The story doesn’t mention cost at all. Since Lucentis can cost $2,000 per injection, that’s a significant oversight. It would also be useful to tell readers how Lucentis injections compare with the cost of laser treatment. The benefits are, for the most part, reasonably well explained. But those explanations lack numbers to back them up and are overstated in at least one place. “One benefit discussed in the release is that study participants who received laser treatment were more likely to suffer peripheral vision loss than participants who were treated solely with Lucentis — although this isn’t quantified. A second benefit was that participants who received laser treatment were more likely to require subsequent surgery to remove blood from the eye — and this was quantified. But the release pushes things a bit when it comes to vision, or visual acuity. The release states: “At two years, vision in the Lucentis group improved by an average of about half a line on an eye chart, compared with virtually no change in the laser group.” But here’s how the journal article puts it: “There was no statistically significant visual acuity difference between the ranibizumab and PRP [laser] groups at 2 years. The language in the journal article itself stresses that what was being evaluated was whether Lucentis was at least as good as laser treatment — and they found that, after two years, the visual acuity of patients who took Lucentis (and had no laser treatment) was as good as patients who had the laser treatment. The release could have simply stated this and avoided confusion. In short, this was a close one — but the lack of numbers on peripheral vision and the overstatement of the visual acuity results make this a “Not Satisfactory.” The release mentions that one study volunteer in the Lucentis group developed an eye infection and stated that “serious systemic adverse events,” namely cardiac arrest and stroke, occurred at similar rates among the two groups undergoing the two different procedures. We’ll rate that satisfactory for the disclosure although the release might have gone even further by mentioning the other side effects named in the study including inflammation and elevated intraocular pressure which occurred in both treatment groups. The release does a good job of describing the study design, the number of participants, and the fact that this was a randomized clinical trial. A few words about the limitations of the study — e.g. the investigators and patients could not be masked to which treatment they were getting, would have be useful as well. No disease mongering here. The release does tell readers that the study was funded by the National Eye Institute. However, it does not make clear that Lloyd Paul Aiello — who is quoted in the release — was also a co-author of the journal article. The release also fails to mention that several co-authors receive research funding or consulting fees from Genentech, which developed ranibizumab and markets it in the U.S., and Novartis, which markets the drug outside the U.S. The release does a good job of comparing Lucentis to conventional laser treatment for PDR and we’ll award a Satisfactory rating on that basis. However, we’d note that these are not necessarily the only two options. Lucentis is classed as an “anti-VEGF” (anti- vascular endothelial growth factor) drug — by blocking a protein called VEGF, the drug can reverse abnormal blood vessel growth and decrease fluid in the retina. Other drugs in this category include Avastin and Eylea. Are those drugs under consideration for trials related to PDR treatment? If so, it’s worth mentioning — particularly since Avastin costs around $60 per dose, as compared to Lucentis’s $2,000 per dose. The release notes that Lucentis is already used to treat other diabetes-related eye problems, and “should be considered a viable treatment option for people with PDR.” The clinical trial at issue here appears to be the first to look at the use of Lucentis as a treatment for PDR, particularly in a randomized study with direct comparison to laser treatment. However, the release doesn’t tell readers that. On the other hand, the release does make clear that this is the first significant advance in clinical treatment for PDR since the 1970s — that’s good context. The release does a good job of avoiding hype and explaining what was a complex study.
Lucentis Proves Effective Against Proliferative Diabetic Retinopathy