Ocular Therapeutix™ Announces First Subjects Screened in Phase 3 Pivotal Clinical Trial of AXPAXLI™ in Wet AMD
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The initiation of the Phase 3 SOL-1 clinical trial for AXPAXLI, an axitinib intravitreal implant, presents a significant development in the treatment of wet age-related macular degeneration (wet AMD). The potential of AXPAXLI to extend the time between treatments addresses a critical need in the patient community for reduced treatment frequency, which currently burdens both patients and healthcare providers. The earlier studies suggesting favorable safety and biological activity profiles indicate that, if successful, AXPAXLI could indeed revolutionize the standard of care in wet AMD therapy.
From a research perspective, the move into Phase 3 trials signals a maturation of the technology that, if approved, could lead to a shift in market dynamics. The commitment to patient-centric treatments underscores a broader industry trend towards therapies that not only improve clinical outcomes but also enhance quality of life by minimizing treatment-related inconveniences. This aligns with current health economic models that emphasize both efficacy and the overall impact of a treatment on patient lifestyle.
Ocular Therapeutix's progression into late-stage clinical trials with AXPAXLI may have downstream effects on its market position and investor confidence. Given the prevalence of wet AMD and the growing aging population, the market for effective treatments is substantial and expanding. A successful outcome from the Phase 3 SOL-1 study could position Ocular Therapeutix as a leader in the ophthalmic treatment space, potentially capturing a significant market share. The FDA's agreement on the Special Protocol Assessment (SPA) Agreement Modification also adds a layer of regulatory confidence that may be viewed favorably by stakeholders.
Investors will likely monitor the trial's progress closely, as positive results could lead to a surge in the company's stock value due to the high demand for innovative wet AMD treatments. Conversely, any setbacks could have a negative impact. Therefore, the trial outcomes are crucial for both the company's financial health and its strategic positioning in the biopharmaceutical industry.
Entering a Phase 3 clinical trial is a pivotal moment that requires rigorous adherence to regulatory standards and ethical considerations, especially given the SPA Agreement Modification with the FDA. This agreement indicates a pre-approval of the study's design, which can expedite the review process post-trial completion. It is crucial for Ocular Therapeutix to maintain transparency and compliance throughout the trial to ensure that any potential approval is not delayed by regulatory issues.
Furthermore, the legal landscape surrounding biopharmaceuticals is complex, with intellectual property rights playing a key role in maintaining competitive advantage. Should AXPAXLI prove successful, Ocular Therapeutix will need to navigate patent law effectively to protect their innovation, while also preparing for the possibility of future litigation from competitors or challenges regarding patent validity.
Phase 3 SOL-1 study will evaluate the efficacy and safety of AXPAXLI in wet AMD
BEDFORD, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the first three subjects have been screened and received their first aflibercept injection in the Phase 3 SOL-1 clinical trial of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD). The Company previously announced FDA agreement on its Special Protocol Assessment (SPA) Agreement Modification on January 25th.
“The screening of these subjects in the pivotal Phase 3 SOL-1 trial of AXPAXLI marks an exciting milestone for Ocular Therapeutix,” said Antony Mattessich, CEO of Ocular Therapeutix. “AXPAXLI has demonstrated promising durability, biological activity, and a favorable safety profile in earlier studies. We believe that AXPAXLI could set a new standard in wet AMD therapy by significantly extending time between treatments. If successful, this first-of-its-kind implant could reduce injection burden for patients and doctors alike while leading to better long-term outcomes.”
“Wet AMD patients need options that provide sustained therapy while minimizing their need for frequent injections and office visits,” said Allen Hu, M.D., a principal investigator in the SOL study and vitreoretinal surgeon at Cumberland Valley Retina Consultants. “I am thrilled to be participating in research that could shift the existing treatment paradigm for patients with wet AMD.” Dr. Hu is an active principal investigator of innovative technologies for the treatment of macular degeneration, diabetic retinopathy and retinal vascular disorders, having participated in over 40 clinical trials over the past 10 years.
“Clinical trials like the SOL-1 study for AXPAXLI represent a critical step forward in our pursuit of more patient-centric treatments for wet AMD. As a clinician dedicated to advancing retinal care, I am excited to contribute to the development of potentially transformative solutions for our patients,” said Dilsher Dhoot, M.D., a principal investigator in the SOL-1 study and vitreoretinal surgeon at California Retina Consultants. Dr. Dhoot has contributed to over 35 clinical trials in the past decade as an active principal investigator, pioneering new approaches in advancing the field of retinal therapies.
About AXPAXLI
AXPAXLI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and other retinal diseases.
About Wet AMD
Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14 million individuals globally and 1.6 million in the United States alone (2022 Market Scope® Retinal Pharmaceuticals Market Report). Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment, patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies include repeated intraocular injections every 1 to 4 months, treatment-related adverse events, patient compliance, and lack of vision improvement.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology ELUTYX™. Ocular Therapeutix’s first commercial drug product, DEXTENZA®, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets include: AXPAXLI (axitinib intravitreal implant), currently in a pivotal Phase 3 trial for the treatment of wet AMD and a Phase 1 clinical trial for the treatment of diabetic retinopathy; PAXTRAVA™ (travoprost intracameral implant, also known as OTX-TIC), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease, both of which have completed Phase 2 clinical trials.
Forward Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the development and regulatory status of the Company’s product candidates, including the timing, design, and enrollment of the Company’s pivotal trials of AXPAXLI (also called OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI; and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA or any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval; the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA; the initiation, design, timing, conduct and outcomes of clinical trials, including the SOL-1 trial; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under the SPA; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not agree that the data generated by the SOL-1 trial supports potential marketing approval; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; the Company’s ability to enter into strategic alliances or generate additional funding on a timely basis, on favorable terms, or at all; and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Investors
Ocular Therapeutix
Donald Notman
Chief Financial Officer
dnotman@ocutx.com
or
ICR Westwicke
Chris Brinzey, 339-970-2843
Managing Director
chris.brinzey@westwicke.com
Media
ICR Westwicke
Ben Shannon, 443-213-0495
ben.shannon@westwicke.com
