OPT Opthea Limited

6.58
-0.95  -13%
Previous Close 7.53
Open 7.51
52 Week Low 6.405
52 Week High 16.23
Market Cap $277,728,778
Shares 42,208,021
Float 42,208,021
Enterprise Value $177,838,622
Volume 18,014
Av. Daily Volume 138,889
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Upcoming Catalysts

Drug Stage Catalyst Date
OPT-302
Wet age-related macular degeneration (AMD)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
OPT-302
Diabetic macular edema
Phase 1/2
Phase 1/2
Phase 2a trial completed.

Latest News

  1. MELBOURNE, Australia, July 06, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT), 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 (FDA) 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 (wet) age-related macular degeneration (AMD).

    The FDA's Fast Track program offers a number of benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of getting important new…

    MELBOURNE, Australia, July 06, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT), 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 (FDA) 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 (wet) age-related macular degeneration (AMD).

    The FDA's Fast Track program offers a number of benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of getting important new therapies to patients more quickly. This Fast Track designation acknowledges the significant unmet medical need in the management of neovascular AMD, and the potential role that OPT-302 may have in addressing it.

    With the Fast Track designation, Opthea is eligible for more frequent regulatory meetings and communications with the FDA, as well as a Rolling Review of completed sections of its Biologic Drug Application (BLA) which will help expedite the Phase 3 development program and subsequent approval review process. Under the Fast Track designation, OPT-302 may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

    "Given the need to improve therapeutic options for wet AMD patients, we welcome this Fast Track designation for OPT-302 and the regulatory support it provides in expediting the Phase 3 development program to advance this promising novel treatment to patients sooner," commented Dr. Megan Baldwin, Chief Executive Officer and Managing Director of Opthea. "The recognition from the FDA to grant OPT-302 Fast Track designation reflects the seriousness of wet AMD as a debilitating eye disease and the importance of advancing new therapies such as OPT-302 to address the significant unmet medical need for wet AMD patients, many of whom experience an incomplete response to VEGF-A inhibitors despite regular, ongoing therapy. By targeting a novel mechanism of action, OPT-302 has the potential to be a truly differentiated treatment option that when used in combination offers patients improved vision outcomes over standard of care anti-VEGF-A monotherapy."

    Opthea is currently recruiting patients into two concurrent global, multi-center, randomized, double-masked, sham-controlled Phase 3 trials known as ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study). Both clinical studies will enroll ~990 treatment-naive patients each and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg ranibizumab (Lucentis®) or 2.0 mg aflibercept (Eylea®), compared to ranibizumab or aflibercept monotherapy, respectively.

    Additional information on Opthea's technology and clinical trials can be found at www.opthea.com and at ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636).

    Authorized for release to ASX by Megan Baldwin, CEO & Managing Director

    Company & Media Enquiries:Join our email database to receive program updates:
    U.S.A. & International:

    Sam Martin

    Argot Partners

    Tel: +1 212-600-1902





    Australia:

    Rudi Michelson

    Monsoon Communications

    Tel: +61 (0) 3 9620 3333

    Tel: +61 (0) 3 9826 0399



    www.opthea.com















    About Opthea

    Opthea ((ASX:OPT, NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea's lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone.

    Inherent risks of Investment in Biotechnology Companies

    There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.

    Forward-looking statements

    Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at risk statement, including, but not limited to, the continuation of patient recruitment for Opthea's pivotal Phase 3 clinical trials of OPT-302 in wet AMD. Such statements are based on Opthea's current plans, objectives, estimates, expectations and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus filed with the SEC on October 19, 2020. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement.



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  2. MELBOURNE, Australia, June 14, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT), 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.

    Mrs. Adams is an experienced finance executive who has directed financial operations at several ASX and dual ASX-Nasdaq listed companies. Mrs. Adams joins Opthea having previously served as Chief Financial Officer of Victor Smorgon Group with responsibilities for the financial reporting of multiple operating businesses of the Group. Prior to Victor Smorgon, Mrs. Adams was Director of…

    MELBOURNE, Australia, June 14, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT), 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.

