Delivery Method: Via Email Product: Drugs Recipient:
Recipient Name
Tom Freyne
Scope Health Inc
79 Madison Ave, Fl 8
New York, NY 10016
United States
hello@optase.com Issuing Office: Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
July 9, 2025
RE: 695085
Dear Mr. Freyne:
This letter is to advise you that on August 28, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address optase.com where your ophthalmic drug products are available for purchase in the United States without a prescription.
Based on our review, your MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, HYLO Night Eye Ointment, Tea Tree Oil Eyelid Wipes, Tea Tree Oil Eyelid Gel, and Protect Eyelid Cleansing Spray drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, your Dry Eye Intense Drops (multi-use bottle) product is misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), and your Allegro Eye Drops, MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), and HYLO Night Eye Ointment products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.
Unapproved New Drug and Misbranded Drug Violations
MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, HYLO Night Eye Ointment, Tea Tree Oil Eyelid Wipes, Tea Tree Oil Eyelid Gel, and Protect Eyelid Cleansing Spray are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.
Examples of claims from the products’ labeling, including on your website listed above, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
MGD Advanced Dry Eye Drops
“OPTASE® MGD Advanced Drops provide a preservative free combination of ingredients designed to relieve dry eye symptoms . . . An Advanced Lipid-based drop for Evaporative Dry Eye & MGD Symptoms . . .” [from your product website at https://optase.com/product/mgd-advanced-dry-eye/]
Dry Eye Intense Drops (multi-use bottle and single dose)
“The special formulation of OPTASE® Intense provides comfort from moderate to severe dry eye including dry eye post operatively. . . .” [from your product websites at https://optase.com/product/dry-eye-intense-drops/ and https://optase.com/product/dryeye-intense-drops-sdu/]
Allegro Eye Drops
“Optase® Allegro Eye Drops is a preservative free lubricant that acts as a first line of defense to stop environmental irritants in their tracks . . . by creating a more protective tear film and strengthening the ocular mucosa. This unique formulation . . . creates a water rich shield to protect epithelial cells from environmental irritants” [from the product website at https://optase.com/product/allegro-eye-drops/]
HYLO Night Eye Ointment
“How It Works . . . OPTASE® HYLO Night™ relieves night-time symptoms of burning, sore, dry eyes by forming a comfortable long-lasting protective film on the eyes. . . .” [from your product website at https://optase.com/product/hylo-night/]
Tea Tree Oil Eyelid Wipes
“Cleaning your eyelids daily will help remove debris, bacteria and oils that can often lead to Blepharitis, MGD or Dry Eye symptoms. . . . FORMULATED WITH NATURAL INGREDIENTS FOR SENSITIVE SKIN . . . Anti-Inflammatory Tea Tree Leaf Oil . . .” [from your product website https://optase.com/product/tea-tree-oil-wipes/]
Tea Tree Oil Eyelid Gel
“OPTASE® Tea Tree Oil Gel . . . can be used as part of the recommended management regimen for Blepharitis . . . GENTLE FORMULA ENRICHED WITH NATURAL INGREDIENTS . . . Anti-Inflammatory Tea Tree Leaf Oil . . .” [from your product website https://optase.com/product/tea-tree-oil-gel/]
Multiple products
“About Meibomian Gland Dysfunction (MGD) . . . MGD is a chronic condition which occurs when the glands in the eyelids don’t produce enough oil, or the oil that is produced is of poor quality. . . . How to manage MGD . . . Cleanse . . . maintain clean eyelids and lashes to ensure there is nothing that can block oils from reaching the surface of the eye. . . . Hydrate . . . If you suffer from severe MGD you may require an eye drop that can supplement the oily layer in your tear film to reduce tear evaporation. . . . Addressing the root cause of MGD . . . can also lead to a reduction of symptoms in related conditions such as Dry Eye Disease (DED) and Blepharitis. . . . Products To Relieve Symptoms . . . MGD Advanced Dry Eye Drops . . . Dry Eye Intense Drops . . . Single Dose Dry Eye Intense Drops . . . HYLO Night Eye Ointment” [from your website at https://optase.com/about-mgd/]
“About Blepharitis . . . What is Blepharitis . . . There are two main types of Blepharitis: . . . Anterior Blepharitis . . . This is where the inflammation affects the skin around the base of your eyelashes . . . Posterior Blepharitis . . . This is where the inflammation affects your eyelid glands. Meibomian Gland Dysfunction (MGD) can occur when the eyelid glands become clogged. . . . How to manage Blepharitis . . . Daily lid hygiene is key to the management of Blepharitis and other conditions of the eye such as Meibomian Gland Dysfunction (MGD) and Styes. . . . Products To Relieve Symptoms . . . Tea Tree Oil Eyelid Wipes . . . Tea Tree Oil Eyelid Gel . . . Protect Eyelid Cleansing Spray” [from your website at https://optase.com/about-blepharitis/]
Unapproved New Drug Violations
Based on the above labeling evidence, your MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, HYLO Night Eye Ointment, Tea Tree Oil Eyelid Wipes, Tea Tree Oil Eyelid Gel, and Protect Eyelid Cleansing Spray products are intended for use as topical ophthalmic drug products. As described below, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. Your above-referenced topical ophthalmic drug products are not generally recognized as safe and effective (GRASE) for their above referenced uses1 and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from the FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for any of the products identified above.
