Ear infection? Don't be a drip – use the foam

Gilah Kahn-Hoffman
Israel 21c
April 13, 2010

A promising Israeli startup has whizzed through its paces with a foam-delivery system for eardrops that may revolutionize treatment of a condition that plagues millions.
Anyone who has ever had to squeeze drops into the ear of a squirming child, miserable after the torment of hours of earache, will certainly nod his or her head in agreement with Dr. Gad Riesenfeld when he says: "Parents tell me that eardrops are a nightmare for their children, and it's almost impossible to administer them."Riesenfeld, formerly president of Pharmos Corporation, is chairman of Otic Pharma, an Israeli company that has come up with what it hopes is a brilliantly simple solution to the problem.

Otic Pharma has developed a patented foam formulation technology called FoamOtic that contains antibiotics for treating disorders in the ear canal. The company's foam-based products aim to overcome the disadvantages of eardrops. These include ineffective delivery to the infection site in the ear canal; the way the drops tend to dribble out of the ear; the acrobatics that are all-too-often necessary to deliver them; and the need for the patient to lie down so that the drops can reach the infection.

Otic Pharma also designed a device for foam delivery that is multi-metered and self-cleaning. It resembles a spray bottle with a long, thin flexible tip that is easily inserted into the ear. When you press on the nozzle a single dose of the foam is pushed out, which fills the ear canal. The foam stays within the ear canal, gradually releasing medication all along its length.

Otic Pharma was founded in March 2008 at Peregrine Ventures' Incentive Technological Incubator by Dr. Eran Eilat, the inventor of the technology, Riesenfeld and COO Dr. Rodrigo Yelin, formerly project manager and director of computational genomics at Evogene.

A bullet to the ear

Yelin tells ISRAEL21c that Eilat is both a PhD and an MD who worked as a doctor in the Israel Defense Forces. Eilat found that he was treating numerous ear infections, resulting from bored soldiers' on guard duty inserting whatever was at hand into their ears.

This apparently includes bullets, and it seems that rubbing a bullet along the external ear canal commonly leads to lesions that have a tendency to become infected. To clear up the infection, the patient has to apply eardrops containing antibiotics between two and four times a day.

Since most soldiers can't stop everything, lie down, insert drops and wait for them to slide slowly along their ear canal a few times a day, doctors sometimes used an alternative known as an "ear wick." These are made of absorbent cotton, soaked in a medicated solution and packed into the ear.

The drawbacks: They're painful to insert, they're uncomfortable, they make it hard to hear, it hurts when you take them out and some are embarrassed by their resemblance to a tampon.

However, Eilat noticed that when an ear wick was used, healing occurred faster and pain was reduced sooner. That's what prompted him to come up with the idea of foam, which gradually collapses, slowly releasing medication into the ear, doesn't drain out and feels so non-invasive that within a couple of minutes one doesn't even notice that it's there.

There's no need to lie down, as the foam molds and compresses itself along the ear canal, reaching all the inflamed areas. The company believes it likely that use of foam reduces the number of drug administrations and cures infection faster.

Streamlined strategy means speedy progress

In January, Otic Pharma successfully completed the Phase II clinical trial for its foam-based treatment. On the basis of the Phase II results, it plans to conduct a Phase III trial of its foam-based treatment in 2011.

"Since completing Phase II we have proof that it works," Yelin tells ISRAEL21c. "We tested on 64 adult patients who had Otitis Externa or swimmer's ear. They received either antibiotic treatment in our foam (Foam-Otic Ciprofloxacin) or commercial Ciprofloxacin eardrops. The results obtained clearly showed that the foam is at least as safe and effective as the drops."

The company tried 20 different kinds of foam before settling on the current formulation that doesn't irritate the skin or cause any allergic reactions. In the future, the company plans to develop a combined antibiotics and steroid formula, which is the most common treatment for ear infections.

To date, there has been only one financing round, in which Otic Pharma raised $650,000 - half a million dollars came from the Incentive Incubator supported by the Office of Israel's Chief Scientist and the rest from external investors.

Yelin tells ISRAEL21c that there are a few reasons for Otic Pharma's speedy advance in such a relatively short time. First, because the company used active ingredients that already have Food and Drug Administration (FDA) approval for the medication delivered via the foam, rather than developing a new drug. In addition most tasks are outsourced, which makes the work "fast and efficient."

Foam treatments for pets too

The company's regulatory strategy is to develop its products and seek FDA approval in the US. It believes that this strategy will be acceptable since it does not plan to change drug dosages or delivery sites, but just the delivery mechanism, all of whose components are Generally Recognized as Safe (GRAS) by the US FDA. Patent applications relating to various aspects of the Foam-Otic technology and products have been filed.

Otic Pharma believes that its product line has the potential to capture a significant market share, estimated at $1 billion worldwide. Yelin points out that there is great potential in the veterinary market as well. Dogs, for example, also suffer from ear infections and it is notoriously difficult to treat them.

To that end, the company is also planning to develop Foam-O-Pet. In the next funding round Otic Pharma needs to raise $5 million for the development and registration of its two lead products for the human and veterinary markets, and hopes to be ready for market in 2012.
http://israel21c.org/201004137821/health/ear-infection-dont-be-a-drip-use-the-foam