Announcement

**Rebecca Petris** · 01-Mar-2005, 10:56

Hi Grandmajane! Welcome to Dry Eye Talk!

Wow, cautery AND tarrsorhaphy... you've been through a lot with this.

I really appreciate your post... this is exactly the kind of thing we're hoping for, to get the word out about what studies are going on. I hope you don't mind I moved it into a new thread so it will be more visible, for those who may be interested in participating. I will call and try to get some more details about this to post.

**rhohltjr** · 01-Mar-2005, 11:56

OK then ...what about....

Rebecca,

Is there any study being done on trying to quicken (or start) the nerve
regeneration in the corneas of patients after LASIK? I was prescribed
a suppposedly mild steroid drop just before, and after my Lasik. I can't say it did even as much as the Restasis.

Robert.

Rebecca, please feel free to move my posts anywhere you like. I try to place them in appropriate areas however, sometimes they would be better suited somewhere else.

**Rebecca Petris** · 01-Mar-2005, 12:06

Robert,

Work has been done in the area of Nerve Growth Factor (NGF) for years now, mostly in Europe I think, but I'm not sure how much if any has been done on human subjects. Honestly, I am not well read in that area at all. I think that one possible source of info is the forum archives at VSRN (formerly SurgicalEyes) here.

It's on my list of things to learn more about and I am also hoping to get as much as possible of the latest NGF scuttlebut during the Madrid meeting next month.

**Rebecca Petris** · 01-Mar-2005, 14:33

Here is a link for the site advertising the clinical study Grandmajane mentioned:

www.eyesdry.com

I spoke with a coordinator this afternoon, they are going to work on putting together some more information for us to post here about it. Thanks again GrandmaJane for the lead!

**dianat** · 01-Mar-2005, 15:07

Dr. Holly's drops

Grandmajane,

What a story yours is. I am also suffering, but from post refractive surgery dry eye. I do not envy the lengths to which you have gone to find comfort. Thanks for the info on the study. I may give them a call.

Have you tried Dr. Holly's eye drops? They're described on this site. Many, many peopel have benefitted form them.

Dianat

**grandmajane** · 02-Mar-2005, 07:17

Eye drops and sun glasses

Dianat
No I have not tried Dr Holly's eye drops - I just found this site a couple of days ago - When I was going to the eye institute - I had a very rare eye infection under the eye lids and could hardly see- lights were a killer for me - as was seeing in general - they kept trying all different kinds of medicines and drops - with no success. I went thru 4 sets of plugs and still no luck so then they decided to do the 2 surgerys. That helped some what - but I still have a lot of problems with bright lights and the sun - in fact I have not been able to drive a car since the 2nd week of March last year. The other thing that might help others out there is - in July of last year my eye dr told me of a new pair of sun glasses that were out there and that I had to get ahold of them and use them all the time. What they are is sun glasses that Harley riders use for keeping the wind and dust out of their eyes - for people with dry eyes - they are now using them for severe dry eye patients - to help keep the drops in your eyes longer to give you longer relief. I use them all the time when I go out and especially at nite at the car lights just about blind me.
You have to go to a Harley Davidson dealer to try on the different style of frames on - then they give you a form to fill out - you then go on the internet to pick out the different types of lenses that you want (color and different types of darkenss) If you go the Harley Davidison site they will tell you if there is a store near you to go. Any way the name of the glasses is Panoptx - www.panoptx.com - 1-925-484-0292 - FAX 1-925-484-0263 - if you have a prescription you will need the prescription to give them - once you order them - you can not return them - I paid $490.00 for them and it was money well spent - and you can use it on your taxes. They look like regular sunglasses - but they have rubber inserts that go around your eyes to protect them and keep the medicine in longer. This is the best thing that has happened to me since this all started besides the research study. I REALLY RECOMMEND LOOKING INTO THE GLASSES IF ANYONE IS REAL SENSITIVE TO LIGHTS AND NEEDS TO KEEP DROPS IN LONGER . HOPE THIS INFO WILL HELP SOME OF YOU

**Rebecca Petris** · 02-Mar-2005, 09:36

Panoptyx

Panoptyx has indeed proven a terrific resource for a lot of patients with severe dry eye, both in terms of sealing in moisture and protecting photophobic eyes. I first heard about them on SurgicalEyes way back when. Thanks for posting phone etc details here!!

