FAQ

For Patients

 

Is it FDA Approved?

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).

 

Is it covered by insurance?

At this time StimulEyes is not covered by insurance. Our team is working to secure approval by insurance companies, Medicaid, and Medicare for reimbursements. As of now, StimulEyes is a patient-pay prescription.

 

What makes StimulEyes different from its competitors?

Unlike other market-leading products that are used to treat Dry Eye Disease, StimulEyes is classified as a biologic, using human elements like tissues and proteins. It contains no chemicals, steroids, or antibiotics. Instead, the biological makeup is hyaluronic acid (for lubrication), cytokines (for anti-inflammation), and growth factors (which may provide for cell repair, blood vessel growth, anti biological activities, and tissue regeneration.)

 

What is its composition?  

StimulEyes relies on its unique matrix, which is derived safely and ethically from human amniotic fluid. Its biological makeup is hyaluronic acid, cytokines, and growth factors.

 

What were the results of your clinical trials? 

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. As such, clinical trials are not required.  However, M2 Biologics did provide the pre-released product to a number of patients and determined the results were promising. Please read these patient testimonials.

 

How do we know it will work?

StimulEyes is made from the same matrix that has been used to successfully treat hundreds of instances of chronic wounds, burns, lung disorders and arthritic knees, shoulders and other joints. Knowing how well the matrix works on these complex medical conditions and how it functions on a cellular level gives us a high degree of clinical confidence for the success of StimulEyes.

 

Can I get samples?

 

What is the standard dosage?

Your doctor will determine the frequency you use StimulEyes and what the dosage will be. In most cases, a recommendation likely will be one drop in each eye, twice a day. If you wear contact lens, they should be removed and not replaced for at least 15 minutes. Also, with your doctor’s approval, StimulEyes may perform best in the absence of other eye drops.

 

 

 

For Doctors

How much does it cost the patient?

Request price sheet

 

Can it be stocked?

Yes

 

What are the doctor’s costs?

Request price sheet

 

What do profit margins look like? 

Request price sheet

 

How does the doctor prescribe?

Each doctor needs to fill out a brief application providing the level of information for M2 Biologics to determine licensure for prescribing (link here:  New Account Registration). The account can then be set up for the doctor or the entire practice. Orders are made by the doctor (through M2 Biologics sales professional) and the product is delivered to the doctor. They then prescribe a course of treatment for dry eye patients and dispense StimulEyes from their offices.

 

What information is provided for the doctor?

Each doctor will have access to a clinical information brochure, as well as a consumer brochure that provides more information on StimulEyes. Detailed clinical information and discussions are available with M2 Biologics. More detailed clinical questions should be emailed to clinicalquestions@m2biologics.com. A member of the clinical staff will respond.

 

Is StimulEyes covered by insurance?

  • Medicare / Medicaid:
    • StimulEyes does not have a specific Q code assigned to it via the Centers for Medicare and Medicaid Services (CMS). We are currently engaged in the lengthy process of securing a Q code.
  • Commercial Insurance:
    • The competing products of Restasis and Xiidra are reimbursed by some health plans. The ones that approve them are normally Taft-Hartley (Union plans) and other plans considered high-end Cadillac plans. The whole process of getting a product approved for reimbursement as a prescribed product rather than a product used with surgical applications and services is quite prolonged.

      The good news in terms of out-of-pocket expense for a patient using StimulEyes compared to Restasis or Xiidra is that even with partial coverage through private insurance, StimulEyes costs less for the patient.

      Most employers offer Healthcare Savings Accounts (HSA) and Flexible Savings Accounts (FSAs), allowing employees to put a certain amount of money aside pretax from payroll to cover non-reimbursed healthcare expenses. This money can be used for prescription medications.

 

What protocols are used for treatment?

Each doctor will determine how StimulEyes is used. For most cases of chronic dry eye, a recommendation would be one drop in each eye two times per day. For other conditions such as blepharitis or corneal conditions, it can be prescribed at the discretion of the doctor. If the patient is a contact lens wearer, contacts should be removed and not replaced for at least 15 minutes upon treatment. It also is recommended that the patient not use any other eye drops. StimulEyes has been formulated for the treatment of chronic dry eye (CDE). At this time, it is not recommended as a treatment for other eye conditions. Further clinical discussions may be addressed by email to clinicalquestions@m2biologics.com

 

What makes StimulEyes potentially more efficacious than other biologic-based eye drops?

While there are certainly similarities in the makeup or matrix of human amniotic-based products, better outcomes from the use of StimulEyes should be attributed to the viability of the proteins it contains. Its protein viability is nearly as high a state after sterilization as when first harvested. Even in the absence of preservatives,  StimulEyes’s protein viability remains impressively high.

 
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