Dosage and FAQs | Regener-Eyes

Dosage

The product is self administered and can be used daily.

The recommended dosage for Regener-Eyes® Professional Strength and Regener-Eyes® LITE:

1 – 4 drops per eye / day depending on severity and physician’s recommendation

FAQ’s

Q. What is the shelf life?

A. Regener-Eyes has a 3-year shelf life from manufacturing date (if unopened and refrigerated). A bottle should not be opened until ready to use; once opened, it will continue to need to be refrigerated and will remain good for 90 days.

Q. What is the difference between Regener-Eyes® LITE and Regener-Eyes® Professional Strength?
A. Regener-Eyes® LITE is a result of re-formulating our patented platform technology to develop a shelf-stable product at room temperature. As a result, it is not as strong as Regener-Eyes® Professional Strength. Regener-Eyes LITE is perfect for your mild to moderate patients.

Regener-Eyes® LITE and Regener-Eyes® Professional Strength are made from the same sterile platform technology and 771 bio-engineered proteins (cytokines, growth factors, chemokines, and hyaluronic acid). Both products are sterile, acellular, and have a 3-year shelf life from manufacturing without preservatives.

Product Recap
Regener-Eyes® LITE is non-refrigerated and formulated for mild to moderate patients.
Regener-Eyes® Professional Strength is refrigerated and formulated for severe patients.
The formulation and production of both products are manufactured under a proprietary patented process

Q. Contraindications?
A. There are currently no contraindications

Q. Biologics vs. Pharmaceuticals what is the difference?

A. Pharmaceuticals are small molecules that usually only affect one pathway and some with unknown mechanisms of action. Usually high % of side effects (or just negative effects!)

Biologics are natural (if processed correctly) and allows multiple pathways to be effective that address multiple mechanisms of action. For example, anti-inflammatory cytokines have been shown to decrease chronic inflammation and growth factors may help stimulate the regeneration of cells.

Q. Is Regener-Eyes® LITE and Regener-Eyes® Professional Strength safe?
A. Regener-Eyes has a great safety profile and has had 0 reported adverse events due to the following.

Regener-Eyes is sterile SAL 10^-6
Regener-Eyes is acellular, meaning all cells, DNA, and debris is taken out of the product, leaving pure proteins.

Q. What type of results do you get?
A. Please see our clinical data

Q. How long until l will see results?

A. It depends on age and severity. We suggest 3-6 months of use. However, most patients start to see some relief within the first 6 weeks.

Q. What is it made of/where does it come from?

A. It is a bioengineered protein-based fluid, extracted from human placental-derived biomaterials. It is obtained from healthy, living donors with informed consent and full screening following, and exceeding, all FDA and AATB guidelines, collected via an AATB certified 501c3. All materials are from healthy pregnancies at the time of a scheduled C-sections; no ethical concerns.

Q. Regener-Eyes is a sterile product, what is the FDA’s position on risk of using a non-sterile product?

A. Manufacturers should have a keen awareness of the public health implication of distributing a non-sterile drug purporting to be sterile. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life-threatening. Once again, Regener-Eyes is sterile.

Q. What is the FDA’s requirements for products that are unsterile (aseptic) vs sterile?

A. The sponsor should state the Sterility Assurance Level (SAL) of 10^-6 for products labeled as sterile unless the device is intended for contact with intact skin. FDA recommends a SAL of 10^-3 for products intended only for contact with intact skin.

SAL 10^-6 is one chance in a million of causing an infection vs. SAL 10^-3 which is one in a thousand chance of causing an infection. If a product has only a SAL 10^-3 instead of 10^-6, there would be 1000 times greater risk of causing an infection.

Q. Can Regener-Eyes be used with a sclera lens?

A. It is up to your ECP, however, many physicians and patients have found success with using Regener-Eyes and their sclera lens together. Some patients with their doctors instruction have put Regener-Eyes in their lens to have a better dwell time for the proteins in Regener-Eyes. If they are able to use other wetting agents with their sclera lens, they can use Regener-Eyes to promote improvement for the corneal surface. There is not a contraindication with using Regener-Eyes and sclera lenses together.