PIER and Torpedoes for Lucentis

The PIER study evaluated whether Lucentis could be injected into the eye less often than once a month and still be effective for the treatment of wet AMD. Treated patients received three monthly injections and then injections every three months at month five, eight, and eleven. After twelve months of follow-up, treated patients had the same vision as they did at baseline whereas the sham treatment group had lost 16.3 letters.(1)

These are good results but not as good as in the MARINA trial in which patients received Lucentis every month. The treated patients in the MARINA trial had a net gain of about one to one and a half lines of vision. Therefore it appears that patients would forfeit this small but significant gain in vision if they followed the dosing schedule used in the PIER study.

Lucentis will probably be approved June 30th and patients do best if they’re injected once a month.(2) So why is it not smooth sailing for Genentech? Retinal experts who are the ones who treat most of the AMD are still a little miffed about the high cost of Visudyne and Macugen. The high cost of those treatments is not Genentech’s fault of course, since Visudyne is sold by Novartis and Macugen by Eyetech. But the retinal doctors are waiting with bated breath to see the price Genentech charges for Lucentis.

Last week was our Iowa Eye Annual Meeting and I asked maybe ten retinal experts from around the country what he or she thought would be the price of a dose of Lucentis. The estimates varied from $400 to $3000 dollars per 0.5mg dose. If Genentech charges a $1000 or less per dose, retinal experts will probably be very happy to use Lucentis and they will use a lot of it. If the cost goes higher, the retinal docs may cause trouble. They may try to use the cheaper Avastin. They may try to give one or two doses of Lucentis followed by a Visudyne treatment using a low total light dose.

In the FOCUS study, patients who were treated with Visudyne plus Lucentis did not do quite as well as those treated in other trials with monthly Lucentis. Many retinal experts now believe however, that Visudyne or PDT can close new blood vessels in AMD even when only a half or even a quarter of the recommend light dose is used.(3,4) The lower light dose will cause fewer side-effects and may have about the same result as monthly Lucentis.

Genentech has tested Lucentis thoroughly, has behaved admirably, and deserves to make a nice profit. The question for them will be whether they want to get all their money back quickly while dodging the torpedoes or will they be content to charge less and have smooth sailing?

References

1. “Preliminary Results from a Phase IIIb Study Showed Patients with Wet AMD Treated with Lucentis Quarterly Experienced a 16-Letter Benefit over the Control Group at One Year.” Genentech Press Release, June 2, 2006. Available from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=9747. Accessed June 19, 2006.




2. “Genentech Granted Six-Month Priority Review for Lucentis for the Treatment of Wet Age-Related Macular Degeneration.” Genentech Press Release, February 28, 2006. Available from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=9427. Accessed June 19, 2006.




3. David Saperstein, MD, University of Washington- Personal Communication




4. David M. Brown, MD, Houston, Texas – Personal Communication