A press release put out last month by American pharmaceutical company Adverum Biotechnologies announced some of the long-term preclinical safety data collected about their experimental drug ADVM-022.
The drug hopes to one day be made available to people suffering from wet macular degeneration.
About Macular Degeneration
Age-related macular degeneration (AMD) is one of the leading causes of vision loss in people over 50. The condition’s name refers to the affected part of eye’s anatomy, the macula. The macula is central area of the retina that helps create clear, sharp focus on objects directly in our line of sight.
The retina can be thought of as kind of like a small projector screen on the back of your eyeball. Images projected onto it are then sent along the optic nerve to the brain for interpretation. If the macula, or indeed any other part of the retina, becomes damaged, loss of vision can occur.
In patients with AMD, the macula becomes slowly damaged over time, leading to blurry vision and blind spots.
There are two kinds of macular degeneration – wet and dry. Dry AMD is characterized by the slow deterioration of light-sensitive cells in the macula. Wet AMD is characterized by the formation of new blood vessels behind the retina that can leak fluid into the eye. Wet AMD can progress rapidly and can quickly cause serious damage – unlike dry AMD, which typically presents at a much slower pace.
Drugs with these alphabet soup names are all very early on in their development.
The process of taking a drug through preclinical safety trials all the way to marketing approval can cost dozens of millions of dollars and years of research. As such, only the drugs that seem quite likely to gain approval are slapped with quippy, easy-to-remember names.
ADVM-022 just completed long-term non-human primate safety trials. That means that in its current form (a single intravitreal injection), ADVM-022 presents no clear risk to the health of primates. It’s an important step before evaluating safety and efficacy in humans, but it’s also very early along the course of development.
Most drugs, it should also be noted, do not pass clinical trial. An estimate from MIT published last year estimated that only 14% of drugs ever win approval from the FDA – which was actually a much higher figure than had been expected.
ADVM-022 is now undergoing phase 1 trials designed to determine any possible side effects, and overall safety for human use. That means that even if ADVM-022 does improve the condition of wet AMD patients, it could be several years before it enters the market in the United States. And that’s a big “if.”
Drug companies like to keep their names in the public eye. It’s a savvy business strategy in a multi-billion dollar industry when differentiation can be the difference between fortune and ruin. As such, it’s no surprise that companies like Adverum publish press releases for their products so early along their development. A lot of the pharmaceutical game is brand recognition – companies will often publish every forward step of a drug’s trip through clinical trials, no matter how small that step may be.
If ADVM-022 ever does make it to market, it would be a huge breakthrough for elderly sight loss. However, that day is likely to be much, much further away than Adverum would like you to think.
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