Tuesday, March 22, 2011

Menu 18: Updates for October 2010 – March 2011

I have been negligent in updating the menus for my online Journal. So, here is the update for the past six months.

This update contains a number of new writeups, including the first use of gene therapy in treating retinitis pigmentosa; an overview of what happened at the Second Ophthalmic Innovation Symposium (held last year just prior to the AAO Meeting), a couple of interviews conducted by my colleague in China during lat year’s APAO Meeting in Beijing, and an excellent writeup about how femtosecond lasers are being used in ophthalmology.

I have also included several updates on subjects I have been closely following, including the controversy between the use of Avastin or Lucentis in treating AMD; an AMD update; a CATT Study update; five updates on the use of stem cells in ophthalmology; and updates on the latest news from Iluvien and NeoVista.

Here are synopses and links for the recent postings:

Avastin/Lucentis Updates:
Avastin/Lucentis Update 42: One-Year Results of Controlled Comparison Study Published (Oct. 4, 2010)

Last October (2009), I came across the six-month results of one of the first blinded, double-masked comparison studies run between Avastin and Lucentis, sort of a mini-CATT Study. This study was done by researchers at the Boston University School of Medicine in cooperation with the VA Boston, and was published in the American Journal of Ophthalmology. I published their news release describing the study and the six-month results as Avastin/Lucentis Update 29.

This weekend, the same group announced the one-year results of this study, this time published in Eye, a peer-reviewed publication of The Royal College of Ophthalmologists in the UK.

Avastin/Lucentis Update 43: Secret Rebates Offered for Lucentis (Nov. 4, 2010)

First, Genentech refused to provide Lucentis for the CATT Study, being run by NEI/NIH to compare Avastin to Lucentis for AMD (Avastin/Lucentis Update 12); then they threatened to stop supplying Avastin to compounding pharmacies so that ophthalmologists could continue to obtain the drug for their patients (Avastin/Lucentis Update 18); then they decided to provide Lucentis free of charge for the study looking at the use of panretinal laser treatment plus anti-VEGF (Lucentis) in the treatment of diabetic macular edema – at the exclusion of Avastin, in that “pay to play” study (Avastin/ Lucentis Update 37); and now, the company is offering secret rebates to selected large users of Lucentis – obviously to blunt the potential expected to be offered by Avastin when the CATT Study results are released next Spring.

Here, as written by Andrew Pollack online yesterday and published in today’s NYTimes, is the latest story in the ongoing Avastin vs. Lucentis Controversy:

Avastin/Lucentis Update 44: United Kingdom Closer to Allowing Avastin for AMD (Dec. 8, 2010)

While the U.S. comes closer to showing the equivalency of Avastin to Lucentis for treating the wet form of age-related macular degeneration, when the CATT (Comparisons of Age-Related Macular Degeneration Treatments Trials) Study results become public, hopefully, some time this Spring, the UK’s health services are still fighting over whether or not they should study the two drugs to determine if Avastin would be appropriate for the Brits to use in their National Health Service.

Avastin/Lucentis Update 45: Avastin Drug Treatment for ROP Better than Laser (Feb. 26, 2011)

A new study, published earlier this month in the New England Journal of Medicine, describes the use of intravitreal Avastin to treat Retinopathy of Prematurity (ROP) in premature infants.

This study was widely covered by the press, but I would like to reproduce just a few of the presentations to provide you with the information necessary to best understand the results of this study.

AMD Update:

AMD Update 13: Retinal Procedures on the Rise (Oct. 13, 2010)

A new study, just published in the October issue of Archives of Ophthalmology and reported by Ophthalmology Web, MedPage Today, and Medscape Medical News,  shows that among those in the Medicare population (age 65 plus), treatments for retinal conditions nearly doubled between 1997 and 2007 – and this trend is expected to continue with the aging of the population and seniors living longer.

CATT Study Update:
CATT Study Update 12: Status of WorldWide Studies (Jan. 6, 2011)

With the anticipated arrival of the one-year results of the CATT Study this Spring, I thought it would be appropriate to update where the other worldwide studies stand.

