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 ...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.I was worried because it says it has VGEF in it which I thought might increase the Nevus. Ecstatic_Sir2450 • 2 yr. ago. Regen has 2 version: For moderate to severe dry eye, a Pro (about $150/bottle) & for mild to moderate Lite (about $80/bottle). It is a biologic eye drop that safe to use long term. 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 adjustable deep wrinkle correction device designed to restore the youthful appearance of your eyes. This innovative technology uses advanced optical technology and laser light to penetrate into the deepest layers of the skin, reducing wrinkles and revealing a smoother complexion with fewer dark circles .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.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. 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; Note: Regener-Eyes® Ophthalmic Solution, Professional and LITE Strength both have a shelf life of two (2) years when stored at room temperature. Once opened, each bottle can be stored at room temperature and used within 90 days.*. Apr 26, 2022 · Xiidra. In a phase 3 clinical trial (the last step needed before seeking FDA approval), Xiidra provided significantly more dry eye relief than the placebo eye drop. Some people reported that Xiidra started to kick in within 2 weeks of starting it. Dry eye symptoms continued to get even better over an 84-day period. 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;Mar 23, 2022 · 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 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 ... Regener-Eyes, a first in class, natural, sterile ophthalmic solution that is preservative-free and is available to ship directly to your patient. This non surgical, long lasting solution is offered in a convenient eye drop. Order Now Dosage/Info. 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.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.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.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.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 ...Dec 9, 2021 · 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 23, 2020 · Description. Developer of a biological eye drop intended to stimulate the body's own natural ability to heal, repair and regenerate. The company's product is a sterile biologic eyedrop made of anti-inflammatory cytokines and growth factors that are necessary for cell function, overall health and homeostasis, providing patients with an ... Jun 18, 2018 · The amniotic membrane (AM) has a long history of use in the treatment of various diseases of the ocular surface. It contains pluripotent cells, highly organized collagen, anti-fibrotic and anti-inflammatory cytokines, immune-modulators, growth factors, and matrix proteins. It is used to promote corneal healing in severely damaged eyes. Regener-Eyes, a first in class, natural, sterile ophthalmic solution that is preservative-free and is available to ship directly to your patient. This non surgical, long lasting solution is offered in a convenient eye drop. Order Now Dosage/Info.Regener-Eyes® | 1,076 followers on LinkedIn. The power of science, in the ease of an eye drop.™ | Regener-Eyes® is an OTC Drug To Relieve Dryness of the Eye. Apr 10, 2023 · 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 ... 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.osdosp • 1 yr. ago. dailymed.com (which pulls from the FDA database) says that Regener-Eyes is glycerin. Regenereyes.com *used* to call it a biologic, with cytokines, chemokines, growth factors, etc. And they said it was derived from placenta. 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 FORm 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.Apr 23, 2020 · Description. Developer of a biological eye drop intended to stimulate the body's own natural ability to heal, repair and regenerate. The company's product is a sterile biologic eyedrop made of anti-inflammatory cytokines and growth factors that are necessary for cell function, overall health and homeostasis, providing patients with an ... 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.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.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 ... For some patients, the biologic was transformative, promoting dramatically improved comfort, decreased staining and, in a few cases, recovery of meibomian gland structure. The two issues that limited use were the need for refrigeration and cost. Last year the company came out with Regener-Eyes LITE.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.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 ... 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 ... 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.He joined the Regener-Eyes team as of July 2019, as the VP of Sales and Business Development and assumed the COO role as of July 1st, 2020. Bob Colucci began his career with Essilor in 1989 as Director of Sales for Varilux Corporation. He was promoted to Vice President of Sales in early 1991 and had an active role over the years in the rapid ...Regener-Eyes is an FDA indicated biologic eye drop for treating the dryness of eyes. It stimulates your body’s natural healing process to heal the ocular surface of your eye. The advanced therapy eye drop contains nearly 800 specialized proteins that stimulate healing, including: What is Regener-Eyes? Regener-Eyes is a sterile, preservative-free biologic eye drop that comes in two versions, LITE (for mild ocular surface disease) and PRO (for moderate to severe ocular surface disease). Both the Pro and LITE have a shelf life of 3 years. The Pro version is required to be refrigerated while LITE may be placed at room ...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.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.Regener-Eyes is an adjustable deep wrinkle correction device designed to restore the youthful appearance of your eyes. This innovative technology uses advanced optical technology and laser light to penetrate into the deepest layers of the skin, reducing wrinkles and revealing a smoother complexion with fewer dark circles .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 EvaluationJan 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. 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 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 effectsFeb 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. 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 ... 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. 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.