OPT Opthea Limited

8.25
-0.39  -5%
Previous Close 8.64
Open 7.95
52 Week Low 7.95
52 Week High 13.9999
Market Cap $348,216,173
Shares 42,208,021
Float 42,208,021
Enterprise Value $221,103,401
Volume 5,053
Av. Daily Volume 7,326
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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, 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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  2. 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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  3. MELBOURNE, Australia, March 15, 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, 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 (neovascular) age-related macular degeneration (AMD). The first patient was enrolled by Dr Allen Hu, MD, Cumberland Valley Retina Consultants, Hagerstown, Maryland, USA.

    "Dosing the first patient in our OPT-302 Phase 3 pivotal clinical program in wet AMD marks a very important achievement for Opthea in…

    MELBOURNE, Australia, March 15, 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, 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 (neovascular) age-related macular degeneration (AMD). The first patient was enrolled by Dr Allen Hu, MD, Cumberland Valley Retina Consultants, Hagerstown, Maryland, USA.

    "Dosing the first patient in our OPT-302 Phase 3 pivotal clinical program in wet AMD marks a very important achievement for Opthea in accelerating the development of this novel VEGF-C/D inhibitor therapy towards market registration," commented Dr Megan Baldwin, Chief Executive Officer of Opthea. "We are now looking forward to quickly ramping up enrolment to meet the interest from participating clinical sites and retinal specialists. OPT-302, which has shown promising efficacy and favorable safety profiles in trials to date, is an important new treatment option which may offer patients improved outcomes when administered in combination with VEGF-A inhibitors."

    Opthea is conducting 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.

    The primary endpoint of the ShORe and COAST studies is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT-302 combination therapy compared to anti-VEGF-A monotherapy. Each patient will also continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period. A number of secondary endpoints will also be evaluated, including other key measures of visual function, as well as anatomical changes in the wet AMD lesions assessed by optical coherence tomography (OCT) and fluorescein angiography imaging. In addition, extended durability of the OPT-302 treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with OPT-302 administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor.

    The initiation of the Phase 3 pivotal clinical program follows the reporting of positive outcomes from the Phase 2b clinical trial of OPT-302 in 366 patients with wet AMD. The results from the Phase 2b study demonstrated a statistically significant superior mean gain in visual acuity in patients treated with OPT-302 combination therapy compared to ranibizumab monotherapy at week 24. The ShORe and COAST Phase 3 trials build upon and maintain key features of the successful Phase 2b wet AMD clinical trial, whilst also evaluating the administration of OPT-302 in combination with ranibizumab and aflibercept over a longer treatment period and in a greater number of patients.

    Opthea anticipates reporting top-line data in 2023, with the Company intending to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA respectively following completion of the 12-month primary efficacy phase of the trials.

    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). Summaries of the ShORe and COAST Phase 3 Clinical Trials are included below.

    CLINICAL TRIAL SUMMARIES

    Protocol NumberOPT-302-1004
    Study TitleA Phase 3 study of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with neovascular age-related macular degeneration (AMD)
    Study NameShORe – Study of OPT-302 in combination with Ranibizumab in neovascular AMD
    SponsorOpthea Limited
    IndicationNeovascular (wet) age-related macular degeneration (AMD)
    Study Phase3
    Primary ObjectiveTo determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular AMD
    Primary EndpointMean change from Baseline to Week 52 in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) letters
    Secondary Endpoints
    • Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52
    • Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52
    • Proportion of participants with absence of both SRF and IR cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52
    • Change in CNV area by fluorescein angiography (FA) from Baseline to Week 52
    • Change in CST by SD-OCT from Baseline to Week 52
    • Change in the NEI VFQ-25 composite score from Baseline to Week 52
    • Incidence of ocular and non-ocular treatment-emergent adverse events
    • Proportion of participants losing 15 or more ETDRS BCVA letters from Baseline to Week 52
    • Participant incidence of ADA formation
    • OPT-302 pharmacokinetic parameters
    Study DesignPhase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked, superiority study
    Investigational Product2.0 mg OPT-302 intravitreal injection
    Co-administered anti-VEGF-A therapy0.5 mg ranibizumab intravitreal injection
    ControlSham intravitreal injection
    Study Arms Three study arms, randomised in a 1:1:1 ratio:

    • Standard Dosing: 2.0 mg OPT-302 (50 μl) intravitreal injection with 0.5 mg ranibizumab (50 μl) intravitreal injection, both administered 4-weekly (q4w)
    • Extended Dosing: 2.0 mg OPT-302 (50 μl) intravitreal injection (3 doses at 4-weekly intervals, and then 8-weekly [q4w x 3 then q8w]) with sham injection at visits when OPT-302 is not administered, with 0.5 mg ranibizumab (50 μl) intravitreal injection 4-weekly (q4w)
    • Control Sham intravitreal injection with 0.5 mg ranibizumab (50 μl) intravitreal injection, both administered 4-weekly (q4w)
    Key Eligibility Criteria
    • Participants ≥ 50 years of either gender, with active CNV secondary to AMD confirmed by fluorescein angiography (FA), who are treatment naïve
    • An ETDRS BCVA score between 60 and 25 (inclusive) letters



