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Understanding Ménière's disease

Ménière's disease is a chronic disorder of the inner ear that causes sudden attacks of vertigo, along with hearing loss, tinnitus and a feeling of fullness in the ear. It usually starts in one ear and is linked to a build-up of fluid in the inner ear, known as endolymphatic hydrops.

Ménière's in the US
600K+Americans diagnosed
0FDA-approved treatments

Source: National Institute on Deafness and Other Communication Disorders (NIDCD)

Symptoms

Four symptoms, arriving without warning

Vertigo

Spinning attacks that last from 20 minutes to 12 hours, often with nausea and vomiting.

Hearing loss

Fluctuates early on, usually in the low tones, and can become permanent as the disease progresses.

Tinnitus

Ringing, roaring or buzzing in the affected ear, often louder around an attack.

Fullness

Pressure or a blocked feeling in the ear, sometimes the first sign that an attack is coming.

Based on the diagnostic criteria for Ménière's disease published by the Bárány Society (2015).

Living with Ménière's

A disease you plan your life around

The symptoms are only part of it. Because attacks come without warning, many people with Ménière's reorganize work, travel and family life around the possibility of the next one.

Unpredictable

Attacks can strike at work, while driving or in the middle of the night, with no reliable warning.

Disabling

During an attack most people cannot stand or walk and need to lie still until it passes. Some experience sudden drop attacks and fall.

Isolating

Fear of the next attack leads many people to avoid driving, travel and social plans. Anxiety between episodes is common.

Progressive

Over time, hearing in the affected ear can decline permanently, and the disease can come to affect both ears.

Current treatment

Every option is either off-label or destructive

Treatment usually escalates step by step. When the first options stop controlling vertigo, the remaining ones work by damaging the balance function of the ear, or its hearing.

Conservative

Diet and lifestyle

Low-salt diet and limits on caffeine and alcohol, aimed at reducing fluid build-up.

Conservative

Oral medication

Diuretics and anti-vertigo drugs for attacks. Betahistine, used widely abroad, is not approved in the US.

Off-label

Steroid injections

Steroids injected through the eardrum. Never developed or approved for the ear, and often repeated.

Destructive

Gentamicin injections

An antibiotic injected to destroy balance function in the affected ear, with a risk to hearing.

Destructive

Surgery

Procedures that cut the balance nerve or remove the inner ear's balance organ. Labyrinthectomy ends hearing in that ear.

There is no FDA-approved drug for Ménière's disease. That is the gap Spiral is working to close.

Our approach

Treating the inner ear where the disease is

Spiral is developing SPT-2101, an investigational dexamethasone otic suspension that forms a crosslinked hydrogel at the round window membrane, the entry point to the inner ear. It is placed under direct visualization with MICS™ (Minimally Invasive Cochlear System), by intratympanic administration in the clinic under local anesthesia.

Local

Delivered to the round window membrane, not taken by mouth or injected blind through the eardrum.

Visualized

The MICS Applicator's camera lets the physician see exactly where the formulation is placed.

In clinic

Performed under local anesthesia, with no operating room.

SPT-2101 is investigational and has not been approved by the FDA or any other regulatory authority.