The Sjögren’s Foundation remains dedicated to the safety of Sjögren’s patients and providing you with the information you need to make important health decisions.
Patients with Sjögren's have received several doctor recommendations for Regener-Eyes® products.
Last year, the Sjögren’s Foundation informed you of the Food and Drug Administration's public safety notification about the use of amniotic fluid in certain brands of eyedrops marketed to treat, mitigate, or cure disease or conditions such as dry eye disease. Presently, there are no FDA-approved amniotic eyedrops indicated for the treatment, mitigation, or cure of eye diseases.
Regener-Eyes®, which currently makes two ophthalmologic drugs— Regener-Eyes® PRO and Regener-Eyes® LITE— was listed as a brand containing amniotic fluid. They have since then taken Regener-Eyes® Ophthalmic Solution containing amniotic fluid off the market.
On August 16th, 2024, Regener-Eyes® (under the company Regenerative Processing Plant, LLC) received a warning letter from the Food and Drug Administration (FDA) stating significant safety and mislabeling concerns about its currently manufactured products. The agency also stated that the company's Regener-Eyes® PRO and LITE products were unapproved new drugs because they make claims about treating dry eyes. The FDA inspection occurred in late June 2023, where the company was cited for several violations. Despite the company taking corrective actions between July 2023 and February 2024, they are still not compliant under FDA regulation.
The violations cited by the FDA in its warning letter to Regener-Eyes® are briefly described below.
Unapproved New Drug and Misbranding violations
Regener-Eyes® products are indicated for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, including claims to “relieve dryness of the eye” and “a new therapeutic agent to relieve dryness of the eye for tear hyperosmolarity-induced pathological changes in the eyes of patients suffering from dry eye discomfort.” Regener-Eyes® currently has no FDA-approved new drug applications.
The eyedrops also fail to meet certain conditions for them to be considered an over-the-counter (OTC) drug, meaning the company must be approved for a new drug application prior to the treatment being marketed. Regener-Eyes® products use tonicity solution sodium chloride as an ophthalmic demulcent (eye lubricant or solution used to relieve dryness and irritation), which is not an ingredient that is permitted to be used in an OTC drug. There are also no FDA-required warning labels for ophthalmic demulcents on Regener-Eyes® products. Therefore, Regener-Eyes® products do not meet requirements to legally be marketed as an OTC drug and have not been found to be generally recognized as safe and effective (GRASE).
The FDA also states that the representation of Regener-Eyes® products as “in full compliance with the FDA” is false as they are not in compliance with several statutory requirements from the FDA.
CGMP (common good manufacturing practices)
The manufacturing company used to produce Regener-Eyes® PRO and Regener-Eyes® LITE is not adequately validated in aseptic processes that ensure products can be made in the absence of bacteria. The company failed to establish and follow appropriate written procedures as well as monitoring and testing protocols designed to prevent contamination of drug products. Drug components, such as sodium chloride, were also not tested to identify the quality and composition of the components prior to use in their eyedrop products. Although the company addressed several of these actions by voluntarily stopping manufacturing of these products, they did not remove prior lots from the market which are still within the labeled expiration date. The FDA also acknowledged a lack of supporting data for their environmental monitoring, identity of components testing, and stability testing of the two-year expiration date. Furthermore, these eyedrop products also contain glycerin that can produce diethylene glycol (DEG) or ethylene glycol. DEG and ethylene glycol are considered to be lethal poisons above safe limits. Due to a lack of identity testing of components in their eyedrops, this is a major safety concern.
Contamination Risks
The packaging of Regener-Eyes® PRO and Regener-Eyes® LITE did not prevent backflow and are labeled preservative-free. Since the products do not contain a substance to inhibit the growth of organisms, the container did not provide adequate protection to minimize contamination during use. Given the CGMP violations and insufficient packaging, the FDA stated that the products were of significant safety concern from a public health perspective. The eye lacks some of the body’s natural defenses and is at high risk of harm to users of potentially contaminated products. For patients with Sjögren’s and other autoimmune diseases, this would be a severe concern and risk for infection.
Products potentially containing amniotic fluid
As mentioned above, Regener-Eyes® was previously warned about its products containing amniotic fluid. After a notification letter from the FDA in late 2022, the company said that it stopped using amniotic fluid in their eyedrops after June 2021. However, the FDA cites that lack of batch records and identity testing along with shipments of amniotic fluid to the company after June 2021, raises concerns that amniotic fluid may still be present in their products manufactured after June 2021. Regener-Eyes® would require a special license for manufacturing biologics—products derived from human blood and plasma such as amniotic fluid—, which it does not currently have. The FDA also has safety concerns about the use of amniotic fluid eyedrops in general. You can read the FDA’s Public Safety Notice on Amniotic Fluid Eyedrops here.
While there have been no reported incidences of contamination and no product recalls on these products, the Sjögren’s Foundation does not recommend the use of Regener-Eyes® products until they are fully FDA compliant.
