Under the Same Sun: The Recurrence of KC after Penetrating Keratoplasty Corneal Transplantation

Jenny Deva MD

Consultant Ophthalmologist & Contact Lens Specialist

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For Your Viewing Pleasure: Optometric Management - Are Specialty Lenses for You?

Converse long enough with optometrists who operate thriving specialty contact lens practices,
and you will likely notice a recurring story. It involves a patient with a challenging
underlying condition (frequently Keratoconus) who goes from clinician-to-clinician,
sometimes for years...

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Avedro, a US based pharmaceutical and medical device company, has received the US Food and Drug Administration (FDA) orphan drug status for VibeX (0.1.% riboflavin ophthalmic solution) to be used with its KXL System (UVA illumination) for Corneal Cross-linking as a treatment for Keratoconus.

Avedro's KXL, VibeX and Keraflex are CE marked and are commercially available outside of the US.

At present, the company has submitted an additional application for orphan drug designation for cross-linking for the treatment of Corneal Ectasia following refractive surgery.

Avedro CEO David Muller said this orphan drug designation, along with the encouraging clinical results from our Phase III Keratoconus study, is another important step in bringing this technology to patients in the US.

David Muller - "We look forward to working with FDA as we progress towards an NDA submission in the very near future."

 

Purpose: To evaluate corneal tomographic features of Keratoconus and associations between risk factors and disease phenotype in New Zealand.

Setting: Departments of Ophthalmology, University of Auckland and Auckland District Health Board, Auckland, New Zealand.

Design: Clinic-based, cross-sectional study.

Methods: The medical records and corneal tomography of patients attending a subspecialty service were reviewed. Data included age, sex, ethnicity, ocular history, family history, atopy, and eye rubbing. Orbscan II parameters included simulated keratometry, mean power, pachymetry, location of maximum power, anterior best-fit sphere (BFS) and posterior BFS. Morphology was categorized by the Rabinowitz topography classification.

Results: Final analyses included 532 eyes (266 patients; 144 men) with a mean age of 29.3 years ± 11.56 (SD). Maori and Pacific patients were overrepresented (P=.0001). Family history of keratoconus was associated with a lower mean corneal power (P=.01) and greater pachymetry (P=.03). Comparing patients with family history and patients with atopy, showed differences in thinnest-point pachymetry (mean: family history, 340 ± 15 μm; atopy 381 ± 8 μm) (P=.0218). Keratoconus was classified as severe (58.3%) or moderate (33.8%) on mean keratometry. Axial keratometric maps were predominantly asymmetric bow-tie (29%), round (18%), or inferior steepening (17%). Anterior elevation maps were classified as spur (49.3%), island (24%), irregular ridge (15%), or other (11.3%). Eighteen patients (12.5%) had complete enantiomorphism.

Conclusions: Advanced Keratoconus was largely asymmetric and differences in tomographic phenotype were associated with differing etiologic risk factors. Maori and Pacific ethnicities were overrepresented in this population.

Multi-Center US Phase III Studies for the Treatment of Progressive Keratoconus and Ectasia Following Refractive Surgery.

WALTHAM, Mass, May 17, 2011— Avedro, Inc. today announced the completion of all one-year follow-up visits for patients enrolled in its two multi-center Phase III studies evaluating the safety and efficacy of corneal collagen cross-linking for the treatment of progressive keratoconus and ectasia following refractive surgery.

Keratoconus is a degenerative disease of the eye and is the leading cause of corneal transplants in the US today. Ectasia following refractive surgery is a complication following various types of surgery, including LASIK, a surgical procedure for correcting myopia (short sightedness) and hyperopia (far sightedness). Outside the US, Cross-linking has been deemed safe and effective and is approved for use in treating keratoconus and ectasia post-refractive surgery.

Dr. Peter Hersh, a leading refractive surgeon and Medical Monitor for Avedro’s clinical trial stated, “Avedro’s efforts to make this clinically important treatment available to US patients is applauded by all US ophthalmologists who today lack any approved therapeutic treatment to halt the progression of these sight threatening conditions.”