    Protocol NumberOPT-302-1005
    Study TitleA Phase 3 study of intravitreal OPT-302 in combination with aflibercept, compared with aflibercept alone, in participants with neovascular age-related macular degeneration (AMD)
    Study NameCOAST – Combination OPT-302 with Aflibercept STudy in neovascular AMD
    SponsorOpthea Limited
    IndicationNeovascular (wet) age-related macular degeneration (AMD)
    Study Phase3
    Primary ObjectiveTo determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD
    Primary EndpointMean change from Baseline to Week 52 in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) letters
    Secondary Endpoints
    • Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52
    • Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52
    • Proportion of participants with absence of both SRF and IR cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52
    • Change in CNV area by fluorescein angiography (FA) from Baseline to Week 52
    • Change in CST by SD-OCT from Baseline to Week 52
    • Change in the NEI VFQ-25 composite score from Baseline to Week 52
    • Incidence of ocular and non-ocular treatment-emergent adverse events
    • Proportion of participants losing 15 or more ETDRS BCVA letters from Baseline to Week 52
    • Participant incidence of ADA formation
    • OPT-302 pharmacokinetic parameters
    Study DesignPhase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked, superiority study
    Investigational Product2.0 mg OPT-302 intravitreal injection
    Co-administered anti-VEGF-A therapy2.0 mg aflibercept intravitreal injection
    ControlSham intravitreal injection
    Study ArmsThree study arms, randomised in a 1:1:1 ratio:

    • Standard Dosing: 2.0 mg OPT-302 (50 μl) intravitreal injection at 4-weekly intervals (q4w), with 2.0 mg aflibercept (50 μl) intravitreal injection (3 doses at 4-weekly intervals, and then 8-weekly [q4w x 3 then q8w]).
    • Extended Dosing: 2.0 mg OPT-302 (50 μl) intravitreal injection (q4w x 3 then q8w) with sham injection at visits when OPT-302 is not administered, with 2.0 mg aflibercept (50 μl) intravitreal injection (q4w x 3 then q8w).
    • Control Sham intravitreal injection 4-weekly, with 2.0 mg aflibercept (50 μl) intravitreal injection (q4w x 3 then q8w)
    Key Eligibility Criteria
    • Participants ≥ 50 years of either gender, with active CNV secondary to AMD confirmed by fluorescein angiography (FA), who are treatment naïve
    • An ETDRS BCVA score between 60 and 25 (inclusive) letters

    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.

    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



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  4. MELBOURNE, Australia, March 10, 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 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 (Wednesday, March 17, 2021 at 6:50am AEDT).

    A live webcast of the presentation will be available on the Investors page of the Opthea website at https://www.opthea.com/presentations/.

    About Opthea

    Opthea ((ASX:OPT, NASDAQ:OPT) is a biopharmaceutical company developing a novel therapy to address the unmet need in the treatment…

    MELBOURNE, Australia, March 10, 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 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 (Wednesday, March 17, 2021 at 6:50am AEDT).

    A live webcast of the presentation will be available on the Investors page of the Opthea website at https://www.opthea.com/presentations/.

    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 initiation of patient recruitment for Opthea's planned 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.

    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



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    • 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

    • Internationally recognized retinal disease specialists, Prof Timothy Jackson and Dr Charles Wykoff, named Chief investigators for the ShORe and COAST trials, respectively. In addition, Dr Jason Slakter, founder of the Digital Angiography Reading Center (DARC) in New York, will contribute expertise in ocular imaging.

    • Opthea confirms planned initiation of Pivotal Phase 3 trials remains on-track for CY 1Q'21

    MELBOURNE, Australia, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Opthea Limited ((ASX:OPT, NASDAQ:OPT

    • 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



    • Internationally recognized retinal disease specialists, Prof Timothy Jackson and Dr Charles Wykoff, named Chief investigators for the ShORe and COAST trials, respectively. In addition, Dr Jason Slakter, founder of the Digital Angiography Reading Center (DARC) in New York, will contribute expertise in ocular imaging.



    • Opthea confirms planned initiation of Pivotal Phase 3 trials remains on-track for CY 1Q'21

    MELBOURNE, Australia, Feb. 24, 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 finalized the protocol study designs and key start-up activities in readiness for the initiation of the Phase 3 ShORe and COAST pivotal clinical trials of OPT-302 in wet age-related macular degeneration (AMD).

    Finalization of the Phase 3 trial protocols follows productive consultations with the FDA, EMA and world-renowned Key Opinion Leaders (KOLs) in wet AMD. The trial protocols have also been submitted to relevant regulatory agencies, institutional review boards and human research ethics committees.

