Opthea Stock Price, News & Analysis

Opthea Limited (ASX: OPT) is a clinical-stage biopharmaceutical company focused on developing novel therapies for vision‑threatening retinal diseases. According to the company’s public disclosures, Opthea is developing drug candidates for conditions such as wet age‑related macular degeneration (wet AMD) and diabetic macular edema (DME), which are described as leading causes of vision loss worldwide. Opthea’s shares trade on the Australian Securities Exchange, and the company has also listed American Depositary Shares on The Nasdaq Global Select Market, although it has notified Nasdaq of its intention to voluntarily delist those ADSs.

Business focus and lead product candidate

Opthea describes itself as a biopharmaceutical company developing therapies to address unmet needs in highly prevalent and progressive retinal diseases. Its lead product candidate is sozinibercept, characterized in company materials as a first‑in‑class VEGF‑C/D ‘trap’ inhibitor. Sozinibercept is being evaluated in combination with standard‑of‑care anti‑VEGF‑A therapies in patients with wet AMD and has also been studied in DME. The company reports that VEGF‑C and VEGF‑D are known to stimulate retinal angiogenesis and vascular leakage, and that inhibiting these pathways may help prevent abnormal blood vessel growth and leakage that contribute to retinal disease.

Opthea’s clinical development program has included a randomized, controlled Phase 2b trial in treatment‑naïve wet AMD patients, in which sozinibercept was administered in combination with ranibizumab. The company states that this study met its pre‑specified primary efficacy endpoint, showing a statistically superior gain in visual acuity at 24 weeks compared to ranibizumab alone, with additional positive secondary anatomical outcomes. Opthea has also reported Phase 1b data in DME patients previously treated with anti‑VEGF‑A monotherapy, describing sozinibercept combination therapy as well tolerated and associated with visual and anatomical improvements.

Phase 3 development in wet AMD

For wet AMD, Opthea has outlined a pivotal Phase 3 program consisting of two fully enrolled, multicenter, double‑masked, randomized clinical trials: COAST (Combination OPT‑302 with Aflibercept Study) and ShORe (Study of OPT‑302 in combination with Ranibizumab). In its announcements, the company explains that these trials are designed to assess the safety and superiority of sozinibercept combination therapy versus standard‑of‑care anti‑VEGF‑A monotherapy. The primary endpoint for both trials is the mean change in best corrected visual acuity (BCVA) from baseline to week 52.

Opthea has reported completion of the final week 52 patient visit in the COAST trial and has discussed plans for extended follow‑up to evaluate safety and tolerability over a two‑year period. The company has also disclosed that sozinibercept has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of wet AMD.

DME program and scientific publications

Beyond wet AMD, Opthea is investigating sozinibercept in diabetic macular edema. The company has announced publication of a Phase 1b dose‑escalation study in DME in the journal Translational Vision Science & Technology, describing outcomes in patients with persistent DME despite prior anti‑VEGF‑A monotherapy. Opthea reports that sozinibercept in combination with aflibercept was well tolerated, with a dose‑response relationship in visual acuity gains and meaningful reductions in central subfield thickness.

Opthea has also highlighted peer‑reviewed publications and conference presentations related to its wet AMD program. These include Phase 2b subgroup analyses examining angiographic lesion characteristics predictive of response to sozinibercept combination therapy, and presentations at meetings such as the Macula Society Annual Meeting. The company points to these data as informing the design of its Phase 3 clinical program.

Manufacturing and regulatory preparation

In addition to clinical development, Opthea has reported progress in chemistry, manufacturing and controls (CMC) activities for sozinibercept. The company has announced completion of both drug substance and drug product Process Performance Qualification (PPQ) campaigns, including the successful production of three consecutive commercial‑scale drug product batches. Opthea states that these steps are intended to validate its manufacturing process in preparation for a potential biologics license application (BLA) filing for sozinibercept in wet AMD.

Capital markets and listing status

Opthea’s securities are listed on the ASX, and the company has also had American Depositary Shares listed on The Nasdaq Global Select Market. In a Form 6‑K dated October 30, 2025, Opthea reported issuing a press release announcing its intention to voluntarily delist its ADSs from Nasdaq. A subsequent Form 25, filed on November 10, 2025, notifies the removal of the ADSs from listing and registration under Section 12(b) of the Securities Exchange Act of 1934, stating that the issuer has complied with the rules of the exchange and the requirements governing voluntary withdrawal.