    Mrs. Adams is an experienced finance executive who has directed financial operations at several ASX and dual ASX-Nasdaq listed companies. Mrs. Adams joins Opthea having previously served as Chief Financial Officer of Victor Smorgon Group with responsibilities for the financial reporting of multiple operating businesses of the Group. Prior to Victor Smorgon, Mrs. Adams was Director of Finance at Nexvet Biopharma where she was a key member of the Finance Team through the company's listing on the Nasdaq and subsequent acquisition by Zoetis, with multinational financial reporting responsibilities. Mrs. Adams' prior experience also includes several years as Financial Controller of Biota Holdings Limited and subsequently Biota Pharmaceuticals following the company's merger with Nabi Pharmaceuticals and Nasdaq listing, and Financial Controller of the multinational corporation Agva-Gevaert N.V.

    "We welcome Mrs. Adams to Opthea at an exciting time for the Company as we advance OPT-302 through pivotal Phase 3 clinical trials for wet age-related macular degeneration," commented Dr. Megan Baldwin, Chief Executive Officer and Managing Director of Opthea. "Mrs. Adams' extensive experience and sound understanding of corporate governance, processes, controls and financial reporting for dual ASX-Nasdaq listed companies will be an asset for Opthea, particularly as we build our presence in the U.S."

    Mrs. Adams holds a Bachelor of Business (Accounting) degree from Swinburne University and a Graduate Diploma of Applied Corporate Governance. Mrs. Adams graduated from the Australian Society of CPAs at Monash University as a Certified Practicing Accountant (CPA) in 1996.  

    Authorized for release to ASX by Megan Baldwin, CEO & Managing Director

    Company & Media Enquiries:Join our email database to receive program updates:
    U.S.A. & International:

    Sam Martin

    Argot Partners

    Tel: +1 212-600-1902









    Australia:

    Rudi Michelson

    Monsoon Communications

    Tel: +61 (0) 3 9620 3333

    Tel: +61 (0) 3 9826 0399



    www.opthea.com















    About Opthea

    Opthea ((ASX:OPT, NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea's lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone.

    Inherent risks of Investment in Biotechnology Companies

    There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.

    Forward-looking statements

    Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at risk statement, including, but not limited to, the continuation of patient recruitment for Opthea's pivotal Phase 3 clinical trials of OPT-302 in wet AMD. Such statements are based on Opthea's current plans, objectives, estimates, expectations and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus filed with the SEC on October 19, 2020. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement.



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    • Board expands strengths in clinical and commercialization strategy
    • OPT-302 pivotal Phase 3 trials for wet age-related macular degeneration (AMD) on track to reporting top-line data in 2023

    MELBOURNE, Australia, June 01, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT), 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. Dr. Haller is an internationally recognized ophthalmologist and vitreoretinal surgeon, currently serving as Ophthalmologist-in-Chief and William Tasman, MD Endowed…

    • Board expands strengths in clinical and commercialization strategy
    • OPT-302 pivotal Phase 3 trials for wet age-related macular degeneration (AMD) on track to reporting top-line data in 2023

    MELBOURNE, Australia, June 01, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT), 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. Dr. Haller is an internationally recognized ophthalmologist and vitreoretinal surgeon, currently serving as Ophthalmologist-in-Chief and William Tasman, MD Endowed Chair at Wills Eye Hospital in Philadelphia. Ms. Robertson is an accomplished life sciences commercial executive with an extensive track record for building, leading and launching several commercial organizations and products including successfully launching multiple ophthalmic products for pharmaceutical and biotechnology companies.

    "We are delighted to welcome Dr. Haller and Ms. Robertson to the Opthea Board of Directors. Both are recognized leaders in their respective fields. Their extensive expertise and advice will be instrumental as we progress OPT-302 through its pivotal Phase 3 clinical trials with top-line data on track for 2023 and, if successful, through commercialization," commented Dr. Jeremy Levin, Opthea's Chairman of the Board. "Building the Board has been an important milestone in our journey to potentially bring a unique medicine to address the unmet needs of those with retinal diseases."

    Dr. Julia Haller, Ophthalmologist-in-Chief and William Tasman, MD Endowed Chair at Wills Eye Hospital, serves as Professor and Chair of the Department of Ophthalmology at Sidney Kimmel Medical College at Thomas Jefferson University and is a recognized authority in therapies to treat and prevent blindness, having published over 350 scientific articles and book chapters. She is also on the Board of Directors of Bristol Myers Squibb and President of the John Hopkins Medical and Surgical Association. Dr. Haller previously served on the Board of Celgene Corporation (acquired by Bristol Myers Squibb). In addition to serving on numerous boards, Dr. Haller serves as chair of the American Ophthalmological Society's Council, vice chair of the College of Physicians of Philadelphia and chair of the Society of Heed Fellows. She is a member of the National Academy of Medicine, and president of the Women in Medicine Legacy Foundation.