The Sjögren’s Foundation remains dedicated to the safety of Sjögren’s patients and providing you with the information you need to make important health decisions.
Patients with Sjögren's have received several doctor recommendations for Regener-Eyes® products.
Last year, the Sjögren’s Foundation informed you of the Food and Drug Administration's public safety notification about the use of amniotic fluid in certain brands of eyedrops marketed to treat, mitigate, or cure disease or conditions such as dry eye disease. Presently, there are no FDA-approved amniotic eyedrops indicated for the treatment, mitigation, or cure of eye diseases.
Regener-Eyes®, which currently makes two ophthalmologic drugs— Regener-Eyes® PRO and Regener-Eyes® LITE— was listed as a brand containing amniotic fluid. They have since then taken Regener-Eyes® Ophthalmic Solution containing amniotic fluid off the market.
On August 16th, 2024, Regener-Eyes® (under the company Regenerative Processing Plant, LLC) received a warning letter from the Food and Drug Administration (FDA) stating significant safety and mislabeling concerns about its currently manufactured products. The agency also stated that the company's Regener-Eyes® PRO and LITE products were unapproved new drugs because they make claims about treating dry eyes. The FDA inspection occurred in late June 2023, where the company was cited for several violations. Despite the company taking corrective actions between July 2023 and February 2024, they are still not compliant under FDA regulation.
The violations cited by the FDA in its warning letter to Regener-Eyes® are briefly described below.
Unapproved New Drug and Misbranding violations
Regener-Eyes® products are indicated for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, including claims to “relieve dryness of the eye” and “a new therapeutic agent to relieve dryness of the eye for tear hyperosmolarity-induced pathological changes in the eyes of patients suffering from dry eye discomfort.” Regener-Eyes® currently has no FDA-approved new drug applications.
The eyedrops also fail to meet certain conditions for them to be considered an over-the-counter (OTC) drug, meaning the company must be approved for a new drug application prior to the treatment being marketed. Regener-Eyes® products use tonicity solution sodium chloride as an ophthalmic demulcent (eye lubricant or solution used to relieve dryness and irritation), which is not an ingredient that is permitted to be used in an OTC drug. There are also no FDA-required warning labels for ophthalmic demulcents on Regener-Eyes® products. Therefore, Regener-Eyes® products do not meet requirements to legally be marketed as an OTC drug and have not been found to be generally recognized as safe and effective (GRASE).
The FDA also states that the representation of Regener-Eyes® products as “in full compliance with the FDA” is false as they are not in compliance with several statutory requirements from the FDA.
CGMP (common good manufacturing practices)
The manufacturing company used to produce Regener-Eyes® PRO and Regener-Eyes® LITE is not adequately validated in aseptic processes that ensure products can be made in the absence of bacteria. The company failed to establish and follow appropriate written procedures as well as monitoring and testing protocols designed to prevent contamination of drug products. Drug components, such as sodium chloride, were also not tested to identify the quality and composition of the components prior to use in their eyedrop products. Although the company addressed several of these actions by voluntarily stopping manufacturing of these products, they did not remove prior lots from the market which are still within the labeled expiration date. The FDA also acknowledged a lack of supporting data for their environmental monitoring, identity of components testing, and stability testing of the two-year expiration date. Furthermore, these eyedrop products also contain glycerin that can produce diethylene glycol (DEG) or ethylene glycol. DEG and ethylene glycol are considered to be lethal poisons above safe limits. Due to a lack of identity testing of components in their eyedrops, this is a major safety concern.
Contamination Risks
The packaging of Regener-Eyes® PRO and Regener-Eyes® LITE did not prevent backflow and are labeled preservative-free. Since the products do not contain a substance to inhibit the growth of organisms, the container did not provide adequate protection to minimize contamination during use. Given the CGMP violations and insufficient packaging, the FDA stated that the products were of significant safety concern from a public health perspective. The eye lacks some of the body’s natural defenses and is at high risk of harm to users of potentially contaminated products. For patients with Sjögren’s and other autoimmune diseases, this would be a severe concern and risk for infection.
Products potentially containing amniotic fluid
As mentioned above, Regener-Eyes® was previously warned about its products containing amniotic fluid. After a notification letter from the FDA in late 2022, the company said that it stopped using amniotic fluid in their eyedrops after June 2021. However, the FDA cites that lack of batch records and identity testing along with shipments of amniotic fluid to the company after June 2021, raises concerns that amniotic fluid may still be present in their products manufactured after June 2021. Regener-Eyes® would require a special license for manufacturing biologics—products derived from human blood and plasma such as amniotic fluid—, which it does not currently have. The FDA also has safety concerns about the use of amniotic fluid eyedrops in general. You can read the FDA’s Public Safety Notice on Amniotic Fluid Eyedrops here.
While there have been no reported incidences of contamination and no product recalls on these products, the Sjögren’s Foundation does not recommend the use of Regener-Eyes® products until they are fully FDA compliant.