    Two global experts in the treatment of retinal diseases, Prof Timothy Jackson and Dr Charles Wykoff, will be the Chief investigators for the ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study) trials, respectively.

    Professor Jackson, PhD, FRCOphth, is a consultant ophthalmic surgeon at King's College, London, and was also the Chief Investigator on the Opthea Phase 2b wet AMD clinical trial. Dr Wykoff, MD PhD, is the Director of Research, Retina Consultants of Texas and Deputy Chair for Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, Houston Texas. Another eminent retina specialist, Dr Jason Slakter, founder and Director of the Digital Angiography Reading Center (DARC) in New York, and Clinical Professor of Ophthalmology at NYU School of Medicine, will also provide expertise as a leading authority on ocular imaging for the Phase 3 clinical program.

    "The collaborative nature of our study protocol discussions with our KOLs, the FDA and EMA has been very pleasing and the constructive input received ensures that the design of the OPT-302 Phase 3 program has the potential to generate compelling and persuasive clinical data capable of satisfying regulatory requirements," said Dr Megan Baldwin, Chief Executive Officer of Opthea. "With the achievement of other key start-up milestones, including successful scale-up of manufacturing and fill-finish of OPT-302 drug product for use in the trials, we now excitedly look forward to initiating the pivotal Phase 3 studies that are designed to support potential marketing approval of OPT-302 for the treatment of wet AMD."

    The global, multi-centre, double-masked, sham-controlled, pivotal Phase 3 clinical trials will each enrol ~990 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg ranibizumab (Lucentis®) (ShORe trial) or 2.0 mg aflibercept (Eylea®) (COAST trial), compared to ranibizumab or aflibercept monotherapy, respectively. In addition, extended durability of the OPT-302 treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with OPT-302 administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor. If effective in these Phase 3 studies, OPT-302 could be adopted for administration with either Eylea or Lucentis which had combined sales for retinal diseases of USD$11.9 billion in 2019.

    The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT-302 combination therapy compared to anti-VEGF-A monotherapy. Each patient will continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period.

    Opthea remains on track to initiate the trials in the first quarter of calendar year (CY) 2021 and to report top-line data in the second half CY 2023. If the results at the completion of the primary efficacy phase at week 52 of the Phase 3 clinical trials are favourable, the Company intends to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA respectively for marketing approval for OPT-302 for the treatment of wet AMD in the United States, European Union and other global territories.

    Additional information on Opthea's technology and clinical trials can be found appended to this announcement and 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 the ShORe Pivotal Phase 3 Clinical Trial

    In the Study of OPT-302 in combination with Ranibizumab, or ShORe, Phase 3 trial, ~990 treatment-naive

    patients with wet AMD will be randomized 1:1:1 to one of three treatment groups. Patients randomized to the standard OPT-302 dosing arm will receive standard of care 0.5 mg ranibizumab every four weeks in combination with 2.0 mg OPT-302 on a every 4-week dosing regimen. In the extended OPT-302 dosing arm, 0.5 mg ranibizumab will be administered every four weeks to week 52, in combination with 2.0 mg OPT-302 administered every four weeks for three loading doses, followed by OPT-302 dosing on an every 8-week dosing regimen to week 52, with a sham injection given at visits where OPT-302 is not administered. Patients randomized to the control arm will receive 0.5 mg ranibizumab in combination with sham intravitreal injections administered every four weeks to week 52.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a9349638-ba1f-4094-a755-8093a4bbdbde

    About the COAST Pivotal Phase 3 Clinical Trial

    In the Combination OPT-302 with Aflibercept STudy, or COAST, Phase 3 trial, ~990 treatment-naive wet AMD patients will be randomized 1:1:1 to one of three treatment groups. Patients randomized to the standard OPT-302 dosing arm will receive 2.0 mg aflibercept administered every four weeks for three loading doses, followed by aflibercept dosing every eight weeks to week 52, in combination with 2.0 mg OPT-302 administered every four weeks to week 52. In the extended OPT-302 dosing arm, 2.0 mg aflibercept in combination with 2.0 mg OPT-302 will be administered every four weeks for three loading doses, followed by dosing every eight weeks to week 52, with a sham injection given at visits where OPT-302 and aflibercept are not administered. Patients randomized to the control arm, will receive 2.0 mg aflibercept administered every four weeks for three loading doses, followed by dosing every eight weeks to week 52, in combination with sham intravitreal injections administered every four weeks to week 52.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/de959ea2-dff3-4f9b-9754-ca756a624883

    The primary and secondary efficacy outcomes for both Phase 3 studies will be determined at the end of the efficacy phase at week 52. Each patient will then continue to be treated for an additional year through week 100 to further evaluate safety and tolerability over a total two-year period.

    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 initiation of patient recruitment for Opthea's planned 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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