Author Topic: Regener Eye is FDA Approved  (Read 346 times)

markt

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Regener Eye is FDA Approved
« on: September 26, 2019, 12:43:48 PM »
    Did a consultation for this today... for those of you who have had experience with autologous serum tears, this may be a new/better alternative:

Regener-Eyes is a sterile biologic eyedrop made of anti-inflammatory cytokines and growth factors. These 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.

How these proteins work:
- Anti-inflammatory cytokines help to reduce inflammation.
- Growth factors aid in healing, repair, and regeneration.
- Chemokines signal the immune system for healing potential.
- Hyaluronic acid helps to lubricate and protect.[/li][/list]


Regener-Eyes contains 771 naturally occurring anti-inflammatory cytokines, growth factors, and chemokines. Regener-Eyes is made utilizing our Exosomes d-MAPPSplatform technology.



https://www.totaleye.org/new-artificial-tears-developed-dry-eyes/[/url]

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6012548/


« Last Edit: September 26, 2019, 12:49:05 PM by markt »

Sharon

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Re: Regener Eye is FDA Approved
« Reply #1 on: September 26, 2019, 02:50:20 PM »
Thank you so much for this Mark!  :D
I could not use autologous serum made from my own blood.
I will definitely be looking into this!
Do you have any idea as to the price?
Sjogren's (+ RA?) positive ANA, RNP, RNP-A, APCA salivary gland swelling, dry mouth & eyes,, eyelid swelling & redness, photosensitivity, fatigue, severe joint pain, multiple sensitivities and allergic reactions 
Orencia, Restasis, Paleo Diet, Vit. D & C, Ubiquinol 200mg, Omega 3...

markt

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Re: Regener Eye is FDA Approved
« Reply #2 on: September 27, 2019, 03:53:32 AM »
« Last Edit: September 27, 2019, 03:55:09 AM by markt »

markt

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Re: Regener Eye is FDA Approved
« Reply #3 on: September 28, 2019, 04:18:21 PM »
195.00 USD per 30 Day supply.  Being new, it's not covered by some insurers.  I intend to submit a reclamation to my insurer out of medical necessity.  There is also a rebate for the first months supply to encourage trial of the medication. 

Today is my 2nd day on it and without contacts.  I'm using it a bit more than suggested to work my way out of a hole and hope to start backing off as my eyes "stabilize."

Suggested dosing is x2 daily... to get by, I am finding it to be more like 4-6 at the moment.  It definitely has a healing quality and I feel/look less inflamed.

Deb 27

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Re: Regener Eye is FDA Approved
« Reply #4 on: September 29, 2019, 10:22:59 AM »
Sounds great. Sometimes, the new drugs will come out with a co pay coupon and not be as expensive. New drugs are. notorious for being too costly. A real shame.
Sjogrens and RA,  Morphea (skin scleroderma), Hashimoto's, 
Nexium, synthroid, HRT, plaquenil,  Restasis, Maxi-tears supplement, L-glutathionne, CoQ10, folate, trintillex,  multi vitamin. lisinopril.

markt

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Re: Regener Eye is FDA Approved
« Reply #5 on: October 01, 2019, 02:34:08 PM »
Ok, yea... this stuff is great  :)

I called and spoke with their developer today.  This is covered if you are on TRICARE.  For everyone else, they do discounts on bulk buys.  This is the first time I've been out of contacts for 15 months (back when I was in the Lacripep trial).  Until that gets here, I see this (Regener Eyes as being a major part of my care plan.

I also learned that their flagship treatment is an injection therapy similar to Platelet Rich Plasma PRP with regenerative properties for this that have synovial tissue damage from various forms of Arthritis... amazing.

Starting to have a bit more hope these days.
« Last Edit: October 01, 2019, 02:36:50 PM by markt »

Sharon

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Re: Regener Eye is FDA Approved
« Reply #6 on: October 01, 2019, 03:57:21 PM »
Great to hear it's helping you Mark!
I would love to try these but until they're appoved in Europe I can't even import them where I live.  :-\
Keep us posted as to your progress.
Sjogren's (+ RA?) positive ANA, RNP, RNP-A, APCA salivary gland swelling, dry mouth & eyes,, eyelid swelling & redness, photosensitivity, fatigue, severe joint pain, multiple sensitivities and allergic reactions 
Orencia, Restasis, Paleo Diet, Vit. D & C, Ubiquinol 200mg, Omega 3...

markt

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Re: Regener Eye is FDA Approved
« Reply #7 on: October 05, 2019, 09:57:54 AM »
Doing really well... this is proving to be the most meaningful treatment for Sjogrens dry eye i have found.  This is coming from a guy whose baseline schirmers score is 4ml L/R when measured at the NIH.

