Sjogrens World Forums

Sjogrens Topics => Living With Sjogren's => Topic started by: markt on July 08, 2018, 03:59:15 PM

Title: Lacriprep
Post by: markt on July 08, 2018, 03:59:15 PM
https://news.virginia.edu/content/new-dry-eye-drug-first-aims-treat-cause-rather-symptoms?amp


Lacriprep is being trialed in my neighborhood specifically for Primary SS... anyone else participating or attaining via expanded access?  I am applying through the site in Ormond Beach, FL.

The scientific rigor behind this intervention is pretty compelling, check out the videos:

https://www.facebook.com/LacritinAndDryEye/videos/vb.1376039919276146/2025710027642462/?type=2&theater (https://www.facebook.com/LacritinAndDryEye/videos/vb.1376039919276146/2025710027642462/?type=2&theater)

https://www.facebook.com/LacritinAndDryEye/videos/vb.1376039919276146/2002993679914097/?type=2&theater (https://www.facebook.com/LacritinAndDryEye/videos/vb.1376039919276146/2002993679914097/?type=2&theater)
Title: Re: Lacriprep
Post by: markt on July 11, 2018, 07:13:18 AM
Added some videos that may be of interest to folks on here (links to them on the Lacriprep Facebook page are shown above).

What I still do not understand is whether or not this is considered an immunomodulatory type intervention?  Regardless, it's a ophthalmic/topical solution...
Title: Re: Lacriprep
Post by: jazzlover on July 11, 2018, 10:44:00 AM
Sounds great!
Title: Re: Lacriprep
Post by: CureSjogrensNow on July 12, 2018, 03:18:31 PM
Anyone try this yet?
Title: Re: Lacriprep
Post by: markt on July 16, 2018, 07:45:58 AM
http://www.ophthalmologytimes.com/modern-medicine-cases/novel-topical-peptide-dry-eye-tackles-underlying-cause-disease (http://www.ophthalmologytimes.com/modern-medicine-cases/novel-topical-peptide-dry-eye-tackles-underlying-cause-disease)
Title: Re: Lacriprep
Post by: markt on October 10, 2018, 11:54:41 AM
Just picked up my set of vials from my Opthalmogist's practice today. 

As part of the first visit for the trial, I did a questionnaire, signed informed consent, did some baseline testing (vision, Schimer's test, ocular staining etc.).

I will let everyone know how it goes; naturally, some things I cannot share to preserve the integrity of the ongoing trials.

- Mark

PS: I am highly surprised that so many people on here have not shown interest or shared their experiences with trials such as this.  I will do my best to fill that void.
Title: Re: Lacriprep
Post by: Sharon on October 10, 2018, 04:35:56 PM
Good luck markt, do keep us posted.
Hope you don't get the placebo.
Unfortunately I cannot get accepted into any clinical trials since I'm seronegative.
Otherwise I would in a heartbeat.
Title: Re: Lacriprep
Post by: markt on October 11, 2018, 03:46:56 AM
Hi Sharon

With this one, all that is required is diagnosis, and either positive lip biopsy report OR positive for SS-A/B antibodies.

Being SS-A/B negative myself, I am still considered qualified only because I did have the lip biopsy with focal lymphocytic sialadenitis.

.... so, talk to a site... they may well evaluate you and bring you into the study.

Title: Re: Lacriprep
Post by: Linda196 on October 11, 2018, 07:25:07 AM
I've been in a couple of trials, but they all required a non-disclosure agreement. Only one released me from that agreement at the completion of my involvement.
Title: Re: Lacriprep
Post by: Sharon on October 13, 2018, 02:41:01 PM
I refuse to do a lip biopsy after hearing some horror stories from patients who had it done
and learning it's not always accurate in any case.
In my country we also don't have many relevant clinical trials going on.
Title: Re: Lacriprep
Post by: markt on October 14, 2018, 04:37:49 PM
The biopsy turned out to be a non event for me; Hopkins literally wrote the standardized procedure for gathering and evaluating samples.  It only bothered me for several days... no loss of feeling or anything.  The reality is, that if you have any hope of being treated here in the States... you need it.  By treated, I mean with a biologic DMARD.  As you know most other treatments are in trials... and it also required for that.  So... with my back up against a wall... I did it.  There wasn't much else to lose.