In addition, under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application—commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription ophthalmic drug products, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, Over-the-Counter Monograph M018, Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).2 However, your nonprescription ophthalmic drug products MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, and HYLO Night Eye Ointment do not conform to the conditions specified in M018 for the reasons described below, and thus cannot be legally marketed under section 505G.
Ophthalmic Demulcent Products
Your MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), and Allegro Eye Drops are demulcent products formulated with several active ingredients that are not permitted for OTC monograph ophthalmic demulcent drug products. Specifically, according to your products’ labeling, your MGD Advanced Dry Eye Drops product is formulated with the active ingredients glycerin, sacha inchi seed oil, trehalose, and sodium hyaluronate. Your Dry Eye Intense Drops products are formulated with glycerin and sodium hyaluronate and your Allegro Eye Drops product is formulated with hydroxyethyl cellulose and Ectoin®.
However, sacha inchi seed oil, trehalose, sodium hyaluronate, and Ectoin® are not active ingredients permitted for ophthalmic demulcent drug products under M018.12. We note that, although you identify these ingredients as inactive ingredients on the product label, statements on your website show that they are active ingredients in their respective products because they are intended to furnish pharmacological activity for the treatment of a disease or condition.3 Examples of these statements include, “Contains Sacha inchi seed oil, Trehalose and Hyaluronic Acid which combine to strengthen and replenish your tear film, and protect your eyes. . . .” (MGD Advanced Dry Eye Drops); “INACTIVE INGREDIENT: Sodium hyaluronate . . . Binds to eye surface with comfortable, soothing properties” (Dry Eye Intense Drops); and “This unique formulation includes . . . Ectoin® which creates a water rich shield to protect epithelial cells from environmental irritants . . .” (Allegro Eye Drops). Thus, these ingredients are active ingredients and, because they are not active ingredients permitted under M018.12, the MGD Advanced Dry Eye Drops, Dry Eye Intense Drops, and Allegro Eye Drops products do not conform with the conditions for lawful marketing of an OTC ophthalmic demulcent product as set forth in M018.
Ophthalmic Emollient Products
Your HYLO Night Eye Ointment product is an emollient product formulated with the active ingredient vitamin A. However, vitamin A is not an active ingredient that is permitted for ophthalmic emollient drug products under M018.14. We note that, although you identify this ingredient as an inactive ingredient on the product label, statements on your website show that it is an active ingredient in the product because it is intended to furnish pharmacological activity for the treatment of a disease or condition.4 For example, your product website states, “OPTASE® HYLO Night™ is a soft and consistent ointment, containing Vitamin A . . . to help improve the tear film and protect the surface of the eye.” Thus, this is an active ingredient that is not permitted under M018.14, therefore your HYLO Night Eye Ointment product does not conform with the conditions for lawful marketing of an OTC ophthalmic emollient product as set forth in M018.
For the above reasons, your above-referenced products MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, HYLO Night Eye Ointment, Tea Tree Oil Eyelid Wipes, Tea Tree Oil Eyelid Gel, and Protect Eyelid Cleansing Spray are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
Misbranded Drug Violations
Further, your Dry Eye Intense Drops (multi-use bottle) product is misbranded under section 502(f)(2) of the FD&C Act because its labeling does not “[bear]…such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users…”. Here, the warning described in M018.60, “If solution changes color or becomes cloudy, do not use”, is required for ophthalmic demulcent drug products, such as your Dry Eye Intense Drops (multi-use bottle) product, to be legally marketed under section 505G of the FD&C Act. This monograph warning also falls within the scope of the warnings described in section 502(f)(2) of the FD&C Act. Thus, omission of this monograph warning from the product labeling renders the product misbranded under section 502(f)(2).
Additionally, your Allegro Eye Drops, MGD Advanced Dry Eye Drops, Dry Eye Intense Drops, (multi-use bottle and single dose), and HYLO Night Eye Ointment products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section (as described above) and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “695085” in the subject line of your email.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
_____________________________
1 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that your above-referenced topical ophthalmic drug products are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.
2 M018 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000023, available at FDA’s website OTC Monographs @ FDA, https://dps.fda.gov/omuf.
3 See 21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”
4 Id.
