- Roche did not find any quality problems with the batch of Avastin used in India that had resulted in vision loss for 15 patients, Swissinfo reports. Although indicated for cancer, Avastin is commonly used off-label to treat age-related macular degeneration (AMD).
- Two Indian states, Gujarat and Telangana, halted sales of Avastin in January after the 15 patients were hospitalized. The patients had been treated with the drug for ophthalmic purposes. Roche launched an investigation two weeks later and the alert was later lifted.
- Roche has repeatedly warned Avastin is not approved for the treatment of AMD in India, or in the US and Europe. Furthermore, as Swissinfo reports, the drugmaker cautions against breaking up a dose to treat ophthalmic conditions in multiple patients.
The AMD market in India is growing, and with it, off-label use of Avastin. The Roche cancer drug is significantly cheaper than Novartis' approved AMD med Lucentis, which can cost as much as 40 times the price of Avastin.
Both drugs rely on inhibition of vascular endothelial growth factor, which reduces the growth of new blood vessels. This can help with AMD by limiting abnormal blood vessel growth in the retina.
In addition to warnings from Roche, the Drug Controller of India (DCGI) also released an alert reminding health officials that Avastin is not approved for ophthalmological purposes. Given the cost differences and established practice of using Avastin, the warnings may not curb the off-label practice.
Perhaps recognizing this, the DCGI in March asked the All India Ophthalmological Society and Vitreo Retinal Society of India to formulate guidelines for the safe and effective use of Avastin for ophthalmic purposes.