How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)
Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!
We start this month with AesculaTech, named after Asclepius, the Greek god of healing. This LA-based biomedical startup is developing a thermally responsive hydrogel for treatment of dry eye syndrome. Dry eye syndrome is pretty much what it sounds like: a prolonged absence of adequate lubrication and moisture on the surface of the eye. Symptoms of dry eye include constant eye irritation, stinging, burning or scratchy sensation in the eyes, sensitivity to light, redness and blurred vision or eye fatigue. There are a host of factors that increase your risk of having dry eyes, including prolonged computer use, frequent flying, birth control pills, smoking, contact lens wear, diabetes, arthritis, antihistamines, allergies, and aging. So pretty much “living” can lead to dry eye! A 2012 Gallup poll showed that more than 26 million Americans suffer from dry eyes, and this number is expected to increase to more than 29 million within 10 years.
There are prescription medications as well as over-the-counter (OTC) eye drops currently used for the treatment of dry eye syndrome. Unfortunately, many prescription medications need to be used for a long time before any improvement in the condition is evident, and OTC eye drops (artificial tears) only bring temporary relief and require frequent reapplication.
AesculaTech’s propriety material, the AesculaGel, is unique in that it can achieve three different states of matter. AesculaTech co-founder and chief science officer Niki Bayat refers to the AesculaTech Gel as “Reverse Chocolate” as at low temperatures, the AesculaGel is a liquid. However, as it warms up it turns into a gel, only reaching solid state when it hits body temperature.
To simplify, the liquefied AesculaGel is injected by your doctor into your tear duct which then solidifies as it reaches body temperature. A tiny plug forms that prevents tears from draining away from the surface of the eye. This procedure is intended to be performed during a quick, in-office procedure and last for about a year.
Pre-clinical animal trials using AesculaGel have shown statistically significant increases in tears in the eyes. The company is now preparing for human clinical trials before a pre-market submission to FDA.
According to Aesculatech, AesculaGel is initially being tested for the treatment of dry eye syndrome but there are plans to use the gel for the treatment of glaucoma. According to Bayat and co-founder Andrew Bartynski, AesculaGel has a wide range of potential applications, including pharmaceuticals, medical devices, cosmetics, and textiles. Moreover, since AesculaGel could be used for sustained, localized drug delivery therapies, patient non-compliance to drug regimens to treat chronic conditions could also be potentially addressed.