**Cindy** · 03-Mar-2005, 20:42

Hi grandmajane and welcome! I am a confirmed goggle-wearer. I have one pair each of Harleys, Panoptx and Wiley-X . I've been known to search out and post about goggles once or twice

. You might be interested/entertained in looking at some of the varieties of goggle/eyewear I have found and posted on LaserMyEye's bulletin board: http://www.lasermyeye.org/forums/sho...ooglin+goggles

I've recently tried Tranquileyes. They are a kind of night-time/resting moisture sealing goggle/sleep mask. In other words, you can't see with them on as the ''lens' part is a solid peice of plastic. Not sure yet if I like them or not but I've been playing around with them.

**Erik** · 09-Mar-2005, 14:45

Just was successfully prescreened for the "eyes dry" study today. Turns out that you have to live within 50 miles of a treatment facility. The first person I spoke with asked my zip code and said that I didn't qualify. After thinking about it, I thought that I would call back and let them know that I am willing to travel, and would they sign me up anyway? The nice person with whom I spoke told me that the study is about 70 miles from me, and agreed to sign me up for the pre-screen.

The drug (I learned from doing some research) is rebamipide, and is in two phase III clinical trials right now, of which this is one. I am a cynic when it comes to this stuff, but for what it's worth, this drug does look promising--treats underlying cause of dry eye by stimulating receptors to secrete tears components, rather than just treating the symptoms. The fact that it is in a phase III means that it has shown pretty convincing preliminary results (in phase II trials), and is now being tested on a large scale to guage the degree of benefit (if any).

For the uninitiated:

Phase I = just checking if the drug is safe. Benefit is a secondary consideration. Usually 10-25 patients.

Phase II = larger trial, usually single arm (i.e., no placebo group), which looks for efficacy of the treatment. If successful, it goes to a large, expensive phase III trial, which is multi-center (sometimes multinational), placebo or stanard-treatment controlled, and generally will lead to or nix the chances of FDA approval. A drug company has to believe in a drug to be willing to pay the cost of a large phase III trial.

The other promising drug currently in phase III is diquafosol (a P2Y2 receptor agonist--makes eyes secrete lipid, mucin, water). Prelim results have ranged from very good to mediocre, and FDA approval is not a sure thing at this point with that one.

--Erik

**dianat** · 09-Mar-2005, 17:19

Erik,

Thanks for posting all of this, Erik. I'm glad to know. I'd read the post about the trial and kind of forgot about it. In what state is the study? Maybe I live closer than I think.

To be honest, I can't decide whether I should be participating in things like this. Living day to day in pain takes a lot of energy. Adding a trip like this sounds like a lot of stress.

Still, if I can be convinced it's for the "good" of all uncomfortable dry eye patients, I would do it and be willing to travel. Maybe I'll look into it.

Diana

**kdc66** · 10-Mar-2005, 15:33

Rebamipide

If you want to review the latest dry eye research than go to a web site called ARVO: http://www.arvo.org/root/index.asp. Go to the 2005 abstracts and than the advanced section and in the sessions title select dry eye treatment. I will try to post some of the interesting articles since there are probably 25-30.

Anyway, Eric had mentioned a study on Rebamipide. Here is the presentation on the results they will be doing in May at the ARVO meeting: Eric, I live in Maryland-where are they doing the testing?

