Otonomy OTO-313 — Treatment of Tinnitus

Exactly. People forget that tinnitus is a symptom and not an illness in itself, but the effects it has on a person reflects that of an illness. And so really, I'm looking for a reduction in the symptoms, not complete removal of the core issue as this could take a long time.

 

I couldn't even feel it when they injected me.

 

Ya it’s not that bad at all. I had it done four times for steroids.

 

That's right. For me, the cold anesthetic was more uncomfortable before the injection

 

It’s strange for me to read about your experience. I had three intratympanic injections, and all three times I went unconscious/fainted.

 

From pain or fear?

 

It’s strange to read about your experience.

 

I was a bit nervous, but I remember as soon as the fluid would enter the insides of my ear I’d lose consciousness. But it wasn’t fear/pain. I don’t know why it happened; it may have been a simple reaction that I had.

 

This is a normal reaction to something you think is dangerous. Almost like someone telling you they have to cut off your foot. I would faint

 

I think that resolving tinnitus by restoring hearing function or indirectly by OTO-313 won't lead to silence for me. In my case I have spontaneous acoustic otoemissions in my healthy ear. In the other ear I have tinnitus and the sound difference is quite significant. Spontaneous acoustic otoemissions are such a peaceful sound and make me sleeping easier. It's not common for people to have that, but I have it. Moreover, OAEs are a reflect of the activity of outer hair cells moving, to improve frequency selectivity. It means that more OAEs are louder, the more the ear is healthy. For those who want to see that in details, this scientist explains it very well on this YouTube video link:

The beautiful, mysterious science of how you...

That's my opinion but it sounds quite plausible. Do not confuse with OAE that are caused by microphone, used to diagnosing hearing loss in the newborns.

 

Hopefully this hasn't already been posted : / - new story covering OTO-313:

Tinnitus Study

 

It makes me very sad, every time I hear that a trial is only for recent cases...

 

Intratympanic injection is a 100% pain free procedure and a very safe one. I myself have undergone several ones back when I participated in the AM-101 trial. Doctor first removes any excess wax found in your middle ear, then applies Lidocaine (topical anesthetic) which is left there for around 20 minutes, then the Lidocaine is removed and the injection done. Eardrum tissue is one of the fastest in our body to recover and heal from small wounds.

 

I know, but maybe it will work for long term. They haven’t done too many studies on it yet.

 

Do you have hyperacusis at all? How did they remove the Lidocaine? Microsuction? I probably need to do intratympanic injections anyway.

 

Zero hyperacusis. Microsuction, yes. I can see how that procedure could be somehow harmful for someone with hyperacusis. It lasts a couple of seconds, tho.

 

That's because the most popular theory of tinnitus says that it settles into the brain after a few months. Otonomy is playing it safe. For their Phase I trial they only allowed patients in if they'd had tinnitus for less than 6 months. In Phase I they saw no decrease in effectiveness for patients near the 6 month mark, which is why they opened up the trial to patients who've had tinnitus for up to 1 year for Phase II. If they continue to see no decrease in effectiveness I imagine they'll probably keep expanding the window.

Though then again, I was reading up on minoxidil (Rogaine) and learned that they only ever did studies for the crown of the head. So all Minoxidil products have to legally say it only works for hair loss on the crown (because that's what was tested). However, there are tons of anecdotes online from people who say it works for their hair line and there are communities of people who say it works for beards (with some neat before and after pics). So if Otonomy doesn't expand the window for Phase III, we may be in a situation where there's a drug that possibly works for us but we can't use it because the studies were only done on patients who've had tinnitus for a short time. I hope this doesn't happen and that for Phase III they try the drug on patients who've had tinnitus for a while, but it is a situation we could wind up in.

 

They saw effectiveness in the first trial; that’s why they are on the second.

 

A doctor (at least in the US), is fairly free to prescribe a treatment even if it is outside the clinical trial window. This is why we say they are "practicing medicine." If an ENT were to find out you've had tinnitus for 8 months, but the drug was only FDA approved for 6 months, I think it's highly likely that they would offer to trial treat you and find out if it helps. It's also highly likely, that with FDA approval, more parallel trials will take place to expand the scope of care.