“I am extremely pleased that we have reached this important stage in the US clinical trials and our team is working diligently to accomplish a timely analysis of data,” said David Muller, CEO of Avedro. “Outside the US, cross-linking has become the standard of care for treating weak and ectactic corneas. It is our hope to bring this technology to the US in the near future.”

Avedro, a privately held ophthalmic device and drug company based in Waltham, MA, developed the KXL System for performing Accelerated Cross-linking and Lasik Xtra. Avedro has also developed the Vedera System for performing Keraflex, a non‐invasive, incision‐less ophthalmic procedure for flattening the cornea. Because Keraflex thermally remodels the cornea without the removal of any tissue, the procedure offers the unique ability to induce refractive change without weakening the cornea’s biomechanical integrity, as happens with LASIK and other refractive correction procedures. Both devices and procedures are CE marked and commercially available outside of the United States.

Paulig Augenklinik is The World's First Ever Clinic for Keraflex Vision Correction

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Doing Everything Humanly Possible: Keratoconus Patients in the News

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 A Revolution in Corneal Reshaping and a Breakthrough in Accelerated Cross-linking. Live Surgery at ESCRS.

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A World about Us: The APAO & AAO Joint Congress Beijing 2010

By Our International News Correspondent

Held at the China National Convention Center (CNCC). The Joint Congress of the Asia-Pacific Academy of Ophthalmology (APAO) and the American Academy of Ophthalmology (AAO) in combination with the 15th congress of the Chinese Ophthalmological Society. The 2010 Joint Congress also celebrated the 50th anniversary (Golden Jubilee) of APAO.

It was once again a meeting of great minds in every subspecialty of Ophthalmology. Beijing was beautiful. The slightly cooler than average weather temperatures made it a pleasant stay. It was certainly a meeting where landmark decisions was made for the future of Ophthalmological education.

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Member of Parliament in New Zealand is Our Man in Politics

I am Aaron Gilmore a Member of Parliament for the Governing National Party in New Zealand and I have 'suffered' from Keratoconus for about 15 years now. Given my job I am walking proof that this annoying eyesight condition does not have to rule your life as though it is a pain, it does not need to make you a victim.

Aaron's Website www.aarongilmore.org.nz
Party Website www.national.org.nz

Anterior Chamber Characteristics of Keratoconus Assessed by Rotating Scheimpflug Imaging

Illés Kovács MD, PhD, Kata Miháltz MDa, János Németh MD, DSca and Zoltán Z. Nagy MD, DSca

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Guest Access

Semmelweis University, Department of Ophthalmology, Budapest, Hungary.

More Than 30 years Distinguished Service for the Eye Care Industry

Irving Arons

Irving Arons is a leading and highly experienced commentator on ophthalmic technology and industry issues.

Retired after more than 30 years of consulting in the ophthalmic and medical laser industries. Eleven years as managing director of Spectrum Consulting, including publishing Executive Laser Briefing; twenty-five years at Arthur D. Little, as manager of the Ophthalmic and Medical Laser Consulting Group.

Currently publishes :

Only retired people know that retired people never really retire. People in the Industry who retire automatically become, by popular demand - teachers in the field, role models, mentors, commentators, opinion leaders. Retirement becomes one of discovery - new found time, new found freedoms, new social networking, and new current affairs to review, with a renewed independence.
 
Retirement allows the sharing of the three gifts - of life, love and laughter, given to you at birth even more now with the rest of the world - and these gifts being special because they never diminish in size the more they are shared.

Remember, back in the day the industry's past and present seniors. They have been determined to extend themselves in pro bono efforts benefiting their fellow colleagues in the field, and they have made our community a better place to live.

It is never too late to seek a newer world.

The company prepares for immediate commercial launch throughout Europe and Asia

Waltham, MA, April 20, 2010 — Avedro, Inc. today announced its Vedera™ System for performing the Keraflex® procedure has received the European Union's CE Mark. The CE Mark certifies the Vedera has met the EU's health and safety standards and opens the door to commercialization across the European Economic Community and in other countries recognizing the CE Mark.

"I am pleased by how quickly Avedro has been able to transform its Thermo-biomechanics platform technology into a commercially available ophthalmic device. Avedro has been conducting clinical trials to treat myopia and keratoconus with the Keraflex procedure and is extremely pleased with the results. CE Mark certification is an important milestone for the company, and also represents a vital new offering to ophthalmic patients and their physicians," said David Muller, PhD, President and CEO of Avedro.

