New drug designed to fight macular degeneration awaits FDA approval.
Drug manufacturer Regeneron is in a holding pattern.
Regeneron was hoping to get the green light for a new drug Eylea.
It treats Age-Related Macular Degeneration which is the leading cause of blindness in people over age 60.
There are two kinds of Macular Degeneration: dry and the more common, wet.
Wet AMD is the abnormal growth of tiny blood cells behind the retina that leak fluid, destroying central vision.
Regeneron was hoping for a decision from the FDA last week.
Instead, the FDA said it wants more review time.
The drug takes a few months to create and the process is comparable to brewing beer.
As Dan Van Plew of Regeneron explains, it starts small, in the 500 liter reactor, as the tank is called.
As the cells grow and divide the fluid it pumped to the larger, 3,000 liter reactor and finally to the 10,000 liter reactor.
Once fully grown, the drug is purified.
Then it's ready to be put into treatment syringes.
The drug is administered via injection into the eye.
It only needs to be injected once every eight weeks; a big improvement over drugs already on the market requiring once a month injections
While the FDA advisory panel unanimously recommended approval the full board deferred - extending the review period with a decision now due in November.