In other news... this is my first full week without bandage contact lenses in a year for my dry eyes... that's all I will say about that : )
Title: Re: Lacriprep
Post by: Sharon on October 15, 2018, 09:08:30 AM
It really depends who does the lip biopsy. It can be hit or miss.
If they ever do develop a worthy treatment on label specifically for SS I may do the lip biopsy,
but right now I get the same biologicals they currently prescribe for SS through my RA diagnosis.

So glad to hear those drops may be giving you some relief!  :)
Are they preservative-free?
Will you be allowed to continue them after the study ends?
Title: Re: Lacriprep
Post by: markt on December 03, 2018, 11:50:30 AM
https://www.youtube.com/watch?v=vIifRNkm8lc

Just wanted to share this video with the crowd for awareness sake.

Tears Solutions is making a big push to gather enough data to conclude current ongoing Phase I/II trials for Lacriprep.

This means getting a few more patients into this study; or statistically "enough" of a population from which they can derive a signal of Lacriprep' s Efficacy/Safety to present to the FDA and proceed.
 
As this is considered an "additive therapy" to the FDA, Tears Solutions has the benefit of doing tailored or abbreviated versions of clinical trials for Lacriprep.

Truthfully, the sooner our patient community gets involved... they quicker we will all benefit from this medication being licensed and available.

Check out their Facebook page for the study, or contact one of the many trial sites.

https://www.facebook.com/LacritinAndDryEye/posts

http://tearsolutions.com/

If you are concerned about not meeting the study criteria; apply via the FDA Expanded Access Program.  That is exactly what it is for, and I can tell you from personal experience that you can make it work... the key is having your Opthalmogist's practice' full support.   

Regards,

Mark

 
Title: Re: Lacriprep
Post by: Sharon on December 06, 2018, 11:59:11 AM
It was good to finally get to see you Mark,
thanks for sharing!  :)
Title: Re: Lacriprep
Post by: Deb 27 on December 11, 2018, 08:26:10 AM
Perhaps there is not an interest here because people are using something that already works. Restasis works very well for me.

Big Pharma has very few "cures" for people, just treatment, that they make a ton of money on. When something comes out as a new drug, very few people can afford it. Those are the realities. They might offer coupons for a few years, then you are screwed. Those are the realities of what big Pharma.
Title: Re: Lacriprep
Post by: markt on December 11, 2018, 12:53:33 PM
I think you are making a mistake in comparing Restasis to Lacritin/Lacriprep.  Two fundamentally different approaches to treating Dry Eye.

Lacritin is a natural human protein produced by the lacrimal and to lesser degree, meibomian glands.  This protein is key to innervating neural responses that trigger our mechanism for basal tearing, and in many cases... has been shown to promote wound healing of corneal epithelia.  This approach treats a deficiency that is ubiquitous to Sjogrens Dre Eye, one that is responsible for the cascade of the inflammatory immune response causing dry eye.  It addresses the cause.

Restasis is simply a repurposed (albeit effective) immune suppressant, Cyclosporine, which can help... but isn't nearly the same, and lacks the healing properties as what was described above.

I completely understand your cynicism, but it is not well founded in this instance.  Check out the Facebook page ( and the Lacriprep Consortium Videos in particular), talk to the Clinical Coordinators involved with the ongoing trials.  This is something that I strongly believe will become a mainstay in the arsenal for folks treating Sjogrens Dry Eye.  I say this as someone who is using it at present.  For what it is worth, is anticipated to be released at a price point comparable to Restasis.
Title: Re: Lacriprep
Post by: Scottietottie on December 11, 2018, 04:11:36 PM
My understanding is that Restasis is a brand name for cyclosporine.
Title: Re: Lacriprep
Post by: Linda196 on December 12, 2018, 02:25:06 AM
Another possible reason for what is perceived as lack of interest, is the fact that the trials are limited to selected areas of the USA, which excluded a very large number of us who don't live near enough to a site to make it possible, or even in the same country.
Title: Re: Lacriprep
Post by: markt on December 12, 2018, 04:05:36 PM
Just wanted to clarify that I am a Naval Officer/Sjogrens patient with no monetary interests in Tears Solutions or development of Lacriprep; none other than being an actual Sjogrens patient, who along the rest of this community, stands to benefit from commercial licensing/release of such a first in class medication.