The Keraflex procedure is a non-invasive, incision-less ophthalmic procedure for flattening the cornea. Because Keraflex thermally remodels the cornea without the removal of any tissue, the procedure offers the unique ability to induce refractive change without weakening the cornea's biomechanical integrity, as happens with LASIK and other refractive correction procedures.

Keraflex KXL, Corneal Flattening and Corneal Stabilization

In its European clinical trials for the correction of myopia and the treatment of keratoconus, a progressive disease of the cornea, Avedro has investigated a two-step procedure whereby Keraflex provides corneal flattening to achieve refractive correction and concomitant collagen crosslinking stabilizes the cornea.

"The Keraflex procedure, by thermally altering the tension of collagen fibers, induces a corneal flattening and achieves a more prolate cornea. This confers refractive correction, and, for the keratoconic cornea, smoothing of the irregular cornea, thereby improving visual acuity. The synergistic use of corneal collagen crosslinking improves the stability of the induced refractive effect while also working to halt disease progression," explains Prof. John Marshall, PhD, Institute of Ophthalmology, University College, London.

The company plans to immediately begin commercialization of the Keraflex procedure throughout Europe and Asia, and looks forward to training and collaborating with its ophthalmic surgeon partners.

Avedro, a privately held medical device company based in Waltham, MA, is developing the science of Thermo-biomechanics for therapeutic medical applications. Keraflex® KXL is the first technology Avedro has developed from its Thermo-biomechanics platform. Avedro recently announced it has signed a definitive agreement with Peschke Meditrade GmbH to acquire the rights to its US-based Phase III studies of corneal collagen crosslinking for the treatment of progressive keratoconus and post LASIK ectasia. The company looks forward to closing the follow-up phase of the studies and completing the necessary steps to introduce crosslinking to the US market. For more information, visit www.avedro.com

"Since these trials were initiated, over 300 subjects were treated with corneal collagen crosslinking. Avedro now looks forward to closing the follow-up phase of the study and completing the necessary steps to introduce this exciting technology into the US," said David Muller, PhD, President and CEO of Avedro.

Corneal crosslinking combines the application of riboflavin with ultraviolet-A light. Together, these increase corneal strength and stability by inducing new crosslinks between or within collagen fibers. In multiple international clinical trials, crosslinking has been shown to halt the progression of keratoconus and ectasia and to enhance the biomechanical stability of the cornea. Crosslinking is now approved for use Internationally outside the US. "Collagen crosslinking has been accepted as an important advance in the treatment of keratoconus by surgeons around the world. I am very excited that the experienced team at Avedro is taking over the US clinical trials initiated by my company and completing this important work," comments Rudi Peschke, CEO of Peschke Meditrade GmbH.

I can't even begin to tell you how much this International Organization helped us when we first found out that my son has KC.

We went the route of trying different kinds of contacts, but he felt pain in his eyes when he used them and he gave up on them. He has glasses now which corrects one eye. The other eye has just a clear lens since it can not be corrected.

In one month he will be 19, and this year he is doing a year's service for the country before enlisting in the IDF (Israel Defence Force). The year's service includes working with the youth movement in small villages, plus working with autistic children. He has grown up a lot these last few months, learning how to budget money with a small group of volunteers who all live together in a common house. They buy their food, use the money for travelling and whatever else they need. It's a good lesson for life in general.

As for the army, he got a low profile because of his Kerataconus which means he can't be in a combat unit. So who says Kerataconus is all negative? (don't tell him I said that). He has been accepted into an officer's training unit after his year's service is over, and hopefully he'll acquire skills there that he can use after his service. Both his sister and brother are officers in the army too. So is his Dad. That's what happens when a country is so tiny. Everyone helps out.

And I've learned all sorts of healing methods from Reiki, Rising Star, Matrix Energetics, Reconnective Healing. I have used them all on my son (in vain!). I'm still waiting for him to say: hey! I can see in both eyes!

I did help him when he had the flu. So I guess I can't complain...