pSivida expands into orthopedics, eyes FDA ruling

August 19, 2011

By Lori Valigra, Mass High Tech correspondent

Watertown drug-delivery company pSivida Corp. is expanding beyond eye treatments into orthopedics with an evaluation agreement with Hospital for Special Surgery in New York.

Company president and CEO Paul Ashton also said the company expects the U.S. Food and Drug Administration (FDA) to rule on its Iluvien treatment for diabetic macular edema, the leading cause of blindness in diabetics under age 65, by Nov. 12. The company’s partner, Alimera Sciences Inc., resubmitted a new drug application in May.

The agreement with the Hospital for Special Surgery follows pSivida’s announcement in June that it has renegotiated its collaboration with Pfizer to focus on developing a bioerodible sustained release implant for glaucoma and ocular hypertension. 

Ashton said pSivida and the Hospital for Special Surgery will work together to modify existing pSivida hardware. Psivida makes insertable, cylindrical devices that release drugs for extended periods into a specific body region. The collaboration will focus first on placing the devices into the synovial space in joints for treating of osteoarthritis or joint replacements with anti-inflammatory drugs, pain killers, or even hyaluronic acid, but with an initial aim of delaying joint replacement. It will be inserted in conjunction with another surgical procedure.

“The devices concentrate medicine in the exact area where it needs to be, so the systemic levels should be extremely low,” Ashton said. He would not comment on whether there is any money involved in the deal, except to say, “If there’s any money, it’s not material.” Ashton did say, however, that he expects a lot of intellectual property to be generated in the course of the collaboration. Psivida would develop any product generated from the work.

In its Iluvien resubmission, Alimera said it has addressed all issues of concern to the FDA. If Iluvien gets approved by the FDA, it would trigger a $25 million milestone payment from Alimera to pSivida, as well as 20 percent of net profits going forward on sales of the drug.

About one million people suffer from diabetic macular edema in the U.S., Ashton said, and there are currently no approved drugs. Genentech’s Lucentis, already approved to treat macular degeneration, may be approved soon as a competitor to pSivida for diabetic macular edema, Ashton said. The pSivida drug can work for up to 2.5 years after being inserted into the eye, while Lucentis must be injected into the eye monthly, Ashton explained.

He noted there are side effects to Iluvien that the FDA will consider, the two main ones being that it accelerates the development of cataracts and increases eye pressure.

The deal with Pfizer, which involves putting Pfizer’s Xalatan eye drop for glaucoma into pSivida’s device, is in Phase 1,2 trials. Ashton expects to start Phase 2 next year. Psivida will fund the trial until the end of Phase 2, and then Pfizer has the option of assuming all the development and would then pay pSivida $20 million up front plus milestones of up to $146.5 million and double-digit royalties. Or, pSivida could move the drug forward itself, which Ashton said also could be very lucrative.


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