Choroidal neovascularisation is a potentially visually devastating element of various forms of eye pathology. Recent research has focused on neurovascular age-related macular degeneration (AMD) as a cause. AMD can be classified as being exudative (wet) or atrophic (dry). Wet AMD is characterised by a pathological process in which new bloodvessels develop in the choroids, causing leakage of fluid andhaemorrhage under the retina and leading to localised serousdetachment and loss of central vision. Vascular endothelialgrowth factor (VEGF) stimulates growth of neovascularmembranes. Treatments have until recently yieldeddisappointing results.Ophthalmologists are using intra-ocular injections ofbevacizumab (Avastin), an anti-VEGF, to treat AMD. Avastinappears to be safe and effective in the short term, but its intraocularadministration is entirely off-label. Avastin is registeredfor treating metastatic colorectal and breast cancer.The off-label use of medication is an important partof mainstream, legitimate medical practice worldwide.Lawyers representing plaintiffs injured by drugs increasinglyencounter off-label use claims. From a legal/ethical pointof view the off-label use of medication represents a delicatebalance between the statutory regulation of medication and a physician’s prerogative to prescribe medication that in his or her medical opinion will be beneficial to the patient. The main reason for the controversy created by the off-label use of Avastin is that there are anti-VEGF drugs on the market that have formal approval for the treatment of AMD (and other eye conditions). Lucentis, for example, is extremely expensive, with treatment cost approximately 50 times that of Avastin. Many patients suffering from AMD and macular oedemacannot afford the registered product. The off-label use of Avastin has passed the innovative or experimental stages, as ophthalmologists have used it regularly and openly for a long time, with good success.Such use therefore cannot be considered careless, imprudent or unprofessional. We submit that an ophthalmologist who omits to inform a patient of the availability of Avastin for this form of treatment may be found to be negligent. Protocols developed by the South African Vitreoretinal Society and endorsed by the Ophthalmological Society ofSouth Africa for administering Avastin and other intra-ocular medication intravitreally should be strictly adhered to