During the Retina Subspecialty Day sessions, held prior to the recent 2010 AAO Meeting in Chicago, Daniel Martin, MD provided an update on the various comparative studies underway around the world between Avastin and Lucentis. Here are Dr. Martin’s comments, as reported by the Market Scope team in the November issue of Ophthalmic Market Perspectives.

Stem Cells in Ophthalmology Updates:
Stem Cells in Ophthalmology Update 2: ACT Gets Go-Ahead to Treat Stargardt’s (Nov. 23, 2010)

As I noted in my September report on the Use of Stem Cells in Ophthalmology, it was anticipated that either the program at The London Project to Cure Blindness or Advanced Cell Technology’s program to treat Stargardt’s disease would be the first to get the go-ahead to begin approved human trials. I have not heard any news out of London, but earlier this week ACT received notification from the FDA that it was cleared to begin its human trials with human embryonic stem cells.

Stem Cells in Ophthalmology Update 3: ACT Files IND to Treat Dry AMD (Nov. 30, 2010)

Furthering its lead in stem cell research in ophthalmology, Advanced Cell Technology Inc., announced today that it  had filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration, to initiate a Phase I/II multicenter study for the  treatment of dry Age-Related Macular Degeneration (dry AMD) using human embryonic stem cell (hESC) derived retinal pigment epithelial (RPE) cells.

Stem Cells in Ophthalmology Update 4: ACT Receives Receives FDA Approval to Use hESCs to Treat Dry AMD (Jan. 3, 2011)

Advanced Cell Technology Inc., announced today that it  had received approval from the FDA to commence its clinical trial using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to treat the dry form of age-related macular degeneration. ACT is now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with dry AMD, the most common form of macular degeneration in the world. There are currently no approved treatments available for this prevalent disease of an aging global population. Dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans, and a further 10 million Europeans.

Stem Cells in Ophthalmology Update 5: Gene Defects Common in Induced Stem Cells (Mar. 5, 2011)

As the senior editor, John Gever, of MedPage Today reported, following the publication of three studies about induced pluripotent stem cells in the March 3rd, issue of Nature, “The road to regenerative medicine based on induced pluripotent stem cells (iPSCs) may have developed a giant pothole, with new studies showing that the cells are prone to several types of genetic defects.”

The three studies showed that the reprogramming process and subsequent culture of pluripotent stem cells in vitro can induce genetic and epigenetic abnormalities in these cells. The authors of the studies and the editorialist said that the results raise concerns over the implications of such aberrations for future applications of pluripotent stem cells.

Stem Cells in Ophthalmology Update 6: Stemedica Paper Accepted for Presentation at ARVO (Mar. 19, 2011)

I recently received an update from my contact at Stemedica and would like to share the information with you.

A safety study on the use of  stem cells in the eye, in a clinical study underway at the Fyodorov Federal Institution of Eye Microsurgery in Moscow, to treat diabetic retinopathy and diabetic optical neuropathy with stem cells derived from bone marrow, has been accepted for presentation as a poster at the upcoming ARVO Annual Meeting in Fort Lauderdale at the beginning of May. An abstract is shown below.

Iluvien Update:

Iluvien Update: FDA Marketing Approval Delayed (Jan. 5, 2011)

Last July, I wrote a comprehensive report about Iluvien and the status and promise of other sustained release drug delivery systems (Iluvien and the Future of Ophthalmic Drug Delivery Systems). At that time, Alimera Sciences, the company developing Iluvien (under license from pSivida) had filed a new drug application (NDA) to treat diabetic macula edema (DME). The company obtained priority review status for the NDA at the end of August, raising the expectation that an approvable letter might be obtained by the end of 2010.

However, instead of an approvable letter, Alimera Sciences received a “complete response letter” (CRL) from the FDA, communicating to the company that its NDA application “cannot be approved in its present form”.