Opthea has also discussed its financial position and funding in public updates, including references to cash and cash equivalents and capital raising activities to support its Phase 3 program and related manufacturing work. The company notes that investment in biotechnology and drug development carries inherent risks, including clinical, regulatory, intellectual property, and funding uncertainties.

Corporate updates and strategic review

In a corporate update, Opthea described the impact of not meeting primary endpoints in its COAST and ShORe Phase 3 clinical trials for sozinibercept in wet AMD and the subsequent decision, together with its development funding agreement (DFA) investors, to discontinue development of sozinibercept in that indication. The company outlined a settlement of the DFA that included a one‑time cash payment to the DFA investors and the issuance of new equity, and stated that these arrangements were expected to result in Opthea remaining solvent with a specified level of cash and cash equivalents.

Following the settlement, Opthea reported significant operational changes, including workforce reductions, changes to its board of directors, and the planned departure of certain senior executives. The company indicated that it would undertake a strategic review over a defined period, considering options such as targeted internal development, strategic partnerships or business development and licensing opportunities, and potential return of capital to shareholders, where appropriate.

Risk considerations

Opthea’s announcements emphasize that development of pharmaceutical products is subject to substantial risk. The company highlights factors such as the possibility that drug candidates may not demonstrate safety or efficacy in clinical trials, uncertainties around patent protection and regulatory approvals, dependence on external partners and service providers, and the need to secure ongoing funding. Opthea characterizes investment in companies specializing in drug development as highly speculative and recommends that potential investors seek professional investment advice.

FAQs about Opthea Limited (OPT)

• What does Opthea Limited do?
  Opthea Limited is a clinical‑stage biopharmaceutical company developing drug candidates for vision‑threatening retinal diseases. The company’s disclosures describe a focus on wet age‑related macular degeneration and diabetic macular edema.
• What is Opthea’s lead product candidate?
  Opthea’s lead product candidate is sozinibercept, described as a first‑in‑class VEGF‑C/D ‘trap’ inhibitor. It has been evaluated in combination with standard‑of‑care anti‑VEGF‑A therapies in clinical trials for wet AMD and DME.
• How is sozinibercept being studied in wet AMD?
  The company has conducted a Phase 2b randomized, controlled trial in treatment‑naïve wet AMD patients and a pivotal Phase 3 program with two trials, COAST and ShORe, designed to compare sozinibercept combination therapy against anti‑VEGF‑A monotherapy using visual acuity endpoints.
• What clinical data has Opthea reported so far?
  Opthea reports that its Phase 2b wet AMD trial met its primary endpoint of superior visual acuity gain at 24 weeks for sozinibercept plus ranibizumab versus ranibizumab alone, with positive secondary anatomical outcomes. In DME, a Phase 1b study showed that sozinibercept in combination with aflibercept was well tolerated and associated with visual and anatomical improvements.
• Which diseases does Opthea target?
  Company materials identify wet age‑related macular degeneration and diabetic macular edema as key target indications. Both are described as highly prevalent retinal diseases and leading causes of vision loss.
• What is known about Opthea’s manufacturing capabilities?
  Opthea has announced completion of drug substance and drug product Process Performance Qualification campaigns for sozinibercept, including successful production of multiple commercial‑scale batches to support potential regulatory filings.
• On which exchanges has Opthea been listed?
  Opthea’s ordinary shares trade on the Australian Securities Exchange. The company also listed American Depositary Shares on The Nasdaq Global Select Market and later filed a Form 25 to voluntarily remove those ADSs from Nasdaq listing and registration.
• What recent corporate changes has Opthea disclosed?
  After not meeting primary endpoints in its Phase 3 wet AMD trials for sozinibercept, Opthea agreed with its DFA investors to discontinue development of sozinibercept in wet AMD and entered into a settlement of the DFA. The company has reported workforce reductions, changes in senior management and its board, and plans for a strategic review.
• What risks does Opthea highlight for investors?
  Opthea notes risks common to biotechnology companies, including the possibility of clinical trial failure, regulatory uncertainty, intellectual property challenges, funding needs, and dependence on research and development success. It characterizes investment in drug development companies as highly speculative.
• Where can investors find Opthea’s official disclosures?
  Opthea files reports with the U.S. Securities and Exchange Commission, including Forms 20‑F, 6‑K, and 25, and also lodges reports with the Australian Securities Exchange. These filings include financial statements, clinical and corporate updates, and information about its securities.