Sunday, June 05, 2011

Menu 19: Updates for March 2011 - May 2011

A lot of interesting news was made over the past few months that I posted online. This update covers the period from March through May of 2011, including extensive coverage of developments from the recent ARVO Meeting held the beginning of May, and several other items.

I would like to start with my coverage of developments announced either just prior to or during the ARVO Meeting.

ARVO Highlights – Synopses and Links:

I have posted several items to my online Journal, based on what I learned was presented at ARVO 2011. Here are a few short briefs of what I’ve put online, along with the links to each posting.

CATT Study Updates

CATT Study Update 13: A First Peek (April 27, 2011)

The day prior to the release of the NEJM writeup about the CATT Study results, Andrew Pollack of the NY Times broke the story after speaking with two of the researchers involved in the study (and who presumably had access to the study results), Pollack basically said that the study will be interpreted in many ways, as some complicating factors may indicate that Lucentis is safer to use than Avastin, but essentially the two drugs showed equivalent results.

CATT Study Update 14: One-Year Study Results Show Equivalency Between Avastin and Lucentis (April 28, 2011)

Probably the biggest news from this year’s ARVO Meeting was the presentation of results of the one-year results of the CATT Study, along with its publication in the NEJM.

In this posting I summarized the results from the NEJM that showed equivalency of Avastin and Lucentis, but with the latter having a 40x larger price tag.

CATT Update 15: Preliminary Two-Year Safety Data Presented at ARVO (May 3, 2011)

During the presentation at ARVO, the study co-authors presented on some of the preliminary safety data that they had collected, but not yet published. This was, perhaps, to refute the charges made by Genentech later in the week that a retrospective study that they had had conducted by a researcher from Johns Hopkins showed that Lucentis was apparently safer than Avastin (surprise!). In the data presented by Drs. Martin and McGovern, there were no major differences in safety.

Other Updates Announced During ARVO:

Iluvien Sustained Release for Treating Diabetic Macula Edema

Iluvien Update 2: New Safety and Efficacy Data Presented at ARVO (May 6, 2011)

Alimera presented on a subset of their FAME Study using Iluvien to treat DME. In this study, the subset data showed that 34% of patients treated with the low dosage of Iluvien that had had DME for three or more years before treatment, gained three lines of vision after therapy.

This subset of data will be provided to the FDA in response to the CRL letter issued by the FDA in December 2010, in response to the New Drug Application filed last summer.

New Results on 2RT for Treating Dry AMD
Ellex 2RT Updated Clinical Results: ARVO 2011 (May 7, 2011)

I have been closely following the exciting news about the Ellex 2RT laser treatment for stopping the progression of dry AMD. Based on the 12-month data presented at ARVO, it appears that we may have a non-invasive treatment that might be able to stop dry AMD in its tracks and prevent the progression into the vision-losing forms of this disease.

And, the Rest of the Recent Postings:

The Development of Femtosecond Lasers for Cataract Surgery (March 27, 2011)

Several years ago, I wrote about my history with intrastromal lasers. That became “Intrastromal Ablation: A Technology Whose Time Has Come?” In that article, I wrote about Automated Laser Systems; its successor, Phoenix Laser Systems; another company working on ISA at the time, Intelligent Surgical Lasers; and, finally, the followup of ISL’s work with picosecond lasers that became the laser development work done at the University of Michigan’s Ultrafast Laser Center, that spawned IntraLase, and its femtosecond (FS) laser.

That is where my history of the development of femtosecond lasers stopped – although I did mention the FS lasers were being developed by Technolas Perfect Vision. Carl Zeiss Meditec, and Ziemer Ophthalmic Systems, and the then startup LenSx, begun by former Intralase founders. In addition, I also wrote about the work being done by Dr. Luis Ruiz, using the Technolas FS laser in treating presbyopia.

Then, recently, Stephen Daily, news editor for CRST, wrote about what happened to the FS laser companies in the several years after my story. His story, “The Origins of Laser Cataract Surgery: Three companies' pathways from development to commercialization” picks up where my story ended.

A Golden Retriever Named Trevor and Retinitis Pigmentosa (April 6, 2011)

Katie McCormick recently learned about a genetic defect in her dog that has its counterpart in humans. The dog defect,  photo receptor cone disease (prcd), associated with progressive retinal atrophy (PRA) is genetically similar to retinitis pigmentosa (RP) in humans. There is extensive research being done on RP, but little on PRA in dogs.

