Ocular Therapeutix™ Completes Enrollment of the HELIOS Clinical Trial of OTX-TKI for the Treatment of Diabetic Retinopathy
Diabetic retinopathy is a leading cause of vision loss in working-age adults, affecting approximately 140 million individuals around the world, including 8.4 million people in
“Millions of people suffer from diabetic retinopathy. Today, the current standard of care in non-proliferative stages is primarily ‘watchful waiting’, as frequent anti-VEGF injections and office visits pose a significant treatment burden primarily for the working-age population. Many patients frequently progress to more severe vision-destroying disease before they seek treatment, making diabetic retinopathy one of the leading causes of blindness among working-age adults in the U.S.,” said
The HELIOS Phase 1 trial is a multi-center, prospective, masked, 2:1 randomized, controlled
OTX-TKI 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 age-related macular degeneration (wet AMD), diabetic retinopathy and other retinal diseases.
About Diabetic Retinopathy
Diabetic retinopathy is a chronic, progressive disease driven by elevated levels of blood glucose and depleted levels of oxygen causing damage to blood vessels in the retina. Diabetic retinopathy is among the most common microvascular complications of diabetes and is a leading cause of blindness globally. Diabetic retinopathy can take time to develop, and may progress from early, mild, non-proliferative diabetic retinopathy (NPDR) to moderate and then severe NPDR and eventually to proliferative diabetic retinopathy (PDR). As patients progress from mild to severe NPDR, the risk of developing proliferative disease increases. PDR is the most serious stage of the disease and develops when areas of the retina that are starved for nourishment and oxygen, triggering the proliferation of new blood vessels via secretions of vascular endothelial growth factor (VEGF). Diabetic macular edema (DME), an accumulation of fluid in the macula, can occur at any stage of diabetic retinopathy. The current standard of care for NPDR is watchful waiting, although damage to blood vessels in the retina is ongoing in the background, with anti-VEGFs used more commonly when the disease has progressed to the proliferative stage. Regular eye examinations are crucial for early detection and prevention of diabetic retinopathy.
There were an estimated 8.4 million cases of diabetic retinopathy in
Forward Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA® or any of the Company’s products or product candidates; the development and regulatory status of the Company’s product candidates, such as the Company’s development of, timing of, and prospects for approvability of OTX-TKI for the treatment of retinal diseases including wet AMD and diabetic retinopathy including the timing of planned pivotal clinical trials, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, and OTX-CSI for the chronic treatment of dry eye disease; the Company’s plans to advance the development of its product candidates or preclinical programs; the Company’s ability to fund the planned and future development of its product candidates, whether through strategic alliances or other fundraising; the potential utility of any of the Company’s product candidates; the size of potential markets for the Company’s product candidates; 2023 financial guidance, including estimated net product revenue; the sufficiency of the Company’s cash resources; 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, including the conduct of post-approval studies, 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, timing, conduct and outcomes of clinical trials, whether clinical trial data will be indicative of the results of subsequent clinical trials in the same or other indications or that interim data will be indicative of the full data from a clinical trial, uncertainties as to the timing and availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s ability to enter into and perform its obligations under collaborations and the performance of its collaborators under such collaborations, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the Company’s ability to meet supply demands, the Company’s ability to generate its projected net product revenue and in-market sales on the timeline expected, if at all, the sufficiency of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, any additional financing needs, the Company’s ability to recruit and retain key personnel, and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the
Chief Financial Officer
Source: Ocular Therapeutix, Inc.