KCN Treatment Options

We have a lot of ways to help you manage your KCN suspects and patients.  

We can see your KCN suspects and patients for Pentacams to help you follow them more closely in your office.  If you desires scans only for your patient, please work directly through me at jen.weigel @ tlcvision.com so that I can help you schedule the appointment correctly.

If you would like to have them considered for Intacs or corneal transplant, we can help your patient schedule an evaluation with Dr. Solomon.  Dr. Solomon sees patients for consultation one-two Sunday mornings a month.  If you desire an evaluation for your patient, I can help you schedule the evaluation for your patient.  

Stay tuned for more information on CXL through Dr. Holzman. - jw (10/23/16)

CXL Coming to a TLC Near You

posted Oct 31, 2016, 11:06 AM by Jen Weigel

October 28, 2016
 
Dear Doctor,
 
We are excited to announce that TLC Tysons Corner will begin offering the corneal cross-linking procedure very soon.  As you may already know, the FDA recently approved corneal cross-linking using KXL light system and Photrexa Viscous/Phorexa riboflavin formulas. This specific treatment combination is currently the only FDA-approved therapeutic modality for patients with progressive keratoconus.  For the first time, we now have an effective treatment clinically proven to prevent or slow down progression for our keratoconus patients.
 
How it Works
 
The procedure is simple for patients: Riboflavin eye drops are applied to the cornea for 30 minutes after epithelial removal, followed by exposure of the cornea to KXL light system for another 30 minutes. The procedure works by creating new corneal “cross-links”, which results in stiffening and strengthening of stromal tissue.
 
Benefits to Your Patients
 
•             The only FDA-approved, non-surgical keratoconus treatment available
•             The only treatment proven to halt or slow down the progression of disease
•             The only treatment shown to clinically stiffen corneal tissue
•             The only FDA-approved procedure that provides a true long-term solution for your patients
 
Who is Eligible?
 
Corneal cross-linking can be indicated for any patient who has been diagnosed with progressive keratoconus and who is 14 years of age or older.
 
Your patients’ vision and quality-of-life are very important to TLC and that is why we will be adding corneal cross-linking as a new service offering.  These patients often require ongoing care and advanced contact lens fittings as their cornea remodels over time.  As always, your expertise is an integral part of our co-management relationship. This is essential to ensure that treatment success is achieved for each patient in the long run. We will be happy to discuss how best to manage these cases with you.
 
Should you have any questions about corneal cross-linking, please do not hesitate to contact us. As always, we thank you for your continued support and trusting TLC with your patients.
 
Sincerely,
 
Your TLC Tysons Team
 
Andrew Holzman, MD, FACS, Regional Medical Director      
Jen Weigel, OD, FAAO, Clinical Director
Natasha Carter, Center Manager       
Joan Reich, Professional Relations Consultant

CXL Approved by FDA for Treatment of Post-LVC Ectasia

posted Oct 15, 2016, 9:59 PM by Jen Weigel

July 19, 2016

Great job, Avedro, for gaining FDA approval to use CXL for post-LVC ectasia treatment!

CXL for KCN Approved by FDA!

posted Oct 15, 2016, 9:57 PM by Jen Weigel

April 18, 2016

Dr. Jablonski must be good luck!  For the past few years, CXL has failed to obtain FDA approval, despite its well-documented history in many other countries.  Dr. Jablonski texted to ask about the status of CXL, and I promise you, the next week it got approved!  YEA!

FDA Denies Approval for CXL ... Again

posted May 2, 2015, 2:09 PM by Jen Weigel

Ugh.  Again, Avedro failed to secure FDA approval for CXL for KCN and post-LASIK ectasia patients. 

The study that we were involved in sought to study two things:  the riboflavin used in the procedure (drug) and the UV lamp used in the procedure (device), both of which need FDA approval before CXL could become a viable option for patients. 

Even before we completed our study, Avedro had announced a new version of the UV lamp.  Which, to me, was kind of confusing.  My thought was, why would you do that when you still have an active study going on?  But, I'm also not able to stop the tide of technological advancement.

So, from what I can seem to gather, Avedro is seeking approval for this new lamp based on the study results using the old lamp?  I think that's just adding to confusion in the FDA approval process.

Anyhow, we are STILL waiting for FDA approval for CXL.

In the meantime, how many KCN patients have I had to refer for Intacs since that is our only viable, FDA-approved treatment option?  Thank goodness I have only had to refer on patient for corneal transplant!  That's good news, I feel, because maybe that means we are diagnosing patients earlier and helping to preserve their vision! - jw

Avedro Heads Back to the FDA

posted Oct 6, 2014, 5:49 PM by Jen Weigel

Earlier this year, the FDA's judgement on Avedro's accelerated corneal crosslinking procedure for the treatment keratoconus and post-LASIK ectasia said that the FDA required more information prior to approving this procedure.

On September 30, 2014, Avedro resubmitted it's New Drug Application to the FDA.  Keep your fingers crossed for a positive response from the FDA come March 2015.