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; Dec 9, 2021 · 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. Register today to administer Regener-Eyes in your office. Please fill out our New Physician Registration form today. 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. 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.C. Randall Harrell, M.D. is the Founder, Chairman, and CEO of Regenerative Processing Plant, LLC. He has worked for over 30 years to become a pioneer and visionary in the field of regenerative medicine where his discoveries and patented platform technologies in the study of Type III human collagen, stem cells, and pericytes have lead to many ...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.osdosp • 1 yr. ago. dailymed.com (which pulls from the FDA database) says that Regener-Eyes is glycerin. Regenereyes.com *used* to call it a biologic, with cytokines, chemokines, growth factors, etc. And they said it was derived from placenta. 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. 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. 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.Dec 9, 2021 · 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. 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.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 ... Regener-Eyes Ophthalmic Solution is a first-in-class, natural, hypotonic ophthalmic solution to Relieve Dryness of the Eye. If you have patients not responding to current dry eye treatments, many ... For some patients, the biologic was transformative, promoting dramatically improved comfort, decreased staining and, in a few cases, recovery of meibomian gland structure. The two issues that limited use were the need for refrigeration and cost. Last year the company came out with Regener-Eyes LITE.Technology. Regener-Eyes® Ophthalmic Solution helps increase lubrication and hydration of the corneal surface. This helps to Relieve Dryness of the Eye. Regener-Eyes® Ophthalmic Solution has an excellent safety profile. Regener-Eyes® is non-steroidal. Instead, it helps to protect and relieve dryness of the eye. Each product is preservative-free. 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 ...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, 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.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® 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.Our team is the backbone of Regener-Eyes. Learn more about the people who are behind what we do! Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US.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 ...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 ... 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 ...Regener-Eyes® is a biologic eye drop made of anti-inflammatory cytokines and growth factors. These types of proteins have been shown to reduce inflammation and help stimulate the ocular surface to heal, repair, and regenerate. These proteins are necessary for cell function, overall health, and homeostasis.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. 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 ...Technology. Regener-Eyes® Ophthalmic Solution helps increase lubrication and hydration of the corneal surface. This helps to Relieve Dryness of the Eye. Regener-Eyes® Ophthalmic Solution has an excellent safety profile. Regener-Eyes® is non-steroidal. Instead, it helps to protect and relieve dryness of the eye. Each product is preservative-free.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.Regener-Eyes Dosage & Info. 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. Regener-Eyes® Ophthalmic Solution, contains a hypotonic solution ... 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 corneal 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 ...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 22, 2022 · (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… Jun 18, 2018 · The amniotic membrane (AM) has a long history of use in the treatment of various diseases of the ocular surface. It contains pluripotent cells, highly organized collagen, anti-fibrotic and anti-inflammatory cytokines, immune-modulators, growth factors, and matrix proteins. It is used to promote corneal healing in severely damaged eyes. 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 ... Regener-Eyes Ophthalmic Solution is a first-in-class, natural, hypotonic ophthalmic solution to Relieve Dryness of the Eye. If you have patients not responding to current dry eye treatments, many ... 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® 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 ...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 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.Mar 23, 2022 · 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. 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.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. Our team is the backbone of Regener-Eyes. Learn more about the people who are behind what we do! Skip to content . TAMPA, FLORIDA (877) 206 0706. HOME; ABOUT US.Regener-Eyes® is a biologic eye drop made of anti-inflammatory cytokines and growth factors. These types of proteins have been shown to reduce inflammation and help stimulate the ocular surface to heal, repair, and regenerate. These proteins are necessary for cell function, overall health, and homeostasis. He joined the Regener-Eyes team as of July 2019, as the VP of Sales and Business Development and assumed the COO role as of July 1st, 2020. Bob Colucci began his career with Essilor in 1989 as Director of Sales for Varilux Corporation. He was promoted to Vice President of Sales in early 1991 and had an active role over the years in the rapid ...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. C. Randall Harrell, M.D. is the Founder, Chairman, and CEO of Regenerative Processing Plant, LLC. He has worked for over 30 years to become a pioneer and visionary in the field of regenerative medicine where his discoveries and patented platform technologies in the study of Type III human collagen, stem cells, and pericytes have lead to many ...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. 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.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.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 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.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 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.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. 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. 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 ... 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... 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 ...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.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..