Abstract Title: Multicenter, Randomized, Double-Masked, Dose-Response, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Rebamipide (OPC-12759) Sterile Ophthalmic Suspension in the Treatment of Dry Eye
Presentation Start/End Time: Monday, May 02, 2005, 3:00 PM - 4:45 PM
Location: Hall B/C
Reviewing Code: 164 dry eye disease - CO
Author Block: P.C. Donshik1, G.Foulks2, M.Monica3, P.Zhang4, A.Tano5, S.Nakatsu4, S.Bramer4. 1University of Connecticut Health, Bloomfield, CT; 2Ophthalmology, University of Louisville, Louisville, KY; 3Tulane, New Orleans, LA; 4Otsuka Maryland Reseach Institute, Rockville, MD; 5Otsuka Pharmaceutical Company, Osaka, Japan.
Keywords: 461 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled, 481 cornea: tears/tear film/dry eye, 496 drug toxicity/drug effects
Purpose: To evaluate the safety and efficacy of rebamipide ophthalmic suspension 0.5%, 1% and 2% for the treatment of dry eye.
Methods: This was a multicenter, randomized, double-masked, dose-response, placebo-controlled, parallel-group study that evaluated the safety and efficacy of multiple doses of Rebamipide ophthalmic suspension instilled into both eyes for 12 weeks. After a two week run-in period a total of 200 subjects with signs and symptoms of dry eyes were randomized to 4 treatment groups. The primary objective endpoint was fluorescein corneal staining (FCS). Secondary objective endpoints included lissamine green conjunctival staining (LGCS) and Schirmer�s test. The primary subjective endpoint was the subject�s primary ocular discomfort (POD), defined as the subject's most bothersome symptom, identified at screening. Severity of individual dry-eye- related ocular symptoms and the subject's overall treatment impression at week 12 were secondary subjective endpoint.
Results: Compared to placebo at week 12, subjects taking 2% rebamipide showed superiority (p-value<0.05) or favorable trend (p-value<0.1) in mean change from baseline (CFB) for 1)FCS score (p=0.076; p=0.015 at week 6). 2)POD (p=0.044). 3) LGCS (p=0.070). and 4) the individual symptom severity scores of gritty/sandy sensation (p=0.015), burning/pain (p-0.003) as well as the overall treatment impression scores (p=0.044). The 2% rebamipide group was statistically superior to placebo group in mean CFB for Schirmer's test at Week 2(p=0.002) and Week 8 (p=0.034). The safety profile of rebamipide was favorable. No deaths or treatment-related SAE were reported. The incidence of treatment-related eye disorders in the rebamipide treatment groups was less than the incidence of treatment-related eye disorders in the placebo group. Results from other safety assessments were not clinically meaningful.
Conclusions: All three concentrations of rebamipide ophthalmic suspension were well-tolerated and efficacy was demonstrated in dry eye subjects. The concentration of 2% rebamipide appears to be the most effective concentration. There were no serious safety issues in this trial.
Commercial Relationship: P.C. Donshik, Otsuka Maryland Reseach Institute F, C, R; G. Foulks, Otsuka Maryland Reseach Institute F, C, R; M. Monica, Ostuka Maryland Reseach Institute F, C, R; P. Zhang, Otsuka Maryland Reseach Institute E; A. Tano, Otsuka Pharmaceutical Company E; S. Nakatsu, Otsuka Maryland Reseach Institute E; S. Bramer, Otsuka Maryland Reseach Institute E.
Support: None.

**Cindy** · 10-Mar-2005, 17:23

rebamipide

I'd never heard of 'rebamipide'. I did a google search. This is a Novartis product.
Media release:
MEDIA RELEASE - COMMUNIQUE AUX MEDIAS - MEDIENMITTEILUNG
http://dominoext.novartis.com/NC/NCP...3?OpenDocument

Novartis obtains rights from Otsuka to develop new treatment for dry eye

� Novel mechanism of action expected to enhance tear secretion and increase mucin levels covering conjunctiva and cornea

� Over 22 million patients visit ophthalmologists each year seeking treatment for symptoms of dry eye

Basel, February 7, 2005 � Novartis announced today that it has in-licensed rebamipide, an investigational treatment for dry eye, from Otsuka Pharmaceutical Company, Ltd. Currently being tested in two Phase III studies in the US, rebamipide is expected to demonstrate a novel mechanism of action to enhance tear secretion and increase the levels of mucin covering the conjunctiva and cornea of the eye.