It may still have a window of effectiveness, but we may find out that OTO-313 can be taken by people that already have chronic tinnitus, but are experiencing a spike, where it can mitigate the spike back to baseline more quickly or without additional inflammation/damage.

 

I stumbled across another media report focusing on Dr. Light and OTO-313. It's a different news channel with different patients featured. According to the story, Dr. Light has enrolled around ~20 patients in the study. Obviously he can't say how the trial is going, but the fact that he's reaching out to these media outlets to talk about it (most likely with the aim of raising awareness and recruiting others) is pretty interesting. Hopefully it's a sign that things are going well.

 

Is it true that OTO-313 only works for new patients? I have had tinnitus for 1.5 years. Does it work out for my case?

 

This question will probably only be answered if and when the drug hits the market.

The clinical trials have accepted tinnitus duration of 0-6 months and the latest up to a year.

When on the market you only need to find a willing ENT.

 

There are many people who have experienced tinnitus for a longer time. I hope OTO-313 covers everyone.

 

If someone just gets something to market I think there will be a lot more investments and interest.

 

Yeah! If they are into profits, marketing and revenue, I'd say the long-term sufferers is what it's all about.

Early onset tinnitus clears up with most people if they just take time out and rest their ears, avoiding loud noise and extreme silence.

The acute variety... well great if Otonomy can help those. But I and most here on this forum belong to the accumulated ranks of people whose tinnitus just stays and stays and stays and... and...

 

Otonomy is playing it safe and going by the current theory that tinnitus starts in the ear and then moves to the brain. Their drug treats the ear, so they want to avoid patients with tinnitus originating from their brain. Many people, like myself, don't believe that's how tinnitus really works. However, it's currently the most popular theory.

In their Phase 1 trial, patients who'd had tinnitus for 3-6 months actually improved slightly better than patients who'd had it for 0-3 months. That's why they expanded their current trial out to 1 year. In their latest investor call they talked about how it could be years before tinnitus moves to the brain - no one really knows and there's no hard line indicating when it happens. If this drug makes it to market my guess is it'll work regardless of tinnitus duration - though we won't know until people with longer term tinnitus are treated with it.

Another interesting note - the benefit didn't seem to go away during the time frame they measured (8 weeks). They're measuring for a longer time period this time (4 months). One thing to look for in the Phase 2 data will be if the effect is permanent or if an additional shot is required every few months.

 

I found another piece of media from Dr. Light, this time from his YouTube channel:

A Treatment For Tinnitus Is On The Horizon....

Again it's interesting that he seems so enthusiastic, though I could be reading too much into things. I'm unaware of any other ENTs doing outreach like this. A more cynical take could be that he's simply using this study to promote his business, though I get the feeling that he's just excited to be apart of the study (according to the first YouTube video above he was the first doctor to dose someone for Phase 2).

Anyway, hopefully this outreach helps move the study along quicker. It'd be nice if the end date could be moved up like the OTO-413 end date.

 

I'm actually surprised Otonomy / FDA would be approving of this doctor doing this video. There are specific restrictions on advertising / recruiting for clinical trials. Most importantly, because doing so can affect the outcomes of the trial adversely (ie: Placebo Effect) and patient safety. Obviously, that isn't this doctor's intention, but reading a title like "A Cure for Tinnitus?" is exactly the kind of promoting that gets patients in the mindset to be coerced to produce false outcomes if they join the trial seeking a "Cure."

 

Knowing full well that any of these companies will need clinics to distribute the drug it's possible he has heard anecdotes describing positive results and wants to get a leg up building an SEO presence that will become incredibly saturated if a drug like this is approved and released. We often forget that even if a drug or device is approved - getting it into clinics and training clinicians is no easy feat. The benefit these trial doctors have is knowing how to assess a patient and deliver the goods. It puts them at the front of the line if it's approved and they stand to make outsized returns - at least initially - while the rest of the interested doctors/clinics get trained.

I'm going with positive signal!

 

I really hope that this would be the first drug to treat tinnitus. In my point of view it seems promising.

@Sentinel, I hope you are still getting better? How is your tinnitus lately? Do you see any further improvement?