NeoVista Update:

NeoVista Epi-Retinal Strontium 90 Treatment for AMD: Update 4 (Jan. 20, 2011)

NeoVista just released an update, discussing the first commercial utilization of its Epimacular Brachytherapy device in Germany. The Epi-Rad device, now renamed as the VIDION ANV (Anti Neo Vascular Therapy System) has been commercialized in Europe since November 2009. The first patients treated were in Pisa, Italy, quickly followed by patients treated in London, UK, also in November of 2009, and now in Hamburg, Germany this month.

And, here are the new writeups:
The Use of Gene Therapy in Treating Retinitis Pigmentosa and Dry AMD by Retrosense (Nov. 6, 2010)

A short while ago, I received a message from someone I did not know, who said that he enjoyed the writeups on my online Journal and was wondering if I might be interested in writing about the use of gene therapy as an approach to vision restoration. Since I knew absolutely nothing about gene therapy, the writer got my attention.

After several discussions with Sean Ainsworth, the founder of RetroSense, and much online research, I think I have learned a little about what gene therapy is about, and its application in ophthalmology, especially in the possible restoration of vision in those who suffer from retinitis pigmentosa (RP). Thanks to Sean for whetting my appetite -- here is what I have learned.

The Second Ophthalmic Innovation Summit (Dec. 10, 2010)

Last October, the Second Ophthalmic Innovation Summit (OIS) was held just prior to the 2010 AAO Meeting in Chicago. As was the case last year, my old friend, Larry Haimovitch,an ophthalmic industry veteran, who attended the meeting and wrote about it for the sponsor’s website, Healthcare Syndicate has given me permission to reproduce his writeup in this space.

An Interview with Dr Ronald Krueger (Feb. 17, 2011)

With the permission of Lei Zang, the Managing Editor of Ophthalmology World Report, here is her interview with noted refractive surgeon Dr. Ronald Krueger of the Cleveland Clinic. As noted below, Dr. Krueger was recently in China to perform a corneal transplant on a Mongolian patient and while there, attended the APAO Meeting held last fall in Beijing, where Ms. Zang had the opportunity to interview him.

An Interview with Professor John Marshall (Feb. 17, 2011)   

During the APAO (Asia Pacific Academy of Ophthalmology) Meeting held in Beijing in September, 2010, Lei Zang, the Managing Editor of Ophthalmology World Report,  interviewed Professor John Marshall of St. Thomas Hospital in London and the principal behind the Ellex 2RT (retinal regeneration) program for Ellex Laser, and also an investigator (and inventor?) of the Avedro microwave corneal crosslinking program.

In this interview, Prof. Marshall discussed both his work on 2RT and on microwave crosslinking as well as several other topics that will be of interest to ophthalmic researchers.

A Comparison of Commercially Available Femtosecond Lasers for Refractive Surgery (Mar. 17, 2011)

Over the past several years, I have either written or posted other peoples accounts of the use of femtosecond lasers in ophthalmology. Starting with the history of their development in October 2008 (Intrastromal Ablation: A Technology Whose Time Has Come?); an article on the use of the femtosecond laser to treat presbyopia by Dr. Rupal Shah in June 2009  (Another Approach to Intrastromal Ablation); a writeup on the use of femtosecond lasers for performing cataract surgery by Larry Haimovitch, again in June 2009 (Femtosecond Lasers Proposed for Use  in Cataract Surgery); and finally, Dr. Joseph Colin’s writeup about femtosecond laser cataract removal as a second revolution, and my addition about the possibility of using the femtosecond laser to “bleach” the natural lens to delay the onset of needing to remove catatacts, inAugust 2010 (Femtosecond Laser Cataract Removal: The Second Revolution? And, What is Laser Photolysis?).

Earlier this month, I came across an article written by Drs. Ronald Krueger and Glauco Reggiani-Mello, of the Cleveland Clinic, that does an excellent job of summarizing the latest developments in the use of femtosecond lasers in refractive surgery and other applications in ophthalmology. Since the article was written in a professional journal – Expert Review of Ophthalmology, with limited access, I asked the authors for permission to reproduce a significant part of their writeup, along with a link to the original for those that wish to read it in its entirety. Permission was granted, and here is my version of what was presented, along with most of their illustrations and their two tables.


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