Doctors

stimuleyes information for doctors

chronic dry eye treatment option for doctors

Make StimulEyes Your First Treatment for DED

Regenerative Eye Solution for Chronic Dry Eye Disease (DED)

StimulEyes is a product based on the clinical science of Regenerative Medicine that may provide the required broad-spectrum solution approach. Our biological solution focuses on reducing inflammation and providing the growth factors which may increase positive outcomes.

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prescription dry eye solution

 

Indications for Use and Prescribing

The primary indication for the use of StimulEyes is for chronic DED.

Duly licensed providers may prescribe StimulEyes for patients and execute that order directly through M2 Biologics. Therefore, the doctor can directly provide the solution and give comprehensive instructions in the doctor's office. StimulEyes requires no stringent environmental storage requirements, can be stored at room temperature, and has a shelf life of up to one year.

Dosing protocols and use are at the discretion of the provider. Suggested use is one drop in each eye twice per day, ideally morning and night. Depending on the severity of the condition, the patient may be instructed to increase the frequency of treatment or additional drops per treatment. A member of the M2 Biologics Clinical Team is available to discuss dosing alternatives with the prescribing provider.

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The Matrix of StimulEyes

  • Growth Factors (partial listing)
    • EDF - Epidermal Growth Factor
    • PDGF - Platelet Derived Growth Factor
    • TGF, Beta 1 - Transforming Growth Factor
    • bFGF - Fibroblast Growth Factor
    • ANG-2 - Angiopoietin 2
    • VEGF - Vascular Endothelial Growth Factor
    • MMP-9 - Matrix Metallopeptidase 9 - Tissue stimulating tissue remodeling
    • TIMP 1,2,3,4 - Tissue remodeling
    • IL 10-and IL-1ra - Anti-inflammatory activity
    • MPO - Myeloperoxidase - Antimicrobial activity
  • Bioactive Proteins
    • Cytokines - Function as anti-inflammation and cell signaling mediators
  • Hyaluronic Acid
    • Provides soothing and helps maintain moisture
  • 0.9% NaCl Isotonic Saline

 

FDA Regulations

EVs from culture expanded cells (exosomes) used to treat diseases and conditions in humans are regulated by the FDA as HCT/P drugs under section 351 of the Public Health Service Act (42 U.S.C. 262) and are subject to premarket review and approval requirements. Conversely, EVs from secreted body fluids, e.g., amniotic fluid (Cytosomes™), are not considered HCT/Ps by the FDA (21 CFR 1271.3(d)) and are regulated as a non-HCT/P biologic.

The FDA is clear in their language that their primary mission is to protect patient safety. Amniotic fluid has been studied for decades and its role in tissue growth, tissue repair and immune modulation in animal models and humans is well documented within the scientific literature. These long-term clinical data, together with the minimal manipulation required to isolate pure amniotic fluid, has established AF as a safe and effective tissue for use in research and clinical trials (conditional upon appropriate manufacturing practices by a qualified laboratory).

Patients are encouraged to report any negative side effects of prescription drugs to the FDA at www.FDA.gov/medwatch or by calling 1-800-FDA-1088

 

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