Established and up-and-coming treatments for wet age-related macular degeneration (AMD); a controversial announcement by Genentech that the company would stop selling bevacizumab (Avastin) to compounding pharmacies effective Jan. 1, 2008, and the impact this decision would have on patients with wet AMD and other intraocular neovascular diseases; and combination therapies for AMD were topics of high interest to retina specialists in 2007.
In its decision to discontinue sales of bevacizumab to compounding pharmacies, Genentech cited FDA concerns regarding the sterility and repackaging of the drug for ocular use, instead of for its approved use at a higher dose as an intravenous cancer medication, in such pharmacies. Members of the retina community, however, voicing opinions at a forum at the recent American Academy of Ophthalmology annual meeting and elsewhere, view the decision primarily as an effort on the company's part to restrict access to off-label use of bevacizumab and promote the sale of its significantly more expensive anti-vascular endothelial growth factor (VEGF) drug ranibizumab (Lucentis) to treat wet AMD. (Editor's note: For more on this controversy, see "Ophthalmology responds to bevacizumab embargo" on Page 1 of this issue and "Genentech changes distribution channels for bevacizumab" Ophthalmology Times, Nov. 1, 2007.)
Dr. Hughes proposed that the company should issue a letter of apology to physicians.
Sharon Fekrat, MD, FACS, associate professor of ophthalmology, Duke University, Durham, NC, said that large university centers, unlike retina private practices, will be less affected by Genentech's decision because bevacizumab still will be available to university pharmacies that use it to treat patients with cancer.
"Some compounding pharmacists throughout the community may order large quantities of the drug before the cut-off date, so it will be available after Feb. 1, 2008, while retina specialists determine how to obtain bevacizumab for their patients through other means," Dr. Fekrat said.
From a business standpoint, Dr. Hughes hypothesized that perhaps bevacizumab will be sold to another ophthalmic drug manufacturer that has a larger segment of its activity in the field of ophthalmology.
Dr. Fekrat said that, regardless of the availability of bevacizumab, ophthalmologists ultimately will treat their patients with the patients' best interests in mind and ignore the business practices surrounding the drug.