To further clarify; these are great people trying to help us... I can't begin to explain how accommodating, encouraging, and helpful their CMO and clinical coordinators were getting me into the trial. 

They simply forward the medication to my opthalmagist every two weeks, which is when I have a follow up assessment.  Traveling to participate is a non issue.

Tears Solutions is hardly "big pharma"; in reality they are a small Company in Charleston SC. Their CMO is a Cell Bioligist, who was part of the UVA healthcare system team (public institution no less) that studied/developed Lacritin.

UVA, a public institution, does has a stake in the drugs success. TearSolutions worked with the UVA Licensing and Ventures Group to license the patents exclusively for its company. This means UVA will benefit from royalties on any future sales of the drug.

Hopefully this answers some questions.  Again, I am only here to share my experience and encourage participation to people needing help.  Not to advertise a product.
Title: Re: Lacriprep Study
Post by: SjoDry on December 14, 2018, 05:46:29 AM
Hi SjoggieMates,

As a Sjogren's Support Group Facilitator, I received information from a nurse in Cleveland reaching out looking for dry eye patients for the Lacriprep Study.

I will post the info I received, if for some reason it is removed, you may message me for direct contact info to the nurse in Cleveland.

Happy Holidays.
SjoDry

Hello, a new Sjogren’s and Dry Eye study is looking for patients with a confirmed diagnosis of Primary Sjogren’s and who have dry eye symptoms requiring the use of lubricating drops. Eligible patients should be 18 years of age and have no other eye diseases. If you reside near the Cleveland area please give Peggy Smith a call or email her with questions pertaining to the study. There is no cost for the study however you will be compensated for your time and expenses. If you live outside the Cleveland area please call 1-800-555-5555 to see if you qualify and receive further information. Also there is a Facebook page for the study as well. https://www.facebook.com/LacritinAndDryEye/
Peggy Smith, R.N.
Abrams Eye Center
2322 East 22 St. Suite 102
Cleveland, OH 44115
216-937-2020 psmith213@att.net
Title: Re: Lacriprep
Post by: markt on December 14, 2018, 02:40:16 PM
SjoDry and others,

The trial sites and POC info for clinical coordinators is listed on the Sjogrens Syndrome Foundation website (how I found out originally) and on the Tears Solutions webpage I shared previously.  Good luck to those reaching out; it really is was easy to participate and I believe you will find this worth your time.

Mark
Title: Re: Lacriprep
Post by: rapnzl on December 27, 2018, 07:03:14 PM
Coming into this late, but wanted to thank you for sharing, Mark. How I wish I were close enough to a trial center to participate!

I have been a trial participant (for other diseases) twice, and echo Mark's encouragement to consider trial participation. (I was my ophtho's first patient on Xiidra also, and he re-evaluated me often at first, so he could send 'results' back to the company.) This is an exciting prospect in dry eye treatment, and if I were closer, I'd jump on this!

May you all find peace and comfort.
Title: Re: Lacriprep
Post by: markt on February 11, 2019, 01:02:25 PM
Hi,

It has been a while, thought I'd follow up and see if anyone has since been able to enroll and start a trial of this medication?

Also, thought I'd share this... folks are now interested in studying the mechanisms by which Lacritin works:  http://grantome.com/grant/NIH/R01-EY025980-01
Title: Re: Lacriprep
Post by: Sharon on February 11, 2019, 04:00:51 PM
Very interesting...can't wait for this to get FDA appoval.
Title: Re: Lacriprep
Post by: markt on April 23, 2019, 12:47:08 PM
Update:

TearsSolutions is nearing the end of the Phase I/II trial (which I actually participated in) and are looking to present their findings to the FDA in an effort to obtain "Orphan Drug" status for Lacripep.

The combined signal for efficacy and safety versus standard of care is hopefully persuasive enough for the FDA to grant this status and allow them to proceed with commercial licensing and sales coming out of the Phase II trial (because of the significant unmet need).

