Opthea reports phase 3 trial results for eye treatment

Opthea Ltd (NASDAQ:OPT), a biopharmaceutical company specializing in the development of novel therapies to treat eye diseases, with a current market capitalization of $464.54 million, announced today the topline results from its COAST Phase 3 clinical trial. The study evaluated the efficacy and safety of the company’s lead drug candidate in patients with wet age-related macular degeneration (wAMD), a chronic eye disorder that causes loss of vision in the center of the field of vision.

The trial results, which are a significant milestone for the company, indicated that the treatment met the primary endpoint of improved visual acuity. The detailed data from the study is expected to support regulatory submissions for marketing approval. Opthea’s CEO, Frederic Guerard, stated, "These positive results from the COAST Phase 3 trial represent a major achievement for Opthea and a promising development for patients with wAMD."

The announcement was made through a Form 6-K filing with the U.S. Securities and Exchange Commission (SEC), a requirement for foreign companies listed on U.S. markets to provide information that may affect their share price. The filing, made public on Monday, March 24, 2025, ensures transparency and provides investors with timely access to important company developments. According to InvestingPro data, the stock has shown significant volatility with a beta of 1.64, making such developments particularly impactful for investors.

Opthea’s success in the COAST trial is a key step in the drug’s development pathway and could potentially lead to a new treatment option for the millions of people affected by wAMD globally. The company will likely proceed with discussions with regulatory authorities to bring the drug to market.

The news is particularly relevant for investors and stakeholders in the biotech and pharmaceutical sectors, as it may have implications for Opthea’s market position and future revenue streams. InvestingPro analysis reveals the company is currently burning through cash with an EBITDA of -$183.2 million, while analyst price targets range from $8 to $18, suggesting significant upside potential if commercialization succeeds. As the company prepares for potential commercialization, the focus will now shift to the regulatory review process and the planning of a strategic launch.

This report is based solely on the information provided in the company’s SEC filing and does not include any speculative content. Further details on the trial’s outcomes and next steps for Opthea will be closely monitored by the investment community. For deeper insights into Opthea’s financial health and market position, investors can access additional ProTips and comprehensive financial metrics through InvestingPro.

In other recent news, Opthea Limited has reported positive results from its Phase 2b clinical trial for sozinibercept, a treatment targeting wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). The trial demonstrated a statistically significant gain in visual acuity when sozinibercept was combined with ranibizumab, compared to ranibizumab alone. This development is crucial as it informs the ongoing Phase 3 clinical program, which includes the COAST and ShORe trials, with results anticipated in 2025. Additionally, Opthea announced the completion of the final patient visit in the COAST study, marking a significant milestone in its clinical evaluation process. The company has also completed its Drug Product Process Performance Qualification (PPQ) campaign, ensuring that its manufacturing processes meet the required quality standards. Opthea’s recent mid-year financial results were also released, detailing the company’s continued focus on advancing its therapeutic pipeline. These developments are being closely watched by investors and stakeholders, as they could influence Opthea’s future prospects in the biopharmaceutical sector.

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