FAQ

For Patients

 

Is it FDA approved?

  • StimulEyes is made up of human tissue and is known as an allograft, subjecting it to regulation by the FDA laws covering human tissue known as Regulation 361, 21 CFR. StimulEyes and its manufacturing process strictly follows this regulation. The regulation allows for only minimal manipulation of the tissue. The allograft and the eye drops cannot have chemicals or other non-human tissue added.

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 Chronic Dry Eye Syndrome, 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? 

  • Because StimulEyes is regulated under FDA 361, 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?

Can it be stocked?

  • Yes

What are the doctor’s costs?

What do profit margins look like? 

How does the doctor prescribe?

  • Each doctor needs to fill out a simple application providing the level of information for M2 Biologics to determine licensure for prescribing. The account can then be set up for the doctor or the entire practice. Orders are made by the doctor (through The McGee Group sales professional) and the product is delivered to the doctors. They then dispense from their offices. We are developing an instruction piece for doctors to give to their patients.

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.

How should my office manage filing for insurance?

  • StimulEyes does not have a specific Q code assigned to it via the Centers for Medicare and Medicaid Services (CMS), and we, with the assistance of BioLab, will apply as a separate product. Each product is approved based upon a number of criteria for the composition and type of product. In our case, it is much different than a chemical-based product that has to go through rigorous FDA testing as well. Since our product is going to be a prescribed product like Restasis and Xiidra, we cannot use the existing approved Q code issued for BioLab’s Fluid Flow product. Each product that CMS approves is by its brand name. In our case “StimulEyes”.

    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. Each of these plans must work with their Pharmacy Benefit Manager (PBM) to have the product approved as reimbursable. PBMs in the market are numerous. Some of the larger Fully Insured Carriers have their own in house PBMs. Other self-funded Employer plans to contract with PBMs to supply their formularies. 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 lengthy.

    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, it costs less for the patient. As an example, the Xiidra list price is $553.54 and most insurance plans provide a reimbursement of $200 to $276. StimulEyes with no insurance reimbursement is $249, positioning the product as at least nearly $50 less than its competitor.

    Most employers offer Healthcare Savings Accounts (HSA), 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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