Blind World

Company pioneering eye disease treatments.

August 29, 2004.

Staff Reporter,
The Mobile Register.

Seven years ago, Dr. Eugene de Juan Jr. started developing a tiny coil device, roughly half the size of an aspirin, that is screwed into the eye. The coil is coated with medication and used to treat especially difficult eye disease.

That and other inventions by de Juan, a graduate of the University of South Alabama medical school, spawned the formation of a Mobile-based company that's developing cutting-edge treatments for conditions that lead to vision loss and blindness.

The business, InnoRx, is flush with a $3.5 million investment from a Minnesota company and is set to begin human trials later this year on its helical coil.

InnoRx is developing several products for diseases that affect the retina, an area of the eye for which limited treatment options are available.

"This is a company that is taking an aggressive approach to back-of-the-eye disease," said Dr. Eliot Lazar, a Buffalo, N.Y., opthamologist who analyzes medical devices and technologies for banks, investment firms and other organizations.

InnoRx referred the Mobile Register to Lazar, who said he has studied the company but has no financial stake in it. Lazar called InnoRx a "young, fresh company" that will "provide enormous value to patients and doctors."

De Juan, who founded InnoRx in 1999, is chief executive officer of the Doheny Retina Institute, which is affiliated with the University of Southern California.

InnoRx is a family affair: The business initially was funded by family members, who still control the majority interest, and Michael Chambers, de Juan's brother-in-law, serves as president and chief executive officer and operates the company from Mobile.

"I think they will revolutionize the market," said Bruce Barclay, president of SurModics, the Minnesota company that invested in InnoRx.

InnoRx is focusing its efforts on treating age-related macular degeneration and diabetic retinopathy, which together affect more than 15 million people nationwide, according to medical organizations.

The former occurs when the macula -- the area in the retina at the back of the eye which allows people to see fine detail clearly -- deteriorates, according to the American Academy of Opthamology.

Diabetic retinopathy, caused when high blood-sugar levels damage blood vessels in the retina, is the most common diabetic eye disease, affecting between 40 and 45 percent of those with diagnosed diabetes, the National Eye Institute reports.

Both conditions affect the back of the eye, an area difficult to reach with medication, de Juan said. Eye drops often are washed away before they reach the retina.

Emerging treatments include implantable devices, but those differ from the helical coil because they either require surgery and stitches or do not deliver medication for as long a period.

Other methods involve injecting medication into the eye every four or six weeks. Neither the implantable devices nor the injections have been approved by the federal Food and Drug Administration, Lazar said.

By comparison, according to InnoRx, the helical coil offers several "competitive advantages:" delivery of medication for over a year, elimination of the need for multiple injections, lower risk of toxicity and ability to remove the device if necessary.

De Juan said other systems are much more invasive and thus carry more risk, take longer and cost more.

InnoRx's 5-millimeter coil is inserted into the eye through a needlestick that punctures that portion of the eye to make a hole, during a procedure that takes between eight and 10 minutes, Chambers said. The coil is designed to be implanted on an outpatient basis.

Chambers said InnoRx plans to initially seek FDA approval to market its helical coil for diabetic macular edema, a swelling or thickening of the macula which results from diabetic retinopathy.

A Phase I clinical trial, which involves first-time testing of the treatment in humans, is scheduled to begin in December and likely will take place in southern California, Chambers said.

If all goes well, the product likely will reach the market by 2008 or 2009.

De Juan, who graduated from USA's College of Medicine in 1979, was on the medical staff at Duke University Eye Center for nine years and spent another nine years at the Wilmer Eye Institute at Johns Hopkins University School of Medicine before going to USC.

While at Johns Hopkins, the physician -- along with a team -- invented several devices now being developed by InnoRx. The Mobile company licensed the systems from Johns Hopkins.

Chambers said the market focus of treatment has moved away from oral medications to so-called drug delivery systems, such as the helical coil.

He compared the human body to a football field, saying the eyeball is like a 50-cent piece on the 50-yard line. To take a drug orally, he said, is like watering the whole field just to tend a minute area.

Lazar, the medical device and technology analyst, said there are about 200 drug delivery systems in the primitive stages of development but none have progressed as far as InnoRx's coil.

Lazar said the field is flourishing for a few reasons: the number of cases of blinding disease is expected to increase significantly as the large Baby Boom generation ages, carrying a socioeconomic impact; and it's an "extraordinarily lucrative market" because of the unmet need.

"Although 55 percent of all debilitating eye diseases and conditions occur in the back of the eye, it is estimated that less than 5 percent of ophthalmic pharmaceutical sales are derived from drugs designed to treat these disorders," InnoRx reports. "Some analysts predict this market will be $4 billion to $5 billion within the next decade."

In addition to investing in InnoRx, SurModics plays another role.

InnoRx has an exclusive license from the Minnesota company for its coating technology, to be used to apply medication to the helical coil, so the drug will be released slowly, over time.

Barclay, the president of SurModics, said as his company learned about InnoRx's products, "the more excited we became about working with them." SurModics then became an investor because "we liked the company so well."

In addition to its helical coil, InnoRx is focusing its efforts on another product, a subretinal drug delivery system, which is currently being tested in animals.

A retinal barrier in the eye protects it but also prevents some drugs from getting in. The helical coil will be in front of that barrier, according to Chambers, but the subretinal system would deliver the drug behind the barrier.

It would be "immediately taking the drug to exactly where it's needed," Chambers said.

The subretinal system uses small implantable filaments, which also would be coated with medication using SurModics' technology.

The system is about a year behind the development of the coil, Chambers said.

InnoRx has several other products under development, including a subretinal injector and orally administered medications and vitamins.

The company plans to open an office in southern California within the next three to four months, Chambers said.

He added that InnoRx is a small company, but with de Juan's expertise, "we're on the cutting edge of a very important development in opthamology."

End of article.

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