OPT Opthea Limited
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
OPT-302 with Ranibizumab - ShORe
Wet age-related macular degeneration (AMD)
|
Phase 3
Phase 3
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
|
OPT-302 with Aflibercept - COAST
Age-related macular degeneration (AMD)
|
Phase 3
Phase 3
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
OPT-302
Diabetic macular edema
|
Phase 1/2
Phase 1/2
|
Phase 2a trial completed.
|
Latest News
-
View Full Article Hide Full Article
MELBOURNE, Australia, Oct. 19, 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, today announced that the first clinical trial sites in the Asia-Pacific region are now open for patient enrollment into the OPT-302 Phase 3 pivotal clinical program for the treatment of wet (neovascular) age-related macular degeneration (AMD). The clinical trial sites, located in Australia, further build upon the progress of other international regions including the U.S., Canada and Europe that are also actively recruiting patients.
"We are delighted to open enrollment in the Asia-Pacific region. This is a significant milestone for the OPT-302 development program and enables eligible patients to participate in the ShORe and COAST Phase 3 trials which are designed based on strong scientific rationale, prior positive clinical efficacy results and extensive safety data in the wet AMD target population. Over the following weeks we anticipate opening sites in additional countries in the Asia Pacific region including South Korea and the Philippines," said Dr Megan Baldwin, CEO and Managing Director of Opthea.
The ShORe and COAST studies are both double‑masked, sham‑controlled Phase 3 registrational trials to evaluate efficacy and safety of intravitreal 2.0 mg OPT‑302 in combination with either 0.5 mg ranibizumab (Lucentis®), or 2.0 mg aflibercept (Eylea®) respectively. The primary endpoint of the studies is the mean change in best corrected visual acuity from baseline to week 52 for OPT‑302 combination therapy compared to standard of care anti‑VEGF‑A monotherapy. The read-out of the top-line results through 52 weeks is anticipated in the second half of 2023, and following completion of this primary efficacy phase, the Company plans to file Biologics License and Marketing Authorization Applications with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) respectively.
Recently, the FDA granted Fast Track status for OPT-302, in combination with anti-VEGF-A therapy for the treatment of patients with wet AMD and this regulatory designation offers 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.
Additional information on Opthea's technology and the Phase 3 pivotal clinical trials can be found at www.opthea.com and at ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636).
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
opthea@argotpartners.com
Australia:
Rudi Michelson
Monsoon Communications
Tel: +61 (0) 3 9620 3333
Tel: +61 (0) 3 9826 0399
info@opthea.com
www.opthea.com
-
View Full Article Hide Full Article
MELBOURNE, Australia, Oct. 04, 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, today announced that enrollment for its Phase 3 pivotal clinical program of OPT-302 for the treatment of wet (neovascular) age-related macular degeneration (AMD) is now open in Europe. The two concurrent global Phase 3 registrational clinical trials, ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study) will be conducted in up to 20 countries across Europe.
The ShORe and COAST registrational studies are expected to each enroll approximately 990 treatment naïve patients and are evaluating OPT-302 combination therapy as a potential treatment for wet AMD. Enrollment has been ongoing in the U.S. and Canada and is being expanded into Europe and the rest of the world.
"We are excited to expand the ShORe and COAST trials outside North America to European investigative sites which is an important step in our continued commitment to improve the lives of patients around the world suffering from retinal diseases," said Dr Megan Baldwin, CEO and Managing Director of Opthea. "Europe represents another key market, given the large population of patients that reside there, and establishing a presence will help support the development of OPT-302, as well as future regulatory submissions and commercialization plans."
Opthea is conducting ShORe and COAST as two concurrent global, multi‑center, double‑masked, sham‑controlled Phase 3 trials to assess the efficacy and safety of intravitreal 2.0 mg OPT‑302 in combination with either 0.5 mg ranibizumab (Lucentis®), or 2.0 mg aflibercept (Eylea®) respectively. The primary endpoint of both 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. The top-line 52-week data from the ShORe and COAST Phase 3 studies is anticipated in the second half of 2023. Opthea intends to submit Biologics License and Marketing Authorisation Applications with the U.S Food and Drug Administration (FDA) and European Medicines Agency (EMA), respectively, following completion of the 12-month primary efficacy phase of the trials.
The FDA recently awarded OPT-302 Fast Track designation, which helps to speed clinical development, U.S. regulatory review, and market entry upon approval of treatments with a potential to address serious conditions. In addition, regulatory guidance received from the FDA and EMA, including alignment on the pivotal study designs, has provided Opthea with a pathway to advance OPT‑302 through Phase 3 registrational trials for the treatment of wet AMD in support of future filings for global marketing approval and commercial launches in the U.S. and Europe.
Additional information on Opthea's technology and the Phase 3 pivotal clinical trials can be found at www.opthea.com and at www.ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636).
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
opthea@argotpartners.com
Australia:
Rudi Michelson
Monsoon Communications
Tel: +61 (0) 3 9620 3333Tel: +61 (0) 3 9826 0399
info@opthea.com
www.opthea.com
-
View Full Article Hide Full Article
MELBOURNE, Australia, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, announced today that Dr Megan Baldwin, the Company's Chief Executive Officer, will participate in the following investor conferences in September:
Citi's 16th Annual BioPharma Virtual Conference
Date: Thursday, September 9, 2021 8:50 am ET (11:50 pm AEST)
Panel: Eyes on the Prize – Next Generation Retinal TherapeuticsH.C. Wainwright Annual Healthcare Conference
Date: Monday, September 13, 2021 7:00 am ET (9:00 pm AEST)Oppenheimer Healthcare Fall Summit
Date: Monday, September 20, 2021 4:35 pm ET (Tuesday, September 21, 2021, 7:35 am AEST)
The presentations may be accessed on the Investors page of the Opthea website at https://www.opthea.com/presentations/.About Opthea Limited
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.
