PORT ELIZABETH OPHTHALMOLOGIST’S

OFF-LABEL INTRAVITREAL INJECTION OF ZALTRAP

You have been advised by your ophthalmologist to have an eye injection of Zaltrap (Ziv-Aflibercept). Zaltrap is an Off-label medication used throughout the world to treat retinal problems. Aflibercept is a next-generation anti-retinal swelling agent with a long duration of action and proven efficacy and safety profile.

It is currently not a first line treatment due to costs, but has proven itself as an excellent agent especially for difficult non-responsive cases.

Zaltrap is registered as a cancer medication. Zaltrap is molecularly almost exactly the same as Eyelea, an FDA approved medication (Also Aflibercept) for retinal problems.

Zaltrap has been used extensively in the developing world over the last 2 years, with good reports on safety and efficacy. The manufacturer does not endorse the medication for eye injections due to the off-label status – meaning it has not passed through rigorous FDA medicine testing.

Laboratory studies on Zaltrap have shown a good safety profile in the eye. Many surgeons are injecting this medication off-label due to vastly improved costs.

Thus far we are not aware of any problems arising from injections with Zaltrap.

As the medication is used off-label, we are obliged to report this to you and ask your permission to inject it should you wish to proceed.

As an alternative, the more commonly used agents such as Lucentis and Avastin is available. Eyelea is the registered FDA approved drug, which is available, but not covered by medical aids in most cases.