Opthea reports positive Phase 2b wet AMD trial results

MELBOURNE, Australia and PRINCETON, N.J. - Opthea Limited (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company with a market capitalization of $735 million, has announced the publication of Phase 2b clinical trial data for sozinibercept, its novel therapy for wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). The company’s stock has shown strong momentum, delivering a 54% return over the past six months, according to InvestingPro data. The study, published in the peer-reviewed Ophthalmic Surgery, Lasers and Imaging Retina journal, details the efficacy of sozinibercept in combination with ranibizumab, a current standard-of-care treatment.

The trial demonstrated that sozinibercept combination therapy resulted in a statistically significant additional 5.7 letter mean gain in best corrected visual acuity (BCVA) over 24 weeks compared to ranibizumab alone in a subgroup of patients. This subgroup, which excluded patients with retinal angiomatous proliferation (RAP) and included those with occult and minimally classic lesions, represented 73% of the trial’s patient population.

The study’s findings are expected to inform the ongoing Phase 3 clinical program, which includes two fully enrolled trials, COAST and ShORe. These trials aim to establish the safety and superior efficacy of sozinibercept combination therapy compared to anti-VEGF-A monotherapy in wet AMD. Topline data readouts for COAST and ShORe are anticipated in early Q2 CY 2025 and mid-CY 2025, respectively.

Wet AMD is the leading cause of vision loss in the elderly, affecting approximately 3.5 million individuals in the US and Europe. Despite existing treatments, many patients do not achieve optimal vision outcomes. Opthea’s sozinibercept has received Fast Track Designation from the US FDA for the treatment of wet AMD and aims to provide superior vision outcomes for patients.

The Phase 2b trial included 366 treatment-naïve wet AMD patients and met its pre-specified primary efficacy endpoint. The combination therapy also showed favorable secondary outcomes, including more patients gaining vision of 10 or more EDTRS letters, with improved anatomy, reduced swelling, and vascular leakage, along with a favorable safety profile. While the clinical results are promising, InvestingPro analysis indicates the company is currently trading above its Fair Value, with analysts setting price targets ranging from $8 to $18 per share. InvestingPro subscribers have access to 10 additional key insights about Opthea’s financial health and market position.

Investment in biopharmaceutical companies like Opthea is considered highly speculative due to the inherent risks associated with drug development. The company’s financial metrics from InvestingPro reveal a current ratio of 1.57 and rapid cash consumption, with negative EBITDA of $183.2 million in the last twelve months. Despite these challenges, successful clinical trials and regulatory approvals can lead to significant advancements in treatment options for diseases such as wet AMD. The company maintains a moderate debt level, with a total debt to capital ratio of 0.23, providing some financial flexibility as it progresses through clinical development.

This news is based on a press release statement from Opthea Limited and provides insights into the progress of sozinibercept’s clinical development.

In other recent news, Opthea Limited has reported positive results from its Phase 2b clinical trial for a treatment targeting wet age-related macular degeneration (wet AMD). The trial met its primary endpoint, demonstrating efficacy in improving visual acuity in patients. This development marks a significant milestone for Opthea as it continues to advance its drug pipeline. Additionally, Opthea announced its financial results for the first half of the fiscal year, highlighting its focus on developing therapies for eye diseases.

In another update, Opthea completed its Drug Product Process Performance Qualification (PPQ) campaign, a crucial step in ensuring its products meet quality standards required for pharmaceuticals. This achievement is essential for moving towards potential regulatory approval and commercial manufacturing. Furthermore, the company has completed the final patient visit in the COAST study, a pivotal clinical trial for its leading drug candidate aimed at treating a form of age-related macular degeneration.

Opthea also announced its participation in the upcoming Oppenheimer Healthcare Conference, where CEO Frederic Guerard will present the company’s progress and developments. This conference provides an opportunity for Opthea to discuss its strategic direction and engage with the healthcare community and investors. These recent developments underscore Opthea’s ongoing efforts to innovate and address unmet needs in ophthalmology.

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