Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper; Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;Regener-Eyes, in contrast to the previously mentioned companies, markets an AF product, which is dosed 1–4 times daily for dry eye symptoms. Other companies based in South Africa, Italy, Spain, and the USA also market AME/AMEED products.Nov 17, 2020 · Regener-Eyes® LLC, a subsidiary of Regenerative Processing Plant Inc., announced that Regener-Eyes®, a first in class biologic eye drop, is giving back this holiday season by launching a campaign to help support the ongoing efforts of Prevent Blindness. Now through Jan. 15, 2021, Regener-Eyes® will donate $1 to Prevent Blindness for each purchase of either Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;Regener-Eyes is an unapproved biologic drug being marketed and sold without a biologics license in place with the FDA and it is packaged in a bottle without a preservative-free dropper. There are many reasons to be concerned about the safety of this product. Please see biologiceyedrops.org for more information.Diagnosing Scam Pharma, Part 3 - It Has a Mermaid on It - It Must Be Okay! DrB talks about Regener-Eyes past history (predecessor products) and the recent changes to their website. Gosh, it's nice to be noticed! Aug 23, 2022.Register today to administer Regener-Eyes in your office. Please fill out our New Physician Registration form today. 6. Soothe Preservative Free Lubricant Eye Drops. Bausch and Lomb's Soothe Lubricant Eye Drops are clinically proven to soothe the eyes.These revolutionary, advanced drops provide soothing comfort and long lasting lubrication, keeping eyes feeling fresh throughout the day.The original "untitled" letter to Harrell and Regener-Eyes from October said the company made claims on its website that it was a "biological product" composed of "placental-derived biomaterials ...Nov 17, 2020 · Regener-Eyes® LLC, a subsidiary of Regenerative Processing Plant Inc., announced that Regener-Eyes®, a first in class biologic eye drop, is giving back this holiday season by launching a campaign to help support the ongoing efforts of Prevent Blindness. Now through Jan. 15, 2021, Regener-Eyes® will donate $1 to Prevent Blindness for each purchase of either Register today to administer Regener-Eyes in your office. Please fill out our New Physician Registration form today. Diagnosing Scam Pharma, Part 3 - It Has a Mermaid on It - It Must Be Okay! DrB talks about Regener-Eyes past history (predecessor products) and the recent changes to their website. Gosh, it's nice to be noticed! Aug 23, 2022.Register today to administer Regener-Eyes in your office. Please fill out our New Physician Registration form today.Feb 18, 2023 · Preservative-free eye drops. This type has fewer additives and is generally recommended if you apply artificial tears more than four times a day, or if you have moderate or severe dry eyes. Preservative-free eye drops may come in single-dose vials. Artificial tears are also available as nonprescription gels and gel inserts. Oct 12, 2022 · What the FDA told Regener-Eyes, in a nutshell 1. To lawfully sell Regener-Eyes, you have to have a valid biologics license. You don’t, so you can’t. And you can’t get one till you prove it’s SAFE, pure [manufactured properly and consistently] and potent [works]. 2. To even use Regener-Eyes in clinical trials, you have to have an IND. Unlike other eye drops, Regener-Eyes is a regenerative biologic, designed to help. Regner-Eyes is trusted by many eye care professionals to bring long-lasting relief to sufferers of chronic dry eye. Ask your ECP about Regener-Eyes, and find out more about how you can harness the power of a biologic in the ease of an eye drop.Apr 25, 2023 · In late 2022, the agency sent letters to the manufacturers of Regener-Eyes ® Ophthalmic Solution and StimulEyes to inform them that their products do not comply with the Public Health Service Act ... Regener-Eyes is the only product that I’ve truly noticed a difference and got actual relief from. Prior to Regener-Eyes, I was feeling like my condition was never going to improve and unsure of what my future held as it relates to my eyes. Regener-Eyes has improved my condition so much and has allowed me to get back to normal usage of my eyes. Apr 17, 2023 · On April 10 th, the U.S. Food & Drug Administration (FDA) made an announcement to inform consumers that some manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety ... Regener-Eyes is the only product that I’ve truly noticed a difference and got actual relief from. Prior to Regener-Eyes, I was feeling like my condition was never going to improve and unsure of what my future held as it relates to my eyes. Regener-Eyes has improved my condition so much and has allowed me to get back to normal usage of my eyes.Jan 10, 2023 · Regener-Eyes® is a Safe and Effective, preservative-free option To Relieve Dryness of the Eye. Its patented technology is trademarked and formulated under the principle to “follow the science” which is the single most important standard of the company. Regener-Eyes truly is The Power of Science, in the Ease of an Eye Drop. At Regener-Eyes®, we are dedicated to the “Patient First” philosophy and have harnessed the power of social media to bring innovation to the ophthalmic industry. Our collective of influential eye care professionals, Social-Eyes™ by Regener-Eyes®, is on a mission to revolutionize the way people think about eye health by sharing expert ...Jul 19, 2023 · Regener-Eyes Professional is specifically formulated for severe cases, while Regener-Eyes Lite is intended for mild to moderate dry eye conditions. Both formulations are preservative-free, ensuring safety and minimizing side effects—a crucial consideration for individuals seeking long-term relief. Regener-Eyes LLC received its letter in October. M2 Biologics LLC received its letter in November . According to the FDA, Regener-Eyes was marketing its product, Regener-Eyes Ophthalmic Solution, as a ‘“natural, ophthalmic solution,” described as an “acellular” “biological product” that is composed of “placental-derived ...Regener-Eyes is the only product that I’ve truly noticed a difference and got actual relief from. Prior to Regener-Eyes, I was feeling like my condition was never going to improve and unsure of what my future held as it relates to my eyes. Regener-Eyes has improved my condition so much and has allowed me to get back to normal usage of my eyes. Jan 10, 2023 · Regener-Eyes® is a Safe and Effective, preservative-free option To Relieve Dryness of the Eye. Its patented technology is trademarked and formulated under the principle to “follow the science” which is the single most important standard of the company. Regener-Eyes truly is The Power of Science, in the Ease of an Eye Drop. According to DailyMed archives, from October 2021 to August 2022, Regener-Eyes was stated to contain the active ingredient glycerin and the inactive ingredients “d-MAPPS” and 0.9% Sodium Chloride USP (28,29). “d-MAPPS” does not have a Unique Ingredient Identifier (UNII) and cannot be found in any ingredient database.Contact us to learn more about Regener-Eyes today. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;October 4, 2020. Regener-Eyes Ophthalmic Solution; Regener-Eyes Ophthalmic Solution Lite. Product claims to contain human placenta. Haber’s Compounding Pharmacy 1584 Bathurst Street Toronto, ON M5P 3H3. Product recalled as it is not authorized for sale in Canada. October 30, 2020. Regener-Eyes Ophthalmic Solution.14-Jul-2022, 21:28. Regener-Eyes is an unapproved drug being deceptively marketed as though it were in compliance with FDA requirements. As a biologic drug that has undergone no clinical trials whatsoever and is not making itself accountable to regulatory oversight, it may pose risks.About. Regener-Eyes® is a first-in-class, natural, ophthalmic solution that is preservative free. Regener-Eyes® Ophthalmic Solution, Professional Strength, and LITE are used as a lubricant to prevent further irritation or to Relieve Dryness of the Eye. Technology.Jan 5, 2023 · Directions Instill 1 to 4 drops, one to four times per day in each eye, or as recommended by your eye care professional. Store at refrigerated conditions once the bottle closure is activated to the open position. Store at refrigerated conditions once the bottle closure is activated to the open position. Regener-Eyes, LLC has invested in expanding a new product for mild problems, that is formulated to be shelf-stable, Regener-Eyes® LITE - www.mydryeyes.org. PALM HARBOR, Fla., April 23, 2020 ...Oct 12, 2022 · What the FDA told Regener-Eyes, in a nutshell 1. To lawfully sell Regener-Eyes, you have to have a valid biologics license. You don’t, so you can’t. And you can’t get one till you prove it’s SAFE, pure [manufactured properly and consistently] and potent [works]. 2. To even use Regener-Eyes in clinical trials, you have to have an IND. I cannot think of any good reasons to work here. Maybe the $ if you’re in the executive suite. Cons. The business is a sham. Run fast! Shady and very sketchy business practices are rampant. “Leadership” is clueless and turnover is heavy. There is no HR, IT, and benefits are horrible and a joke. and they are very secretive.Apr 17, 2023 · On April 10 th, the U.S. Food & Drug Administration (FDA) made an announcement to inform consumers that some manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety ... Sep 29, 2022 · According to DailyMed archives, from October 2021 to August 2022, Regener-Eyes was stated to contain the active ingredient glycerin and the inactive ingredients “d-MAPPS” and 0.9% Sodium Chloride USP (28,29). “d-MAPPS” does not have a Unique Ingredient Identifier (UNII) and cannot be found in any ingredient database. Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;Autologous serum was one of the fluids used in a 1975 study testing the ability of a perfusion pump to keep chemically burned eyes moist. 