FDA Events for Opthea (OPT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Opthea (OPT).
Over the past two years, Opthea has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
sozinibercept. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
sozinibercept - FDA Regulatory Timeline and Events
sozinibercept is a drug developed by Opthea for the following indication: In Wet AMD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- sozinibercept
- Announced Date:
- March 3, 2025
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced the publication of sozinibercept Phase 2b data in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina.
AI Summary
Opthea Limited announced that its Phase 2b data for sozinibercept was published in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina. The study focused on treatment-naïve patients with wet age-related macular degeneration (wet AMD) and examined how different angiographic lesion characteristics affected treatment outcomes. Researchers looked at various choroidal neovascularization types, including occult, minimally classic, and predominantly classic lesions, while also considering the impact of retinal angiomatous proliferation (RAP). In patients with occult and minimally classic lesions excluding RAP, the combination therapy of sozinibercept with ranibizumab produced an additional average gain of 5.7 letters in visual acuity compared to ranibizumab alone. These findings, along with improvements in retinal anatomy, provide valuable insight and have helped shape the design of Opthea’s ongoing Phase 3 clinical program.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- February 26, 2025
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced the completion of its drug product Process Performance Qualification (PPQ) campaign for sozinibercept.
AI Summary
Opthea Limited announced it has successfully completed its Process Performance Qualification (PPQ) campaign for sozinibercept by producing three consecutive commercial-scale drug product batches. This achievement validates the company’s manufacturing process and supports its potential biologics license application filing for the treatment of wet age-related macular degeneration (wet AMD) during the first half of 2026.
The successful PPQ campaign builds on earlier milestones and shows that Opthea can consistently produce high-quality batches at a commercial scale. This consistency is critical as the company moves closer to potential approval and launch of sozinibercept. CEO Fred Guerard emphasized that this development strengthens the company's position as it prepares for upcoming clinical trial topline data readouts, which are expected in early and mid-2025. The accomplishment is an important step forward in Opthea's efforts to offer new treatment options for patients with wet AMD.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- February 18, 2025
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced that it has completed the final week 52 patient visit in COAST, the first of two Phase 3 pivotal trials investigating the superiority and safety of sozinibercept in combination with aflibercept (COAST) or ranibizumab (ShORe), compared to standard of care alone for the treatment of wet AMD.
AI Summary
Opthea Limited announced it has completed the final week 52 patient visit in the COAST trial, the first of two Phase 3 pivotal studies investigating a new treatment for wet age-related macular degeneration (wet AMD). The trial is testing sozinibercept combined with aflibercept to see if this combination is superior and safe compared to the standard care alone. Researchers are focusing on the improvement in patients’ best corrected visual acuity, measured from the start of the trial to week 52. Patients will also be followed for an additional year to assess long-term safety. The topline results from the COAST trial are expected in early Q2 of calendar year 2025, marking an important milestone in the development of a new treatment option aimed at delivering better visual outcomes and a fuller, healthier life for patients with wet AMD.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- February 18, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced that The topline results from both trials are anticipated in early Q2 CY25 (COAST) and mid-CY25 (ShORe).
AI Summary
Opthea Limited has reached an important milestone in its Phase 3 clinical program for treating wet age-related macular degeneration (AMD). The company recently completed the final week 52 patient visit for the COAST trial, which is designed to assess the safety and effectiveness of sozinibercept in combination with aflibercept. The topline results for this trial are anticipated in early Q2 CY25, promising timely updates on the therapy’s performance.
In addition to COAST, Opthea is running the ShORe trial, which studies sozinibercept combined with ranibizumab. The topline results for ShORe are expected in mid-CY25. Both trials focus on the improvement of visual outcomes in wet AMD patients, marking a critical step forward in the search for more effective treatments that could enhance patients' lives.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- January 7, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced that ShORe in mid-2025
AI Summary
Opthea Limited, a clinical-stage biopharmaceutical company, recently released promising Phase 1b trial results for its novel treatment, sozinibercept, in diabetic macular edema (DME). The trial demonstrated that when sozinibercept is combined with standard anti-VEGF-A therapy, it is safe and well-tolerated. Moreover, the study showed a clear dose-response benefit with improved visual acuity and reduced retinal thickness in patients who had persistent DME despite prior treatment.
Looking ahead, Opthea highlighted its focus on advancing treatments for wet age-related macular degeneration (wet AMD). The company announced that the ShORe trial is expected to report topline results in mid-2025. This development is part of a broader clinical program that also includes the anticipated COAST topline data in early Q2 2025, reflecting a strong commitment to addressing unmet medical needs in retinal diseases.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- January 7, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced that DME program to be advanced after wet AMD topline data readout anticipated for COAST in early CY Q2 2025
AI Summary
Opthea Limited announced promising developments in its clinical program for diabetic macular edema (DME). The company’s Phase 1b study showed that sozinibercept, used with aflibercept, was safe and demonstrated improved visual and anatomical outcomes in patients with DME. These early results support sozinibercept’s role as a novel VEGF-C/D “trap” to better prevent blood vessel growth and leakage in the retina.
Opthea’s immediate focus is on its upcoming Phase 3 wet AMD trials. The topline data for the COAST study is expected in early calendar year Q2 2025, with the ShORe study results anticipated in mid-2025. Following these data readouts, the company plans to further advance its clinical development program for DME, building on the encouraging performance observed in the Phase 1b trial.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- January 7, 2025
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced the publication of its Phase 1b trial of sozinibercept combination therapy in diabetic macular edema (DME) in the peer-reviewed journal Translational Vision Science & Technology (TVST), issued on December 19, 2024.