To read about Trevor, a golden retriever diagnosed with PRA as a puppy, and its owners search for a cure, perhaps due to RP research, please see my writeup about Trevor.

Drug Eluting Device Slows Vision Loss in Geographic Atrophy Brought on by Dry AMD

AMD Update 14: Neurotech Pharmaceuticals NT-501 Implant Shown to Slow Vision Loss in Patients with Geographical Atrophy Associated with Dry AMD (April 8, 2011)

A new study, recently published in the Proceedings of the National Academy of Sciences (PNAS) shows that a potential treatment for the advanced stage of dry AMD, geographic atrophy (GA), can be used to slow vision loss in this blinding condition that affects more than a million people.

Neurotech Pharmaceuticals’ NT-501 drug eluting device can be placed in the vitreous of those suffering from GA and will deliver a neuroprotective agent, ciliary neurotrophic factor (CNTF), for up to a year and should result in preservation of vision. NT-501 is not yet FDA approved, as further testing will be required before marketing can occur.

Some Further Updates:
Iluvien Update 3: Alimera Files Resubmission for Approval of Iluvien (May 13, 2011)

Alimera Sciences Inc. filed a resubmission of its New Drug Application (NDA) for the use of Iluvien in treating diabetic macular edema (DME). This resubmission addresses the questions raised in the Complete Response Letter (CRL) received in December 2010. (See Iluvien Update: FDA Marketing Approval Delayed)

Stem Cells in Ophthalmology Update 7: Research Studies with Induced Pluripotent Stem Cells Suggest Opposite Results (May 15, 2011)

Two research studies were recently published about the use of induced pluripotent stem cells (iPSCs) in treating retinal problems, but with opposing results.

In one study, published in Nature, Dr.Yang Xu and his colleagues at the University of California, San Diego, found that iPSCs made from mouse skin cells were rejected by genetically identical mice. (Similar studies with iPSCs, also published in Nature earlier this year, also showed problems, including genetic and epigenectic abnormalities. See Stem Cells in Ophthalmology Update 5: Gene Defects Common in Induced Stem Cells.)

In the second study, Dr. Budd Tucker and his colleagues at the Schepens Eye Research Institute used iPSCs derived from skin to regenerate large areas of damaged retinas and improve visual function in specially  grown degenerative mice. This study was just published in PloS ONE.

Avedro Update: Company Completes U.S. Phase III Study of Microwave Treatment for Progressive  Keratoconus and Ectasia after Refractive Surgery (May 18, 2011)

I have been following the progress of Avedro since I first learned about the formation of the company back in May 2009 (The Rebirth of Thermal Keratoplasty). I then wrote about the company a second time in February 2010 (Avedro Keraflex: Microwaves for Reshaping the Cornea).

Now the company has announced completion of the one-year follow up visits of patients enrolled in its two multi-center Phase III clinical studies, although, not releasing the data as yet, which is undergoing timely analysis.
Oraya IRay Update: Company Completes Enrollment in European Clinical Trial (May 25, 2011)

Since first writing about this company in November 2009 (Oraya IRay In-office Stereotactic X-ray Treatment for AMD: A First Report), I have been following its progress. As I wrote back then, its Phase III Clinical Trial, which planned to enroll approximately 450 patients at 15-20 sites in both the U.S. and Europe, was expected to initiate in mid-2010.

In January, 2010, I learned that the groundbreaking clinical trial, being conducted at seven European sites, and to include a minimum of 150 patients, with approximately one third of those receiving a sham exposure and the remainder receiving radiation dosing of either 16 or 24 Gray (GY), had been initiated.

Now the company has announced that it has completed enrollment in the European arm of the study, as reported in this update. I also asked company officials about the U.S. study arm and the company has responded with some information.

And, Finally, the Completion of my Trilogy About the Discovery of Avastin:

Avastin/Lucentis Update 46: Avastin — The Rest of the Story (April 18, 2011)

Early in April, I came across an important missing piece in the story behind the decision to try Avastin in the treatment of wet AMD. I learned of a story that had been written in November 2006 about how and why Dr. Phil Rosenfeld decided to try Avastin on his patients. I have posted this tidbit as, Avastin/Lucentis Update 46: Avastin — The Rest of the Story. I hope you enjoy this piece of history that might have changed the way that wet AMD is treated forever.


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