1 The first study describing the benefits of serum eye drops in Sjögren’s syndrome patients with keratoconjunctivitis sicca was published in 1984. 2 Eye drops derived from a patient’s own blood have ...Yes, I sure understand that one. I am a senior with Medicare coverage which does not cover things like Regener-eyes, BlephEx, LipiFlow, TearCare, IPL, probing, etc. and all are expensive treatments. Then I did save for my old age so I can pay the freight. Healthcare is just not a priority in most countries that includes the USA.Nov 12, 2020 · Regener-Eyes Ophthalmic Solution was being imported and sold by the Calgary Trail Vision Centre in south Edmonton. But this past Monday, Health Canada announced it was recalling this unauthorized product, because it claims to contain placenta materials. Molecular mechanisms responsible for beneficial effects of Regener-Eyes®-containing eye drops in the management of DED. Regener-Eyes ® contains a large number of immunoregulatory molecules, trophic and growth factors that attenuate ongoing inflammation and may help to promote repair and regenerate the epithelial Apr 20, 2023 · The Georgia-based company's website says that the eye drops, which run $229 for a one-month supply, are currently unavailable for sale. Regener-Eyes, the other company called out by the FDA for ... A variety of factors, such as what kind of health insurance you have, will determine how much you will pay for prescription eye drops. The list price is approximately. Xiidra – $554 per box. Restasis – $586 per box. Cequa – $507 per box. Ikervis – (Available in Europe, Asia and Australia. And that is what happened to me. I lost almost two months’ time where I could have been receiving real treatment. Instead I was waiting patiently for Regener-eyes to work, and my disease was progressing insidiously, permanently damaging my eyes. I hope that my experience means something to you, and that it will serve as a lesson and as a warning.In my practice, that figure comes to between $300 and $800 per dry eye patient, depending on the severity of the dry eye.I see about 30 to 40 patients per day on the days devoted strictly to dry eye. I estimate a yearly growth of 20 percent in dry eye patient volume per year and growth of about 14 percent in dry eye clinic profitability each year. Aug 2, 2023 · Regener-Eyes Lite is used in adults to relieve burning, irritation, and discomfort caused by dry eyes. Regener-Eyes Lite may also be used for purposes not listed in this medication guide. Regener-Eyes Lite side effects May 25, 2021 · Regener-Eyes® is a sterile biologic eye drop made of anti-inflammatory cytokines and growth factors. With over millions of treatments, Regener-Eyes® has a great safety profile due to it being ... The Georgia-based company's website says that the eye drops, which run $229 for a one-month supply, are currently unavailable for sale. Regener-Eyes, the other company called out by the FDA for ...May 25, 2021 · Regener-Eyes® is a sterile biologic eye drop made of anti-inflammatory cytokines and growth factors. With over millions of treatments, Regener-Eyes® has a great safety profile due to it being ... About Regener-Eyes: Regener-Eyes® is a first in class, natural, biologic ophthalmic solution that is preservative free. Regener-Eyes has been used safely in over one million treatments.Sep 19, 2022 · Diagnosing Scam Pharma, Part 3 - It Has a Mermaid on It - It Must Be Okay! DrB talks about Regener-Eyes past history (predecessor products) and the recent changes to their website. Gosh, it's nice to be noticed! Aug 23, 2022. Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper; Unlike other eye drops, Regener-Eyes is a regenerative biologic, designed to help. Regner-Eyes is trusted by many eye care professionals to bring long-lasting relief to sufferers of chronic dry eye. Ask your ECP about Regener-Eyes, and find out more about how you can harness the power of a biologic in the ease of an eye drop.Adding topical steroids and doxycycline for 1 to 2 months to reduce matrix metallopeptidase 9–related surface inflammation can be helpful. Amniotic membranes and long-term use of bandage contact lenses are another approach. Biologics such as Regener-Eyes ophthalmic solution (Regener-Eyes) and autologous serum drops are also used to treat RCE. Regener-Eyes started from humble beginnings. Learn more about us and our story today, and contact us to find relief in the ease of an eye drop.Oct 30, 2020 · OTTAWA, ON, Oct. 30, 2020 /CNW/ -Product: Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution Lite (biologic eye drops)Issue: Th... Oct 5, 2021 · 14-Jul-2022, 21:28. Regener-Eyes is an unapproved drug being deceptively marketed as though it were in compliance with FDA requirements. As a biologic drug that has undergone no clinical trials whatsoever and is not making itself accountable to regulatory oversight, it may pose risks. Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;Diagnosing Scam Pharma, Part 3 - It Has a Mermaid on It - It Must Be Okay! DrB talks about Regener-Eyes past history (predecessor products) and the recent changes to their website. Gosh, it's nice to be noticed! Aug 23, 2022.Aug 16, 2022 · The drop is called Regener-Eyes and it is a groundbreaking for dry eye treatment! What is Regener-Eyes? Regener-Eyes is a preservative free eye drop that comes in two versions, LITE (mild ocular surface disease) and PROFESSIONAL (moderate to severe ocular surface disease). The Pro version is required to be refrigerated while LITE can be stored The original "untitled" letter to Harrell and Regener-Eyes from October said the company made claims on its website that it was a "biological product" composed of "placental-derived biomaterials ...The Georgia-based company's website says that the eye drops, which run $229 for a one-month supply, are currently unavailable for sale. Regener-Eyes, the other company called out by the FDA for ...Contact us to learn more about Regener-Eyes today. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;And that is what happened to me. I lost almost two months’ time where I could have been receiving real treatment. Instead I was waiting patiently for Regener-eyes to work, and my disease was progressing insidiously, permanently damaging my eyes. I hope that my experience means something to you, and that it will serve as a lesson and as a warning.Molecular mechanisms responsible for beneficial effects of Regener-Eyes®-containing eye drops in the management of DED. Regener-Eyes ® contains a large number of immunoregulatory molecules, trophic and growth factors that attenuate ongoing inflammation and may help to promote repair and regenerate the epithelial Regener-Eyes, LLC . 34176 US Hwy 19 N . Palm Harbor, FL 34684 . Dear Dr. Harrel: The Office of Compliance and Biologics Quality in the Center for Biologics Evaluation Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper; About Regener-Eyes® is an OTC Drug that is preservative free. Regener-Eyes® Ophthalmic Solution, Professional Strength, and LITE are used as a lubricant to prevent further irritation or To Relieve Dryness of the Eye. Technology Regener-Eyes® Ophthalmic Solution helps increase lubrication and hydration of the cornealRegener-Eyes (Regener-Eyes) This is a sterile, preservative-free option to relieve dryness of the eye that is nonsteroidal and derived from amniotic fluid. 23 According to the company, use of Regener-Eyes assists the tear film layer by increasing lubrication and hydration, which promotes homeostasis of the corneal surface and helps slow down ...Jan 26, 2021 · Regener-Eyes® launched the Prevent Blindness Holiday Campaign within their group of Optometrists and Ophthalmologists that currently script and/or stock Regener-Eyes® eye drops. Mar 15, 2023 · Regener-Eyes (Regener-Eyes) This is a sterile, preservative-free option to relieve dryness of the eye that is nonsteroidal and derived from amniotic fluid. 23 According to the company, use of Regener-Eyes assists the tear film layer by increasing lubrication and hydration, which promotes homeostasis of the corneal surface and helps slow down the cycle of dry eye perpetuation. Apr 17, 2023 · On April 10 th, the U.S. Food & Drug Administration (FDA) made an announcement to inform consumers that some manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety ... Aug 8, 2023 · There is only one anti-aging ingredient in the product. No substantial evidence proves its effectiveness and safety. The websites offering Regenere contain many typos which is a bad sign in terms of the product’s quality. Many feedbacks say it doesn’t really work and there are complaints because of the free trial’s automatic shipment program. According to DailyMed archives, from October 2021 to August 2022, Regener-Eyes was stated to contain the active ingredient glycerin and the inactive ingredients “d-MAPPS” and 0.9% Sodium Chloride USP (28,29). “d-MAPPS” does not have a Unique Ingredient Identifier (UNII) and cannot be found in any ingredient database.Aug 16, 2022 · The drop is called Regener-Eyes and it is a groundbreaking for dry eye treatment! What is Regener-Eyes? Regener-Eyes is a preservative free eye drop that comes in two versions, LITE (mild ocular surface disease) and PROFESSIONAL (moderate to severe ocular surface disease). The Pro version is required to be refrigerated while LITE can be stored Jan 10, 2023 · Regener-Eyes® is a Safe and Effective, preservative-free option To Relieve Dryness of the Eye. Its patented technology is trademarked and formulated under the principle to “follow the science” which is the single most important standard of the company. Regener-Eyes truly is The Power of Science, in the Ease of an Eye Drop. Aug 8, 2023 · There is only one anti-aging ingredient in the product. No substantial evidence proves its effectiveness and safety. The websites offering Regenere contain many typos which is a bad sign in terms of the product’s quality. Many feedbacks say it doesn’t really work and there are complaints because of the free trial’s automatic shipment program. Eye drops made from amniotic fluid. According to the FDA’s Public Safety Notification issued on April 10, 2023, Regener-Eyes and StimulEyes are both made from amniotic fluid. Note: When we first launched this site, we used the term biologic (or biological) eye drops to refer to any eye drops claiming to be derived from human reproductive ...Apr 23, 2020 · Regener-Eyes, LLC has invested in expanding a new product for mild problems, that is formulated to be shelf-stable, Regener-Eyes® LITE - www.mydryeyes.org. PALM HARBOR, Fla., April 23, 2020 ... Register today to administer Regener-Eyes in your office. Please fill out our New Physician Registration form today.
Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;. Spider man r34
Register today to administer Regener-Eyes in your office. Please fill out our New Physician Registration form today. Contact Regener-Eyes to learn more about our eye drop and find immediate relief today. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Due to the complexity of Regener-Eyes eye drops, DryEye Rescue has setup an online portal for our customers to order and talk directly with the Regener-Eyes specialist. Once you submit the form, a product specialist will contact you to place your order and answer any questions you might have.“Regener-Eyes is a fantastic addition to our treatment offerings for patients along the entire severity continuum. Regener-Eyes® consistently performs very well, helping re-establish a healthy ocular surface and provides my patients reliable subjective improvement.”-Ahmad M. Fahmy, OD, FAAO, DIPL., ABORegener-Eyes (Regener-Eyes) This is a sterile, preservative-free option to relieve dryness of the eye that is nonsteroidal and derived from amniotic fluid. 23 According to the company, use of Regener-Eyes assists the tear film layer by increasing lubrication and hydration, which promotes homeostasis of the corneal surface and helps slow down ...Aug 16, 2022 · The drop is called Regener-Eyes and it is a groundbreaking for dry eye treatment! What is Regener-Eyes? Regener-Eyes is a preservative free eye drop that comes in two versions, LITE (mild ocular surface disease) and PROFESSIONAL (moderate to severe ocular surface disease). The Pro version is required to be refrigerated while LITE can be stored Contact us to learn more about Regener-Eyes today. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper; Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US. Peer-Reviewed Scientific White Paper;OTTAWA, ON, Oct. 30, 2020 /CNW/ -Product: Regener-Eyes Ophthalmic Solution and Regener-Eyes Ophthalmic Solution Lite (biologic eye drops)Issue: Th...Jan 13, 2022 · Finally, Regener-Eyes (Regener-Eyes; Palm Beach, FL, USA) is an AF eyedrop that can be used one to four times daily. A major advantage of AME and AF eyedrops is to avoid mechanical placement of AM tissue (as discussed in the next section) and its associated complications. Regener-Eyes ® is an OTC Drug To Relieve Dryness of the Eye. It is available in Professional and LITE Strengths. The Power of Science, in the Ease of an Eye Drop. ™ Step 1: Register Please complete the online Eye Care Professional (ECP) registration form below. (If you have already registered, please go straight to Step 2) Registration FORmJan 10, 2023 · Regener-Eyes® is a Safe and Effective, preservative-free option To Relieve Dryness of the Eye. Its patented technology is trademarked and formulated under the principle to “follow the science” which is the single most important standard of the company. Regener-Eyes truly is The Power of Science, in the Ease of an Eye Drop. Regener-Eyes Lite is used in adults to relieve burning, irritation, and discomfort caused by dry eyes. Regener-Eyes Lite may also be used for purposes not listed in this medication guide. Regener-Eyes Lite side effectsNov 12, 2020 · Regener-Eyes Ophthalmic Solution was being imported and sold by the Calgary Trail Vision Centre in south Edmonton. But this past Monday, Health Canada announced it was recalling this unauthorized product, because it claims to contain placenta materials. Adding topical steroids and doxycycline for 1 to 2 months to reduce matrix metallopeptidase 9–related surface inflammation can be helpful. Amniotic membranes and long-term use of bandage contact lenses are another approach. Biologics such as Regener-Eyes ophthalmic solution (Regener-Eyes) and autologous serum drops are also used to treat RCE. (Which is what Regener-Eyes is currently claiming to be.) The FDA approves prescription drugs, including biological products. The FDA has not approved Regener-Eyes, and Regener-Eyes has never applied for approval. In fact, the FDA told Regener-Eyes so very clearly in their letter on October 5. Oh, and by the way…Biologic Eye Drops. As a general matter, amniotic fluid eyedrops used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act and are subject to premarket review and approval requirements. There are currently no FDA-approved ... .