I am using less of everything and my eyes feel great.  Just trying to figure out how to make this cost effective long term.

I hope folks get turned on to this; I was completely unaware.

Mark

Sharon

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Re: Regener Eye is FDA Approved
« Reply #8 on: October 05, 2019, 10:20:49 AM »
That's so good to hear Mark!
How would you compare the results you're getting to those from Laripep or autologous serum eye drops?
Sjogren's (+ RA?) positive ANA, RNP, RNP-A, APCA salivary gland swelling, dry mouth & eyes,, eyelid swelling & redness, photosensitivity, fatigue, severe joint pain, multiple sensitivities and allergic reactions 
Orencia, Restasis, Paleo Diet, Vit. D & C, Ubiquinol 200mg, Omega 3...

markt

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Re: Regener Eye is FDA Approved
« Reply #9 on: October 08, 2019, 12:52:49 PM »
Hi Sharon,

Great question.  Very few people out there at this point have had the privilege/perspective of trying all three aforementioned interventions...

- Serum tears.  For me, these had no real sustaining effect on my clinical picture. They reduced redness and had a healing quality, but it never seemed to heal and stop the inflammation.  These were also costly, inconvenient, and high maintenance as compared to just using bandage contact lenses in conjunction with lubricating drops.

- Lacripep.  I signed a Non-Disclosure concerning my experience with the Trial that I intend to honor, but I will be frank and say the day it is approved cannot come soon enough. 

- Regener Eyes. I was unaware of this treatment until my Ophthalmologist had me do a consultation for this (it's new and the Pharmaceutical Representative for the small company in FL that makes it, had just approached them about introducing this product at their practice (The process/product was only recently FDA approved as of 2018).  For me, I have to use it several times a day, but it has significantly cut down on my eye care regimen and maintenance.  It's pretty awesome and has demonstrated "healing quality" as in my sclera/conjunctiva are not red, inflamed, veiny, and pissed off due to dryness.  They feel normal and without sensation of dry spots. 

Again... different clinical pictures always benefit from medications differently.  As of last April, I made 4 ml tear in both L/R on Schirmer's testing, have MGD, SPK etc. and cannot function without contacts acting as a prosthetic tear membrane to cover my ocular surface.  I was positive for the SP-1, CA-6, and PSP anti-bodies and had a low-grade positive lip biopsy from Johns Hopkins. Also, had a series of positive RPS Inflamma Dry tests (for MMP-9 associated with auto immune inflammatory dry-eye).  I am a worse case scenario... so maybe this therapy will work even better for others.  Unfortunately, I am a frequent visitor at my Opthal and have been one of her hardest/more stubborn patients to treat.

That said, I consider this a victory... or atleatst a meaningful step in the right direction.  Hoping many more get to try this... The maker of Regener Eyes is a small lesser known company serving a fairly niche market that is flooded with products (not nearly as effective in terms of system intervention) by Allergan, Shire, and the like... so it is no wonder this product was only made known to me by a ophthalmologist.
« Last Edit: October 08, 2019, 01:09:17 PM by markt »

Sharon

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Re: Regener Eye is FDA Approved
« Reply #10 on: October 09, 2019, 09:45:16 AM »
Thanks Mark, I really appreciate all the info you're putting on this board.
I too am considered a difficult case with a Shirmer's score of 0 (ZERO) in both eyes
and an intolerance to most treatments, including serum drops, plugs and Xiidra.
Thanks to your input here I am looking into importing the Regener-Eyes drops.
Praying it works out and that they help!  :)
« Last Edit: October 09, 2019, 09:51:27 AM by Sharon »
Sjogren's (+ RA?) positive ANA, RNP, RNP-A, APCA salivary gland swelling, dry mouth & eyes,, eyelid swelling & redness, photosensitivity, fatigue, severe joint pain, multiple sensitivities and allergic reactions 
Orencia, Restasis, Paleo Diet, Vit. D & C, Ubiquinol 200mg, Omega 3...

susanep

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Re: Regener Eye is FDA Approved
« Reply #11 on: October 13, 2019, 06:54:32 AM »
I am glad this helps you Mark.  :)
I used my usual morning drops, and had to wait until I could see enough to type here. So many have such dry eyes with no real relief.

susanep
Sjogren's, Lupus, Rheumatoid Arthritis, Hypothyroid, Fibro, Sleep Apnea, Diabetes 2, Asthma, and Gerd.  (Meds I take) Omeprazole, Pilocarpine, Levothyroxine, Effexor, Cpap, Aspirin, Mobic, Prilosec,, Xanax, Restasis, Systane,Vitamin D3, Plaquenil, Gabapentin, Provigil , Advair, Nasonex, and Proventi