Dry eye is a condition characterized by a patient's inability to produce enough tears or the appropriate quality of tears to keep the eye healthy and comfortable. There are currently 22 million patients who visit an ophthalmologist worldwide for dry eye symptoms and many more who self-treat or do not treat their condition at all.

"As dry eye can have many causes and affects a large and growing patient population, there is a high unmet medical need and opportunities exist for several new pharmacological treatment approaches," said Flemming Ornskov, MD, President of Novartis Ophthalmics. "We expect rebamipide to provide distinct advantages to patients over currently available products."

Dysfunction in the delicate balance in the tear film may develop from aging, systemic inflammatory diseases, ocular surface diseases, or different medications. Palliative treatments for dry eye include artificial tears, which patients can self-administer four or more times per day. Unlike artificial tears, which simply lubricate the eyes and help maintain moisture1, rebamipide provides a new and unique pharmacologic approach to treatment of dry eye by increasing mucin secretion. It is expected to increase tear quality and may improve corneal health.

"Novartis sees promise in rebamipide's novel ability to treat dry eye," said Ornskov. "With this in-license agreement, we expect to be able to offer general ophthalmologists a well-rounded dry eye product portfolio that we hope will elevate the standard of treatment worldwide."

Under the agreement, Novartis will obtain an exclusive license with the right to sub-license the compound globally, excluding Japan and selected Asian countries. Novartis will pay an upfront fee and annual royalties. The terms of the agreement were not disclosed.

The foregoing press release contains certain forward-looking statements that can be identified by terminology such as "will," "expected to increase," "expect to provide," "may improve," "opportunities exist," "sees promise," "expect to be able," or similar expressions, or by express or implied discussions regarding the potential that rebamipide will be approved for marketing, or regarding any potential revenues from rebamipide. Such forward-looking statements involve known and unknown risks, uncertainties or other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectations relating to rebamipide could be affected by, among other things, uncertainties relating to clinical trials; unexpected regulatory actions or delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81 400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

References
1 American Academy of Ophthalmology. Dry Eye. 2003
http://www.medem.com/medlb/article_d...1ED&sub_cat=37
# # #

Contacts

Laurie Wooding
Novartis Ophthalmics
Tel +41 61 697 9879 (CH)
or +1 862 778 2104 (USA)
mailto:laurie.wooding@pharma.novartis.com

Lisa Richert
Novartis Global Media Relations
Tel + 41 61 324 3543
or +41 61 324 2200
mailto:lisa.richert@group.novartis.com

**Erik** · 10-Mar-2005, 18:34

[QUOTE=kdc66]If you want to review the latest dry eye research than go to a web site called ARVO: http://www.arvo.org/root/index.asp. Go to the 2005 abstracts and than the advanced section and in the sessions title select dry eye treatment. I will try to post some of the interesting articles since there are probably 25-30.

Anyway, Eric had mentioned a study on Rebamipide. Here is the presentation on the results they will be doing in May at the ARVO meeting: Eric, I live in Maryland-where are they doing the testing?
[QUOTE]

The clinic I am going to is in Fredricksburg, VA, about 1 hour south of DC. A bit of a haul for me (I live 10 minutes north of DC), but will be well worth it if this stuff works (though I have a 33% chance of being in the placebo group). Even if not, I'll at least know that I tried. Somehow I get comfort in knowing that I am putting up a decent fight...

**Erik** · 10-Mar-2005, 18:37

Oh, and one other thing: you get paid to be in this trial. Not that it's a lot, but perhaps a moral victory to actually make (rather than lose) money due to our post-lasik woes. Probably around $1000, I'm guessing, given the amount of clinic visits (12), lab visits (4), and a daily diary-by-phone--I'll let you know.

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