Company Wants To Save Eyesight

By Bob Pepalis www.gwinnettherald.com

An Alpharetta company is ahead of its competitors in a treatment for diabetic macular edema, which causes many patients to lose vision after the onset of diabetes.
"Diabetes is an epidemic in our country, and many countries throughout the world," said Dan Myers, Alimera's president and CEO.After 10 years of diabetes, a patient starts to develop ocular complications, "and the incidents of these complications just grow with time," he said.The macula is the back part of the eye where we see, he said. When the macula swells with fluid it distorts vision.

Alimera developed a treatment called Medidur™ FA to be used via an implant with a simple injection into the retina, something specialists are used to doing. The implant allows a very long treatment time.Alimera has its clinical research on Medidur™ FA at Phase III, the most advanced stage, at more than 100 sites "scattered literally around the world," Myers said.

Almost 1,000 patients were enrolled in the two-year trial. In 2010 the drug will be registered with the Food and Drug Administration in the United States and its counterparts in other countries."We'll get what is called fast-track review. Our expectation is that if it is approved, it would be approved by the end of 2010," Myers said.

Patients who develop diabetic macular edema (DME) lose vision."They lose the ability to see as well as they once could. And so this treatment, the hope is that many patients would have a significant improvement in their vision," he said. Some patients may not improve as much, but it should prevent them from experiencing as big a decline in their eyesight.

Many drugs for eye treatment tend to be delivered via drops, a topical treatment, or monthly injections. Myers said a big market opportunity exists to develop treatment for the back of the eye and for better ways to deliver those drugs. More drugs exists to treat retina disease than anything at the back of the eye."It's becoming a quality of life issue how it delivers. No one wants to come into the office monthly," he said.If Medidur is approved and implemented, the patient may only need to come in every two or three years."We're well ahead of anyone else in the industry with our Phase III trial," he said. "We will be the first drug to be approved by the FDA for the treatment of DME.

Alimera closed a Series C financing round of $30 million with all five of its existing venture capital firms exercising the right to participate at their full pro rata share to enable the company to acquire a majority stake in Medidur™ FA from development partner pSivida Ltd and fund the remaining development obligations for the product."One of the reasons for the $30 million capital raise was to complete the financial transaction that we had with our development partner, pSivida. They were the codeveloper with us on Medidur. They also enjoyed 50/50 profit share when we commercialize the product after FDA approval," Myers said."We were anxious to get more control of development and reduce the split to 80/20. We were willing to pay $12 million to do that," he said.Alimera also has issued a $15 million note (which would accrue interest of up to $6 million over the life of the note) and will make an additional $25 million milestone payment upon FDA approval of the product.