Imagine if no FDA drugs were approved for the discomfort you are experiencing - what would you do? Well, of course, the first thought wouldn’t be to start a company that would cure your disease and help to develop further research on it, would it? But this is exactly what Jay Lichter did back in 2008 by establishing the biopharmaceutical company - Otonomy, Inc.

Being diagnosed with Ménière’s disease, Jay Lichter tried finding a reasonable solution to the hearing loss problem and vertigo he started experiencing. Yet, facing the fact that the FDA hasn’t approved any drugs for treating this disease brought him to find a solution following a different direction.

Lichter has not only treated his condition but also opened a company that is working towards helping people who are also experiencing Ménière’s disease and other hearing problems. This is an entrepreneur’s narrative that might be unheard of, but it is real and has helped many as it is.

Founding Otonomy

Experiencing the discomfort, PhD and scientist Jay Lichter decided that he should establish a company focused on finding a solution to the disease he was struggling with. At first, he started to experience hearing loss and even though it was a noticeable discomfort, Jay Lichter didn’t see it as a burden. That is until he started feeling dizzy while driving his car and had to pull over.

This condition was followed by vertigos occurring every now and then until everyday life started getting difficult for Jay Lichter. Before long, he was diagnosed with Ménière’s disease. Even though his disease was discovered at an early stage, he was informed that there were no FDA-approved products to treat it and that he would have to learn to live with it.

Jay Lichter was shocked by the revelation that there was nothing FDA-approved that could help him. His only options were to either get steroid injections straight to the eardrum or undergo a series of surgeries that may or may not have left him with complete hearing loss. He chose the former option, but that, too, didn’t come without its own drawbacks.

The steroid injections were diluted with water and would easily slip out of his ears, providing him with only temporary relief and limited exposure to the treatment. He would still get vertigos between injections, so it wasn’t a successful or long-term solution.

There must have been something he could do - and there was.

After a while of living with the disease, he had decided that instead of licking the wound with temporary solutions, he should find an answer to his woes and be done for good. He talked with Dr. Jeff Harris about what they could do and how they could improve treatment options and make them more accessible. His background as part of Avalon Ventures also helped trace his path toward a more viable solution.

And thus, they got the idea about Otonomy.

Setting Up the Biopharmaceutical Company

The first step was to form a team of a few neurotologists, starting with the doctor helping him through the illness in the first place, M.D. Ph.D. Jeffrey Harries, who at the time was Chief of the Otolaryngology department at the University of California.

Jay Lichter had many years of experience in biotechnology and pharmaceuticals when he set up Otonomy. Additionally, he was working with Avalon Ventures as an investor. Working among companies whose fund was targeted toward information technology and life-improving research, he knew that establishing this company was the right call.

One of the company's main goals was to change how the inner ear was healed when it came to Ménière's disease. Instead of the many steroid injections one is supposed to get to have their situation improved, Otonomy aimed to change the treatment to heal the inner ear with fewer injections as their priority. And their goal was achieved shortly after.

Before Otonomy's attempt, the drug injected into the inner ear easily exited the ear shell, and its healing effects were gone shortly after - so another injection was required immediately.

Otonomy changed the game by injecting the drug deeply into the inner ear, changing the structure of the cure and using different methods for injecting it. Additionally, the number of doses needed to heal this condition was decreased to one, and the company had successfully achieved what it had aimed for in the first place - to improve the cure for Ménière's disease.

Healing as the Number One Priority

After the successful trials to treat Ménière's disease, Otonomy focused on other hearing problems that people might face. Few more fields of focus have been arrayed on the trial list of Otonomy, and they are continuously being worked on to this day.

Tinnitus is an often experienced disease that occurs in approximately 10% of the adult population in the US. It manifests itself with a constant clicking and ringing in the ear, making everyday life a struggle for people experiencing it. People who served in the military often experience it, yet there are still no FDA-approved drugs for healing it. This is where Otonomy comes to the stage and does its magic.

Acquired hearing loss is something we would all experience at some point in our lives since it comes with age. Genetic hearing loss is not a situation that we could come across very often, but the effects of it on a child's future could be devastating.

Cisplatin-induced hearing loss, or CIHL, is a condition that occurs mostly in children using platinum-based chemotherapy drugs to beat cancer. Still, it can arise in older people fighting cancer as well.

None of these conditions have FDA-approved drugs, and for exactly these reasons, Otonomy strives to make a change.

Finances

Total of 458 million dollars in funding, Otonomy today is supported by 4 lead investors, summing up to an overall of 12 investors from the beginning in 2008 when the company was just being set up.

Well-known companies take place on the list of leading investors, as it is one of the most important contributors for the company since Jay Lichter repurposed its funding to establish Otonomy.

Having 9 funding rounds so far, the last one happened in April 2021 from a Post-IPO Equity round and has raised the company a significant amount of money to continue trials. The main purpose, for now, is to contribute to medicine to the full extent of the investment.

Otonomy Today

Otonomy has over 50 employees and has headquarters in San Diego, California. Striving towards a better future, Otonomy is working on putting further accomplishments on its pipeline, while the previous trials are getting approvals with each day passing by. With some promising funding and plans, success is of no doubt.

The trials in Otonomy are ongoing, and some are getting authorizations from the FDA. The company and its founder promise that new levels will be reached by the end of 2023.