Opthea to Present at the 9th Annual SVB Leerink Global Healthcare Conference

  2/18/2020

  Opthea Limited announced that Dr Megan Baldwin, CEO of Opthea, will present and provide a corporate update at the 9th Annual SVB Leerink Global Healthcare Conference on February 25, 2020 at 11am EST in New York City.