The Safety of Avastin, Lucentis, Macugen

There has been concern about the safety of VEGF inhibitors because all three get into the systemic circulation after intraocular injection albeit in very tiny amounts. In addition, the first year MARINA results showed a slightly increased rate of cardiovascular events in the Lucentis groups compared to the sham group. Recent reports however have decreased our concerns:

Joan Miller presented the two-year results of the MARINA Trial at ARVO. There was no difference in mortality among the sham group (6 deaths), the 0.3mg Lucentis dose group (5 deaths), and the 0.5mg Lucentis dose group (6 deaths). There was also no significant difference among the three groups in hypertension, arterial thromboembolic events, or other cardiovascular events.

Fung et al. reported a survey of vitreoretinal experts that included 3,034 patients who had received a total of 3,810 injections of Avastin. The survey showed that only two patients (0.05%) had strokes and that only one patient (0.03%) died. These rates are very low and probably no different than would be found normally in that age-group of patients. A survey can be criticized however because doctors may not want to report that one of his or her patients had a problem. Some patients don’t come back either and unless the doctor called every patient who had Avastin, he or she might be unaware of a problem.

Dave Brown (personal communication) estimates that he and his colleagues have given 1700 doses of Lucentis and haven’t seen systemic complications.

In summary, injections of these agents into the eye probably don’t cause an increased risk of cardiovascular or any other systemic problems but it is still possible that they could cause a very miniscule increased risk. This tiny increased risk would not dissuade me from having an injection that would save or even increase my vision.

References:

1. Patel M, et al. Population pharmacokinetics/pharmacodynamics (PK/PD) of pegaptanib sodium (Macugen®) in patients with age-related macular degeneration (AMD). [ARVO 2006 poster 2623/B782]. Available from http://tinyurl.com/gbqsp, program number 2623. Accessed June 15, 2006.




2. Miller JW, et al. Randomized, controlled phase III study of ranibizumab (Lucentis™) for minimally classic or occult neovascular age-related macular degeneration: two-year safety results of the MARINA study. [ARVO 2006 poster 3539]. Available from http://tinyurl.com/gbqsp, program number 3539. Accessed June 15, 2006.




3. Brown DM. Conference report: Highlights if the Association for Research in Vision and Ophthalmology 2006 Annnual Meeting. AMD Special Report CME Newsletter, volume 4. Available from http://www.medscape.com/viewprogram/5459. Accessed June 15, 2006.




4. Fung AE, et al. Intravitreal Avastin® safety survey: results from the world wide web. [ARVO 2006 poster 5251/B666]. Available from http://tinyurl.com/gbqsp, program number 5251. Accessed June 15, 2006.

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