Clearside Biomedical Shares Insights from Recent CLS-AX Study

New Data Insights from Clearside Biomedical's Recent Trial

Clearside Biomedical, Inc. (NASDAQ: CLSD), a pioneering biopharmaceutical company, is making significant strides in the realm of ocular health. The company, focused on innovatively delivering therapies to the back of the eye through the suprachoroidal space (SCS), has unveiled crucial insights from the ODYSSEY Phase 2b clinical trial presented at the recent Angiogenesis, Exudation, and Degeneration 2025 meeting. This meeting serves as a key platform for advancing the understanding and treatment of sight-threatening diseases.

Overview of the ODYSSEY Phase 2b Clinical Trial

The ODYSSEY trial was a meticulous, randomized, double-masked, parallel-group study that spanned 36 weeks. It evaluated the efficacy of CLS-AX, an axitinib injectable suspension, in individuals diagnosed with neovascular age-related macular degeneration (wet AMD). With a total of 60 participants, the trial aimed to assess the performance of CLS-AX against the traditional treatment of aflibercept.

Significant Findings from the Trial

Roger Goldberg, MD, MBA, from Bay Area Retinal Associates Medical Group, shared compelling data from the trials, highlighting two subgroup analyses essential for informing the design of upcoming Phase 3 clinical trials. The first analysis focuses on the positive outcomes observed with CLS-AX administration, revealing that a notable percentage of treatment-naïve patients maintained stable visual acuity with minimal interventions.

Encouraging Subgroup Analyses Results

The outcomes from the first subgroup analysis emphasized the benefits of targeting treatment-naïve patients. Impressively, during the ODYSSEY trial, 67% of participants receiving CLS-AX did not require additional treatment for six months. This significant finding suggests that CLS-AX has the potential to simplify treatment protocols and improve patient compliance while focusing on a broader population base.

Understanding the Need for Exclusion Criteria

Further insights emerged from the second subgroup analysis, which suggests the advantage of excluding certain participants from the Phase 3 trial. This analysis pointed out that participants with significant non-disease related changes in best corrected visual acuity could skew the results. By refining the participant criteria, Clearside aims to enhance the reliability of Phase 3 trial outcomes.

Future Directions for CLS-AX

Victor Chong, MD, MBA, Clearside’s Chief Medical Officer, articulated the importance of these analyses in shaping future clinical directions. These insights will directly inform the design strategies for the Phase 3 non-inferiority trials, ensuring that the data obtained translates effectively into real-world treatment scenarios.

Upcoming Presentations Highlighting CLS-AX

As Clearisde continues to unveil findings from the ODYSSEY trial, future presentations are scheduled, including:

The Macula Society 48th Annual Meeting (February 12-15, 2025)
Presentation Title: Top Line Results from ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-related Macular Degeneration
Presenter: Thomas A. Ciulla, MD, MBA, Chief Medical Advisor-Retina at Clearside Biomedical.

5th Annual Wet AMD & Diabetic Eye Disease Drug Summit (March 18-20, 2025)
Presentation Title: Transforming wAMD Treatment: Long-Lasting, Flexible Dosing with Suprachoroidal TKI Delivery
Presenter: Victor Chong, MD, MBA, Clearside’s Chief Medical Officer.

About CLS-AX and Its Mechanism

CLS-AX represents a proprietary formulation of axitinib designed for suprachoroidal injection, enabling novel delivery strategies that may surpass existing treatments. As a potent tyrosine kinase inhibitor, axitinib blocks multiple VEGF receptors integral to the progression of retinal diseases like wet AMD.

Potential Advantages Over Current Treatments

This new approach stands to offer various therapeutic benefits over traditional solutions by targeting disease processes more efficiently and minimizing potential risks associated with non-targeted treatments. The therapeutic implications could vastly improve outcomes for patients who have limited success with current therapies.

About Clearside Biomedical, Inc.

Clearside Biomedical, Inc. is dedicated to transforming the treatment landscape for ocular diseases. By utilizing its proprietary SCS Microinjector, the company is committed to enhancing patient outcomes through innovative delivery methods. Currently, the company is also working on additional therapies targeting other retinal diseases, further solidifying its position as a leader in ophthalmic innovation.

Frequently Asked Questions

What is the CLS-AX treatment?

CLS-AX is an injectable suspension of axitinib, developed for treating conditions like wet AMD through targeting delivery into the suprachoroidal space.

How does the ODYSSEY trial contribute to future research?

The insights gained from the ODYSSEY trial will shape the designs of future clinical trials, enabling more effective patient criteria and potentially better outcomes.

What are the next steps for Clearside Biomedical?

Clearside will continue with the planned Phase 3 trials for CLS-AX and disseminate findings through various upcoming conference presentations to gather further insights.

Who is the target demographic for CLS-AX?

The treatment primarily targets patients with neovascular age-related macular degeneration who are either new to treatment or have shown limited response to current therapies.

How does Clearside's technology differ from existing options?

Clearside’s suprachoroidal delivery method allows for targeted treatment at the back of the eye, potentially leading to fewer injections and better patient adherence compared to traditional methods.

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