AI Summary
Opthea Limited announced the publication of its Phase 1b trial data on sozinibercept combination therapy in diabetic macular edema (DME) in the peer-reviewed journal Translational Vision Science & Technology (TVST) on December 19, 2024. This study focused on previously treated DME patients who had persistent disease despite anti-VEGF-A therapy. The open-label, multicenter, dose-escalation trial evaluated nine patients, with sozinibercept dosages of 0.3, 1, or 2 mg used in combination with aflibercept. The primary objective was to assess safety, and the results showed that sozinibercept was well tolerated without dose-limiting toxicities. Furthermore, the trial demonstrated a dose-response relationship, where higher doses led to increased improvements in best-corrected visual acuity and significant reduction in central subfield thickness, supporting sozinibercept’s potential as a novel VEGF-C/D “trap” to enhance treatment outcomes in DME.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- October 8, 2024
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced three senior hires as the Company continues to prepare for the sozinibercept Phase 3 topline data readouts of COAST anticipated in early Q2 calendar year 2025 and ShORe in mid calendar year 2025.
AI Summary
Opthea Limited, a clinical-stage biopharmaceutical company focused on treating retinal diseases, has made three key senior hires as it prepares for important Phase 3 topline data readouts for its lead candidate, sozinibercept. The Phase 3 trials, COAST and ShORe, are expected to report results in early Q2 and mid calendar year 2025, respectively. These developments are central to the company’s plans for subsequent US and international regulatory submissions.
The new appointments include Dr. Parisa Zamiri as Chief Medical Officer, Tom Reilly as Chief Financial Officer, and Anand Sundaram as Vice President Marketing. These hires not only bring deep expertise in retina research, financial leadership, and commercial strategy but also strengthen Opthea’s readiness for upcoming clinical milestones and regulatory steps.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- September 18, 2024
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced the completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept.
AI Summary
Opthea Limited announced a major milestone with the completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, a potential treatment for wet age-related macular degeneration (wet AMD). The PPQ campaign involved producing three consecutive commercial-scale batches, which validates the company’s manufacturing process and confirms their ability to consistently produce a high-quality drug substance. This achievement is an important step toward de-risking the program and moving closer to a potential Biologics License Application (BLA) filing for sozinibercept. The successful campaign also positions Opthea well to support their upcoming drug product PPQ campaign and supplies for initial launch materials. The company plans to provide an update on the progress of the drug product PPQ campaign in early 2025, further highlighting its commitment to advancing this promising treatment option.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- September 18, 2024
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced that Progress update of drug product PPQ campaign expected in early 2025
AI Summary
Opthea Limited has reached an important manufacturing milestone by successfully producing three consecutive commercial-scale batches of sozinibercept, a potential therapy for wet age-related macular degeneration. This achievement demonstrates the company’s ability to consistently manufacture a high-quality drug substance, which is a critical step toward a potential biologics license application filing. The current success in the Process Performance Qualification (PPQ) campaign reinforces the company’s plans to move forward in its development program for wet AMD. Looking ahead, Opthea expects to share a progress update on its drug product PPQ campaign in early 2025.
This update will provide further insights into the manufacturing process and validate the drug product’s consistency and readiness for broader supply. The milestone places Opthea in a strong position to support upcoming launch materials and continue advancing its clinical trials for wet AMD treatment.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- May 28, 2024
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced that Topline data from both pivotal trials expected in mid-CY2025
AI Summary
Opthea Limited announced that topline data from its two pivotal Phase 3 trials, COAST and ShORe, are expected in mid-CY2025. These trials are designed to evaluate the safety and efficacy of sozinibercept when used in combination with standard-of-care anti-VEGF-A therapies for treating wet age-related macular degeneration (wet AMD).
The global Phase 3 program enrolled 1,984 treatment-naïve wet AMD patients. The COAST trial combines sozinibercept with aflibercept, while the ShORe trial pairs it with ranibizumab. The study aims to show superior visual outcomes compared to using anti-VEGF-A therapy alone. The expected topline data will provide critical insights that may support a future biologics license application, potentially transforming treatment options for wet AMD patients.
Read Announcement- Drug:
- sozinibercept
- Announced Date:
- May 28, 2024
- Indication:
- In Wet AMD
Announcement
Opthea Limited announced that it has now completed enrollment in both the COAST and ShORe trials constituting its pivotal Phase 3 clinical program. This program is designed to assess the safety and superior efficacy of sozinibercept in combination with standard-of-care anti-VEGF-A therapies compared to standard of care alone for the treatment of patients with wet AMD.
AI Summary
Opthea Limited announced that it has completed enrollment for its pivotal Phase 3 clinical program, which includes the COAST and ShORe trials. These trials are designed to assess the safety and enhanced efficacy of sozinibercept when used in combination with standard-of-care anti-VEGF-A therapies, compared to the standard of care alone, for patients with wet age-related macular degeneration (wet AMD).
The program will evaluate whether adding sozinibercept to existing treatments can offer superior visual outcomes. The COAST trial combines sozinibercept with aflibercept, while the ShORe trial pairs it with ranibizumab. Enrollment reached 1,984 treatment-naïve patients across both studies, making this one of the largest Phase 3 programs for wet AMD. The trial results are expected to contribute valuable insights, with topline data anticipated mid-CY2025.
Read Announcement
Opthea FDA Events - Frequently Asked Questions
As of now, Opthea (OPT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Opthea (OPT) has reported FDA regulatory activity for sozinibercept.
The most recent FDA-related event for Opthea occurred on March 3, 2025, involving sozinibercept. The update was categorized as "Publication," with the company reporting: "Opthea Limited announced the publication of sozinibercept Phase 2b data in the peer-reviewed journal Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina."
Currently, Opthea has one therapy (sozinibercept) targeting the following condition: In Wet AMD.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:OPT) was last updated on 7/13/2025 by MarketBeat.com Staff