Avedro Introduces KXL II and Adds to it's Riboflavin Line

posted Jul 5, 2014, 5:36 PM by Jen Weigel

Two "recent" announcements by Avedro have been made.  I say "recent" because it's been a while since I've made posts, so I'm catching up here.

First, at the end of April, Avedro received Candadian approval for KXL II ™ Advanced Cross-Linking System.  This was the first that I'd heard of the KXL II process.  Basically, it allows for a procedure called PiXL™ (Photorefractive Intrastromal Cross-Linking).  Now, I have to admit that the news brief about it didn't really make much sense to me, so I asked Avedro for more information.  From what I can understand since I didn't have many resources on this topic, PiXL allows one to control the amount of cross-linking done in specific areas of the cornea, and this selective cross-linking can correct vision without having to use an excimer laser.  Now, don't quote me on this.  I'm supposing that we'll learn more about this in due time.

In June, Avedro expanded its presence in the riboflavin supply market.  Who knew there were that many suppliers of riboflavin?  In re-reading this press release today, I did have to chuckle when I read the following line:  "David Muller, PhD, CEO of Avedro commented, 'I am extremely pleased to have consummated this important transaction with Medio-Haus.'"  Hmm ... consummated?  I think the use of a thesaurus should come with a warning for some users.  Or, where was his editor?  - jw

FDA Issues Response to Avedro's New Drug Application for Corneal Cross-linking

posted Mar 23, 2014, 3:35 PM by Jen Weigel

Well, a couple of things ...

One, I was surprised that the FDA stuck to their deadline of March 15 for issuing a ruling on the NDA for cross-linking.  When has the government ever been good about sticking to a deadline, especially lately?

Two, I knew it was too good to be true to hope that they'd rule in favor of approving the procedure.  Mind you, I don't think that I read anywhere that this response would include approval, especially since our study is still on-going, but I did have high hopes!

Looks like we are still in the compiling data stage in our study.  It's been pretty cool to see our patients progress and work directly with Avedro as they've implemented the study across the country. 

Check out the original press release from Avedro here.  - jw

TLC's Dr. William Tullo Discusses CXL at SECO

posted Mar 23, 2014, 3:28 PM by Jen Weigel

I can't begin to tell you how much I've learned from Dr. Tullo, the top TLC OD, since I joined the team just over two years ago.  He's been a wonderful resource for learning more and more about corneal tomography analysis and now keratoconus treatment.

Check out this video segment that was taped at this year's SECO meeting featuring Dr. Tullo.

The crosslinking study that Drs. Holzman and Solomon have been involved in has been exploring treatment for KCN patients that have actually had loss in their BCVA prior to enrollment.  This is an explicit study inclusion criteria.  However, like Dr. Tullo mentions here, once this procedure is FINALLY ... ugh ... waiting forever here ... approved, then we can feel safe in recommending it as a treatment modality for our patients that definitely have KCN and are at risk for losing BCVA due to the progressive disease.  - jw

Priority Review Status for Accelerated Corneal Cross-linking

posted Dec 2, 2013, 2:33 PM by Jen Weigel

At the end of November, the FDA notified Avedro that they will be given Priority Review Status for their New Drug Application (NDA) for their proprietary Riboflavin/Accelerated Corneal Cross-linking procedure.  This is great news for all the patients that we saw that need cross-linking but could not yet qualify for the study.  A lot of these patients in need had KCN, but they did not have enough drop in VA yet to qualify for the study.  The study guidelines make 100% complete logical sense, don't get me wrong.  You can't run a study on patients that are 20/20 BCVA, I get that.  But, when this whole system gets approval, I'd love to start saving and preserving vision on a greater number of KCN patients!

So, what is Priority Review Status?  Seems there is something called Prescription Drug User Fee Act (PDUFA) which allows companies to pay larger fees when they request their application to be reviewed.  When the company pays a larger fee, the FDA can provide more reviewers, and this accelerates the review process.  From what I can gather, they can do this for medications and procedures that have shown to be of good benefit to patients.  It's a way to get what is needed out there faster.  It can cut the FDA's review time from 10 long months to just 6 short months!  

According to Avedro, the FDA's action date deadline is March 15, 2014.  Can't wait to see what happens!  - jw

Avedro to Develop Instruments to Test Corneal Biomechanical Strength

posted Dec 2, 2013, 9:57 AM by Jen Weigel

Avedro is working toward developing instruments to test a cornea's biomechanical strength.  This would pair well with their work in KCN treatment with cross-linking.

I really didn't understand the science behind this technology, and I really didn't understand my physicist husband's explanation of Brillouin scattering which is the scientific principle upon which these diagnostic instruments will be based.  The Wiki page didn't help much either.  You can read the press release on this announcement here.  See if you can learn any more about Brillouin scattering than I did.  : )

What this comes down to is that we can hopefully use this technology once it's developed to more accurately assess KCN corneas.  This will help us - and the patients - decide on the appropriateness of cross-linking to help control their disease process.  - jw

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