Saturday, October 11, 2008

Lucentis: a New Miracle Drug

Those of us with Macular Degeneration (MD) have wondered when we would lose our useful vision; not if we would, but when, as this is the typical progression of the "wet type" of this disease.

In my particular case, I developed wet MD in 1999 at the age of 70. My father had it and went virtually blind in his mid 70s. Being genetic in origin, I knew I was a prime candidate to develop this disease. Back then, the only treatment was by Laser and after five treatments over a year period my wet MD was arrested but my vision was now 20/400 so I was statutorily blind in the left eye. Fortunately, I retained 20/20 vision in my right eye with no signs of MD on this side.
Fast forward seven years to the fall of 2006. While on a river cruise in Europe, I noticed one day a dimming of vision in my right, good eye on looking at a computer screen. On returning home I immediately contacted my retinologist who confirmed that I indeed had developed wet MD in my right eye. He recommended starting Laser tratment. Like many of us with MD I had kept abreast of research on MD and was familiar with the on-going studies involving both Avastin and Lucentis. On questioning my retinologist I was told that I was not a candidate for any of the new drugs but he could give me no good reason for this conclusion.

Knowing that I would likely lose all useful vision in my right eye, as had happened on the left with the Laser treatment, I opted for a second opinion. Searching Google, I discovered the Casey Eye Institute at the Oregon Health & Science University (OHSU) in Portland, one of the oldest and best eye clinics in the country. Their I met Dr. Andreas Lauer who would become my new retinologist. He explained that their center had been involved in the research studies on Lucentis. It had just been approved for commercial use by the FDA in June 2006 for the treatment of wet MD. They were presently using it almost to the exclusion of any other treatment including the old Laser treatment. He indicated that I would be an excellent candidate for use of Lucentis. I had my first injection of Lucentis into my eyeball that day. The procedure is a little daunting the first time but Dr. Lauer was clearly experienced and the whole procedure from prepping to the end took no more than five minutes. Within a week I noticed that my vision was improving. I returned for a second injection in three weeks and then a third injection four weeks later. By then my vision had returned to 20/20 and I noticed no visual defects on this side. I then skipped a month with no injection but then had two more injections a month apart. Thereafter, there was no evidence of any activity with no swelling of the macula from hemorrhage or edema evident on either the ocular CT scan or on visual examination.
Then another decision had to be made. I could continue to have monthly injections of Lucentis for the rest of my life which would most likely preclude the onset of any further wet MD or I could be followed at 4 - 6 week intervals and have no treatment until further wet MD developed. The Casey Eye Institute is participating in studies that include both protocols. I opted to have no further injections unless the wet MD reappeared. Fortunately, I have now had twelve months of quiescence and have a checkup every six weeks.

My only other treatment has been to take two Preservision capsules (Bausch & Lomb) a day as recommended by Dr. Lauer. This is an antioxidant vitamin (A, C & E) and mineral (Zinc & Copper) supplement that was shown to be clinically effective in the Age Related Eye Disease Study (AREDS) conducted by the National Eye Institute which is a part of the National Institutes of Health (NIH).

Now, a little background on the history of Lucentis. Genentech, a biopharmaceutical company, has been working for several decades on the biochemistry of Vascular Endothelial Growth Factor (VEGF), a normally occurring chemical in the body which initiates and stimulates the growth of blood vessels. It is present in tumors, in particular colon cancer, where it stimulates the growth of the tumor. Genentech developed an anti-vegf drug, Avastin, which has been effective in treating colon cancer by blocking the development of new blood vessels in the tumor.
We know that in wet MD the predominant lesion is the growth of new blood vessels which are fragile and burst causing hemorrhage and edema characteristic of the lesion. The process is caused by a VEGF. In wet MD the treatment is the same as for a tumor: initiate an antii-vegf regimen. Initially Avastin was used successfully in the treatment of wet MD. Genentech then reasoned that a smaller molecule than Avastin might better penetrate the retina and give better results; thus the creation of Lucentis. Avastin is still used by some physicians for the treatment of wet MD. Its big advantage is that it is much cheaper than Lucentis. To date, the results of treatment with either drug look very similar. However, the FDA has not approved the use of Avastin for the treatment of wet MD. Presently studies are underway to determine the efficacy of the two drugs. The Casey Eye Institute is participating in these studies.

The purpose of this blog is to inform readers of the status of research and treatment in the wet type of Macular Degeneration. My retinologist indicated that it may take as long as two years for all physicians in the country to begin using these two drugs. It would be a travesty today if someone became blind for having no knowledge of these new drugs, or worse, if their physician did not make them aware of the existence, avalability and treatment options of these drugs.
One last thought, I have read several blogs indicating that not all insurers will cover the expense of Lucentis. Medicare covers my expense which is $2500 just for the medicine alone. I believe that Avastin is about one-tenth that cost; however, it does not have FDA approval which may influence some insurers. It is my hope that no one will be denied anti-vegf treatment because of cost.

Note: The opinions in this blog are solely those of the author and are not meant as recommendations for treatment. Patients should consult their physician for diagnosis and treatment.

A series of blogs are planned on Atherosclerosis and Coronary Artery Disease.
Macular Degeneration will be updated as new developments occur.

Richard W. Blide, M.D.