Some Israeli soldiers turn out to have developed a weird new hobby. To alleviate the boredom of guard duty, some have taken to removing a bullet from the rifle magazine and using the pointy end to clean their ears.
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The habit may while away the hours but doesn't actually promote otic hygiene, especially if the metal scratches the skin. Battalion doctor Dr. Eran Eilat found himself treating a rash of outer ear infections in the Israel Defense Forces.
As soldiers are not always in a position to lie there stationary for long minutes while the liquid seeps in, rather than down their necks, after administering the drops Eilat would jam wads of cotton into their ears. It was an imperfect solution, sometimes causing pain and, not rarely, falling out.
Thus, Eilat came up with the breakthrough idea behind Otic Pharma: administer the drug in foam form.
By definition, foam expands to fill the ear canal cavity – and it stays put, instead of seeping out.
With medication in foam form, you don't need to lie on your side to administer it, or jam in anything to keep the medicine from dripping out. The foam collapses within an hour, but meanwhile the active ingredient adheres to the ear canal walls.
Since the foam – which is like shaving foam in viscosity and density – stays in the ear canal, lower doses of active medicine could be used, or the medicine could be administered less frequently.
FoamOtic provides significant advantages to the patient and caregiver from compliance and ease of use perspectives, the company says, adding that its foam was tested in various clinical trials for Acute Otitis Externa and found to be safe and efficacious as a single daily dose treatment.
A Phase 3 clinical trial is scheduled for 2015. Otic's foam contains ciprofloxacin, a safe antibiotic that has already won regulatory approval for that use.
The American market for ear medication is $600 million a year, Otic says.
Adaptation for dogs and cats
Dog and cat owners are painfully aware of drug administration problems. First you have to catch the animal, hold its ear firmly with your third hand, drip the drug into its ear, despite its shrieking and struggling, and massage it in – only to watch your dog shake its head vigorously until every last drop is on your silk shirt. Repeat twice a day for a week.
Product development for dogs and cats successfully passed acceptability studies. "We have done tests just to see that the foam doesn't bother them and that the drug stays for days in the ear," says Otic Pharma's research and development VP, Dr. Rodrigo Yelin.
"We're working on a robust foam for animals that remains for a few days," says Yelin, and that's for the good of all. "Treating dogs and cats is very painful to the owner," he understates. "The whole idea is to give the drug once and that's it – 'one and done.'"
Moreover, the foam would be administered once by the vet when he diagnoses the problem, not the owner.
Sounds terrific. Why not develop robust foam for people?
Because foam in their ear might affect their hearing, explains Yelin. He doesn’t spell it out, but your pet isn't about to complain that it can't hear properly, while your son might.
Developing the foam itself for dogs is a future endeavor. They have a huge ear infection problem. The market for ear foam for cats is much smaller: they seem less prone, not to mention the animal is harder to catch. But the company does have a concept ready to roll: for the cat, add treatment for ear mites to the foam. There is a huge need for that.
Another future development is foam for the middle ear, a spot where children especially are prone to infection.
Otic was founded in 2008 in a government incubator. Today it operates out of the Rehovot science park and is supported by venture capital.