pSivida Files Early European Regulator for Eye Care Device, Possibly to FDA As Well
Published: Dec 29, 2015
December 29, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Watertown, Mass.-based pSivida Corp. announced yesterday that it plans to file with the European Union (EU) for marketing approval for its Medidur sustained release drug delivery product to treat chronic non-infectious uveitis of the posterior segment of the eye.
Only last week, on Dec. 22, the company announced positive topline results from its sole Phase III clinical trial of Medidur for posterior uveitis. The 129 patient trial showed a positive safety profile and met its primary efficacy endpoint of preventing recurrence of disease at six months.
Medidur is an injectable micro-insert that is injected into the back of the eye. There, it releases a controlled amount of 0.18 milligrams of the corticosteroid flucinolone acetonide directly to the retina for a three-year period. The company is seeking EU approval of the device for the treatment of posterior uveitis. The same device is used as Iluvien for DME, which has been approved in the U.S. and 17 EU countries.
Posterior uveitis is a chronic, non-infectious inflammation of the posterior portion of the eye, often involving the retina. It is the leading cause of blindness in developed and developing countries. In the U.S. it afflicts approximately 175,000 people, and causes about 30,000 cases of blindness.
Standard of care is systemic steroids, but patients often develop serious side effects. At that point, treatment usually shifts to steroid-sparing therapy utilizing systemic immune suppressants or biologics, which increase the risk of cancer and other severe side effects. Medidur, because it focuses the steroids at the site of infection, would have fewer systemic side effects.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) consulted with pSivida, indicating that the results of its recent clinical trial are statistically compelling.
“We are delighted with this advice provided by the MHRA,” said Paul Ashton, president and chief executive officer of pSivida, in a statement. “We expect the high statistical significance of the efficacy data, clinical benefits and positive safety data in our first trial will meet the criteria used by MHRA and other EU regulatory authorities to approve a product on the basis of a single pivotal study. Using data from a single clinical trial would significantly accelerate our filing for EU marketing approval for Medidur. As posterior uveitis affects a similar number of people in the EU and the U.S., accelerated approval in the important EU market would be very beneficial to us.”
The trial data that inspired an early EU application, may also give the company the impetus for early application to the U.S. Food and Drug Administration as well. Current plans are to submit to the FDA in 2017, but with such positive Phase III trial results and a second Phase III already underway, the FDA may agree to an early look.
The company currently hopes to market Medidur by itself in the U.S., but is evaluating potential marketing partners in Europe. Its Iluvien, which treats diabetic macular edema in a very similar fashion as Medidur, is marketed in partnership with Alimera Sciences , headquartered in Alpharetta, Ga.
pSivida took a big jump at the news. Shares traded on Feb. 19 for $4.58, dropped to $3.85 on April 2, and again to $3.49 on July 8. Shares then rose to $4.47 on July 14, dropped again to $3.51 on Dec. 15, and are currently trading fro $4.74.