NOVEL OMEZA® OCM™ WOUND MATRIX CLINICAL STUDY IN VENOUS LEG ULCERS HAS COMPLETED ENROLLMENT AND FINAL DATABASE LOCK. FULL RESULTS TO BE SUBMITTED TO PEER REVIEW JOURNAL

News provided by

Jun 05, 2024, 07:00 ET

SARASOTA, Fla., June 5, 2024 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marinebased therapies for wounds that are hard to treat, today announced completion of a multi-center open label study comparing OCM™ Wound Matrix to standard of care when treating chronic venous leg ulcers. The primary objectives of the trial were to evaluate the safety profile of OCM™ Wound Matrix and to evaluate the change in ulcer size compared to standard of care. Secondary objectives included evaluating changes in patients' quality of life and changes in bacterial fluorescence using the MolecuLight Device (MolecuLight i:X, MolecuLight Inc., Toronto CA).

A total of 33 patients were evaluated in the trial, received multilayer compression therapy and were imaged with MolecuLight. All patients were seen weekly for wound evaluation and dressing changes. 18 patients were treated with OCM™, a drug/device containing cold water fish peptides and other pharmaceutical-grade components. OCM™ creates an absorbable matrix which conforms to the wound bed and supports the synthesis of new tissue. 15 patients were treated with standard of care alone.

Patient demographics of those enrolled within the trial:

Ages ranged from 35-84
Average age of patients was 62.7 years
Median age of patients was 64 years
24 Caucasian
2 Hispanic
7 African-American

The age of the wounds studied ranged from 4 to 100 weeks, with an average age of 27 weeks. Additionally, the initial size of wounds ranged from 2.13 cm²to 28.7cm², with an average wound size of 12.9cm². Comorbidities of the patients included hypertension, atrial fibrillation, diabetes, hyperlipidemia, gout, psoriasis, opioid addiction, pituitary brain tumor, shingles, hypothyroidism, hypercholesterolemia, neuropathy and stroke.

"Results from Omeza's Venous Leg Ulcer trial not only demonstrate the clinical benefits of OCM™ in the treatment of venous leg ulcers, but also supports other independent clinical findings validating its effectiveness in reducing the bacterial burden often found within hard-toheal wounds. The MolecuLight images taken of wounds in this trial provide visual verification of reduced bacteria, suggesting improvement in overall size (percent area reduction)", reported Dr. Suzanne Bakewell PhD, Omeza's Chief Scientific Officer.

Venous Leg Ulcers sufferers are still a population with a high level of need for new therapies: Millions of Americans suffer with open, draining, painful venous leg ulcers that can take months or years to heal. Multilayer compression, the standard of care, heals less than 50% of these wounds at 12 weeks. In addition to the personal suffering, the economic impact exceeds one billion dollars annually. Common characteristics of VLU's include edema, inflammation, biofilm colonization, and decreased perfusion. Controlling edema with multilayer compression wrapping is the cornerstone of treatment. New therapies are required to increase the current success rate of wound healing in these patients who may have various co-morbidities which underly the etiology of hard to heal wounds.

References:

¹ https://www.jvascsurg.org/article/S0741 -5214(22)02154 -1/fulltext

About OMEZA

Omeza® is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising containing cold water fish peptides and other pharmaceuticalgrade components designed to reduce inflammation, increase tissue proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Founded in 2014, the company currently markets OCM™ for the treatment of nonhealing wounds. OCM™ is also being evaluated in real-world settings and in multiple clinical trials to compare the effects of OCM™ versus standard of care on wound healing, pain reduction, quality of life, and other secondary endpoints in patients with diabetic ulcers, chronic venous leg ulcers, and multiple other wound types. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida.

Media Contacts: Bernadette Cupit
[email protected]
908-334-4554

SOURCE Omeza LLC