    Dr. Haller received her Bachelor of Arts from Princeton University, graduating magna cum laude, and completed her medical training at Harvard Medical School. Her previous appointments include Professor of Ophthalmology, Johns Hopkins University School of Medicine, The Wilmer Eye Institute.

    Ms. Judith Robertson, most recently Chief Commercial Officer of Eleusis Ltd, was previously Chief Commercial Officer of Aerie Pharmaceuticals, where she oversaw the launch of Rhopressa®, the first product targeting a new mechanism of action for the treatment of glaucoma in 20 years, and the launch of the combination product Rocklatan®. Prior to Aerie, Ms. Robertson was Global Commercial Vice President Immunology and Ophthalmology at Johnson and Johnson, Janssen Pharmaceuticals, and Global Vice President Ophthalmology at Novartis (formerly Alcon). Her prior experience also includes several senior executive commercial roles at Novartis, Searle and Bristol Myers Squibb including President and General Manager of Bristol Myers Squibb Canada. In addition to Opthea, Ms. Robertson serves on the Board of Durect Corporation, a Nasdaq listed company developing therapies for acute organ injury and chronic liver diseases.

    Ms. Robertson holds a Bachelor of Arts (Honors) degree from Ryerson University in Canada and an MBA from Northwestern University, Kellogg School of Management in Chicago.

    About Opthea

    Opthea ((ASX:OPT, NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea's lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone.

    Inherent risks of Investment in Biotechnology Companies

    There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.

    Forward-looking statements

    Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at risk statement, including, but not limited to, the continuation of patient recruitment for Opthea's pivotal Phase 3 clinical trials of OPT-302 in wet AMD. Such statements are based on Opthea's current plans, objectives, estimates, expectations and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus filed with the SEC on October 19, 2020. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement.

    Authorized for release to ASX by Megan Baldwin, CEO & Managing Director

    Company & Media Enquiries:Join our email database to receive

    program updates:
    U.S.A. & International:

    Sam Martin

    Argot Partners

    Tel: +1 212-600-1902







    Australia:


    Rudi Michelson

    Monsoon Communications

    Tel: +61 (0) 3 9620 3333

    Tel: +61 (0) 3 9826 0399



    www.opthea.com















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  3. MELBOURNE, Australia, April 06, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT) advises that Mr Michael Tonroe has resigned as Company Secretary and Chief Financial Officer (CFO) of the Company, with effect 24 June 2021. Opthea has initiated a search for a permanent replacement with requisite expertise in financial reporting and company secretarial duties for a dual ASX and Nasdaq listed company.

    Mr Tonroe leaves Opthea at a time of corporate growth and emerging presence in the US to align with the recent listing on Nasdaq and initiation of the Company's global Phase 3 clinical development program for OPT-302 in wet age-related macular degeneration (wet AMD).

    Dr Megan Baldwin, CEO and Managing Director of Opthea, commented…

    MELBOURNE, Australia, April 06, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT) advises that Mr Michael Tonroe has resigned as Company Secretary and Chief Financial Officer (CFO) of the Company, with effect 24 June 2021. Opthea has initiated a search for a permanent replacement with requisite expertise in financial reporting and company secretarial duties for a dual ASX and Nasdaq listed company.

    Mr Tonroe leaves Opthea at a time of corporate growth and emerging presence in the US to align with the recent listing on Nasdaq and initiation of the Company's global Phase 3 clinical development program for OPT-302 in wet age-related macular degeneration (wet AMD).

    Dr Megan Baldwin, CEO and Managing Director of Opthea, commented, "Mr Tonroe joined Opthea in 2014 and since that time has become an integral and valued member of the team, navigating our transition to an ophthalmology focused company, through successful clinical trials, financings and more recently, our US listing on the Nasdaq. As a consistent and supportive colleague, Mike has been a pleasure to work with. On behalf of the Board, we extend our appreciation to Mr Tonroe for his contributions to the Company during his tenure and sincerely wish him well for his future career opportunities."