Authorized for release to ASX by Megan Baldwin, CEO & Managing Director
Company & Media Enquiries:
U.S.A. & International: Australia: Sam Martin Rudi Michelson Argot Partners Monsoon Communications Tel: +1 212-600-1902 Tel: +61 (0) 3 9620 3333 opthea@argotpartners.com Join our email database to receive program updates:
Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web: www.opthea.com
-
View Full Article Hide Full Article
Treated First Patient in Phase 3 Pivotal Trials of OPT-302 in Wet Age-Related Macular Degeneration (AMD)
OPT-302 Granted FDA Fast Track Designation for Wet AMD
Received FDA Waiver for Pediatric Study Plan for OPT-302 in Wet AMD
ShORe and COAST Phase 3 Clinical Trials Opened Recruitment to Patients in U.S. & Canada
MELBOURNE, Australia, Aug. 30, 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, today reported financial results for the year ended June 30, 2021 and provided an overview of recent progress and accomplishments.
"Despite the continued impact of COVID-19 around the world, our team has continued to make steady progress advancing our lead program, OPT-302, and strengthening the Company for continued global expansion," said Dr. Megan Baldwin, CEO and Managing Director of Opthea. "Dosing the first patients in our OPT-302 Phase 3 pivotal clinical program in wet AMD marked a very important achievement for Opthea in accelerating the development of this novel VEGF-C/D inhibitor therapy towards market registration. FDA Fast Track designation for OPT-302 also provides regulatory support in expediting the Phase 3 development program to advance our promising treatment to patients sooner. These encouraging developments bring us closer to accomplishing our mission to improve the lives of patients suffering from retinal diseases."
Corporate Highlights
- In March 2021, Opthea announced that the first patient had been treated in its Phase 3 pivotal program for OPT-302 for wet AMD. Opthea is conducting two concurrent global, multi-center, randomized, double-masked, sham-controlled Phase 3 trials known as ShORe and COAST.
- In March 2021, Opthea announced that it received an initial Pediatric Study Plan (iPSP) waiver from the U.S. Food and Drug Administration (FDA) for OPT-302. With this waiver, Opthea will not have to conduct an additional study of OPT-302 in the pediatric population for use of OPT-302 in this U.S. population.
- In July 2021, the FDA granted Fast Track designation for OPT-302 in combination with anti-VEGF- A therapy for the treatment of patients with wet AMD. Fast Track designation offers benefits to expedite the OPT-302 Phase 3 clinical program and subsequent potential approval process.
- In August 2021, Opthea announced the expansion of the Phase 3 ShORe and COAST wet AMD trials of OPT-302 into Canada. With the Phase 3 pivotal clinical program ongoing in the U.S., the expansion into Canada represents a new and important geographical region.
- Over the past year, Opthea strengthened its Board of Directors with the appointment of Dr. Jeremy Levin as Chairman and Dr. Julia Haller and Ms. Judith Robertson as non-executive directors.
Fiscal Year 2021 Financial Results
As of June 30, 2021, Opthea had cash, cash equivalents and short-term investments of US$118.2 million.
Research and development expenses for the fiscal year ended June 30, 2021 were US$25.9 million, compared to US$12.1 million for the year ended June 30, 2020. The increase of US$13.8 million reflects costs associated with the Phase 2b and Phase1b/2a clinical trials of OPT‑302 for wet AMD and DME and the initiation of the Phase 3 clinical trials. Administrative expenses for the fiscal year ended June 30, 2021 were US$13.4 million, compared to US$4.7 million for the same prior year period.
Opthea reported a net loss, including non-cash charges, of US$45.3 million or $0.14 per share for the year ended June 30, 2021. This compares to a net loss, including non-cash charges, of US$11.1 million or $0.04 per share for the comparable period in 2020.
A copy of Opthea's financial results and Annual Report for the financial year ending June 30, 2021 is available on the Company's website www.opthea.com/annual-reports/.
About Opthea Limited
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 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 Opthea's filings with the ASX and the U.S. Securities and Exchange Commission, including 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:
Australia: U.S.A. & International: Rudi Michelson, Monsoon Communications
Tel: +61 (0) 3 9620 3333Sam Martin, Argot Partners
Tel: +1 212-600-1902; opthea@argotpartners.comJoin our email database to receive program updates:
Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web: www.opthea.com
- In March 2021, Opthea announced that the first patient had been treated in its Phase 3 pivotal program for OPT-302 for wet AMD. Opthea is conducting two concurrent global, multi-center, randomized, double-masked, sham-controlled Phase 3 trials known as ShORe and COAST.
-
View Full Article Hide Full Article
MELBOURNE, Australia, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, announced today that Dr Megan Baldwin, the Company's Chief Executive Officer, will give a corporate presentation at the H.C. Wainwright Ophthalmology Virtual Conference being held August 17, 2021.
The presentation will be made available on-demand beginning Tuesday, August 17, 2021 at 7:00am ET (Tuesday, August 17, 2021 at 9:00pm AEST) and may be accessed on the Investors page of the Opthea website at https://www.opthea.com/presentations/.
About Opthea Limited
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.
Authorized for release to ASX by Megan Baldwin, CEO & Managing Director
Company & Media Enquiries:
U.S.A. & International: Australia: Sam Martin Rudi Michelson Argot Partners Monsoon Communications Tel: +1 212-600-1902 Tel: +61 (0) 3 9620 3333 opthea@argotpartners.com Join our email database to receive program updates:
Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web: www.opthea.com