- Mark
Title: Re: Lacriprep
Post by: irish on April 23, 2019, 08:51:10 PM
I read through some of the articles and with my limited knowledge I would not call this an immunological treatment for dry eye. The article speaks of dry eye as one specific symptom with no diagnostic information.

The info they give regarding the drop sounds like it addresses inflammation as a possible cause but not in relation to autoimmune or antibody involvement. Inflammation covers some territory and it sounds like they are trying to nail this down relating to quote "simple dry eye". This could be a study with collection of some good info though so we can keep our fingers crossed.

The Restasis is the cyclosporin eye drop that addresses antibodies causing inflammation resulting in destruction of the tear gland with resultant dryness. Heavens knows how many more descriptions of inflammatory dry eye will be uncovered. Mu humble take. Irish
Title: Re: Lacriprep
Post by: markt on April 24, 2019, 10:03:10 AM
Quite the contrary,

I can tell you from personal experience, as I participated in the trial... Restasis and Lacripep are not at all comparable.  I can tell you, as I have used Restasis and Xiidra both with no meaningful effect or trends towards improvement in Ocular Staining and Schimers testing. 

https://www.facebook.com/LacritinAndDryEye/videos/2025710027642462/ (https://www.facebook.com/LacritinAndDryEye/videos/2025710027642462/). 

Watch the video... for lack of words, I was the mouse model.

Pay attention to what they state is observed regarding significant reduction of glandular infiltrate and overall recovery of lacrimal function. Restasis and Xiidra, unlike Lacripep, do nothing to promote wound healing, innervation of corneal epithelia cells, and improve the neurological deficits on our cornea that are causal to our lack of tears. 

I think folks here have something to be excited about.

V/r,

Mark
Title: Re: Lacriprep
Post by: Sharon on April 28, 2019, 04:58:17 PM
I'm happy to hear this news and look forward to having the chance to try it as soon as possible!  :)
Title: Re: Lacriprep
Post by: markt on May 07, 2019, 03:31:59 PM
NIH is opening a study to define the impact of a novel therapeutic, lacripep, on maintaining/promoting functional innervation of the cornea and lacrimal gland.

http://grantome.com/grant/NIH/R01-EY025980-01

Lacripep is the active component of lacritin, a naturally occurring glycoprotein in human tears with prosecretory and mitogenic properties.  It is concluding Phase I/II trials for PSS.

"...In our preliminary studies using this model we show lacripep not only promotes tear production but also rescues innervation of the cornea and lacrimal glands, thus restoring an essential component of ocular homeostasis. Based on these studies, we propose to determine the impact of lacripep on corneal and lacrimal gland innervation during ADDE development, as well as defining mechanisms by which lacripep maintains and/or restores innervation."

"..Thus, the goals of this proposal are to: 
Aim 1) Define the neuroregenerative potential of lacripep in the cornea and lacrimal gland during dry eye disease progression; 
Aim 2) Define the mechanisms by which lacripep achieves functional innervation of the cornea during the development of dry eye; 
and Aim 3) Determine if lacripep restores tear secretion by preferentially increasing functional parasympathetic innervation of the lacrimal gland. Using a combination of imaging, biochemical and genetic approaches, the proposed studies will considerably advance our understanding of the mechanisms by which loss of corneal innervation and secretory function occurs as well as the functional significance of denervation on disease progression."

"...With 95% of dry eye patients selectively deficient in lacritin, topical use of lacripep as a natural replacement therapy for dry eye presents a tremendous opportunity to fill an enormous void in the clinical management of these patients."
Title: Re: Lacriprep
Post by: Sharon on June 09, 2019, 05:35:22 PM
Study completion date of PhaseI/II trials is estimated at the end of this month:

https://clinicaltrials.gov/ct2/show/study/NCT03226444?show_locs=Y#locn

Fingers crossed.... 8)
Title: Re: Lacriprep
Post by: markt on June 11, 2019, 03:05:42 PM
Looking forward to this, not a day too soon.  I have been waiting since participating in the trial fall of 2018.  Check out the tearsolutions webpage and their Facebook webpage for updates.

Mark
Title: Re: Lacriprep
Post by: Sharon on June 11, 2019, 03:31:53 PM
Thanks for the info markt, hopefully this will be a game changer for us!