    Mr Tonroe will remain Company Secretary and CFO until the effective date of his resignation and assist in the transition of duties to an interim or permanent replacement in June 2021.  

    Company & Media Enquiries:Join our email database to receive program updates:


    Megan Baldwin, PhD                

    CEO & Managing Director

    Opthea Limited

    Tel: +61 (0) 447 788 674





    Australia:

    Rudi Michelson

    Monsoon Communications

    Tel: +61 (0) 3 9620 3333





    Tel: +61 (0) 3 9826 0399



    www.opthea.com







    U.S.A. & International:

    Jason Wong

    Blueprint Life Science Group

    Tel: +1 415 375 3340, Ext 4

    About Opthea

    Opthea ((ASX:OPT, NASDAQ:OPT) is a biopharmaceutical company developing a novel therapy to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea's lead product candidate OPT-302 is being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone.

    Inherent risks of Investment in Biotechnology Companies

    There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.

    Forward-looking statements

    Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at risk statement, including, but not limited to, the continuation of patient recruitment for Opthea's pivotal Phase 3 clinical trials of OPT-302 in wet AMD. Such statements are based on Opthea's current plans, objectives, estimates, expectations and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus filed with the SEC on October 19, 2020. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement.



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  4. MELBOURNE, Australia, March 31, 2021 (GLOBE NEWSWIRE) -- 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 that it has received an initial Pediatric Study Plan (iPSP) waiver from the US Food and Drug Administration (FDA) for OPT-302, the Company's lead product candidate currently in Phase 3 clinical development for the treatment of neovascular (wet) age-related macular degeneration.

    As part of the regulatory review process, a bio-pharmaceutical company that is planning to submit a marketing application of a new medicine with the FDA is required to provide an iPSP detailing the Company's proposed strategy for…

    MELBOURNE, Australia, March 31, 2021 (GLOBE NEWSWIRE) -- 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 that it has received an initial Pediatric Study Plan (iPSP) waiver from the US Food and Drug Administration (FDA) for OPT-302, the Company's lead product candidate currently in Phase 3 clinical development for the treatment of neovascular (wet) age-related macular degeneration.

    As part of the regulatory review process, a bio-pharmaceutical company that is planning to submit a marketing application of a new medicine with the FDA is required to provide an iPSP detailing the Company's proposed strategy for investigation of the new medicinal product in the pediatric population. In some instances, a waiver from developing an iPSP for certain conditions may be agreed to by the Agency.

    Opthea received from the FDA an official, agreed iPSP waiver for OPT-302 across all subsets of the pediatric population (full pediatric age group from birth to < 17 years) for the treatment of wet AMD in combination with intravitreal anti-VEGF-A therapy. The receipt of the agreed iPSP waiver means the Company will not have to conduct an additional study in the pediatric population.

    Dr Megan Baldwin, CEO of Opthea commented: "The agreed iPSP waiver is an important regulatory milestone in the US that is required to be completed before Opthea is able to submit a marketing application for OPT-302 to the FDA. Opthea will continue the process to further fulfilling regulatory requirements by focusing on our pivotal Phase 3 clinical trials in adult patients that are designed to support potential marketing approval of OPT-302 for the treatment of wet AMD."

    Additional information on Opthea's technology and clinical trials can be found at www.opthea.com.

    Company & Media Enquiries:



    Join our email database to receive program updates:
    Megan Baldwin, PhD                

    CEO & Managing Director

    Opthea Limited

    Tel: +61 (0) 447 788 674





    Australia:

    Rudi Michelson

    Monsoon Communications

    Tel: +61 (0) 3 9620 3333

    Tel: +61 (0) 3 9826 0399



    www.opthea.com





    U.S.A. & International:

    Jason Wong

    Blueprint Life Science Group

    Tel: +1 415 375 3340, Ext 4

    About Opthea

    Opthea ((ASX:OPT, NASDAQ:OPT) is a biopharmaceutical company developing a novel therapy to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea's lead product candidate OPT-302 is being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone.

    Inherent risks of Investment in Biotechnology Companies

    There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.

    Forward-looking statements

    Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at risk statement, including, but not limited to, the continuation of patient recruitment for Opthea's pivotal Phase 3 clinical trials of OPT-302 in wet AMD. Such statements are based on Opthea's current plans, objectives, estimates, expectations and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the final prospectus filed with the SEC on October 19, 2020. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement.

     



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