Alimera, pSivida eye implant finally wins U.S. approval

[September 27, 2014]  By Vidya L Nathan and Anjali Rao Koppala

(Reuters) - Alimera Sciences Inc and pSivida Corp said the U.S. Food and Drug Administration approved their vision-loss treatment Iluvien, following three rejections.

Alimera's shares jumped about 16 percent to $5.95, while pSivida rose about 10.5 percent to $4.73 in extended trading.

Iluvien will treat a condition known as diabetic macular edema (DME), a swelling on the back of the retina that in the most severe cases can lead to blindness.

Iluvien, which will compete with Regeneron Pharmaceuticals Inc's Eylea and Roche AG's Lucentis, is expected to be available in the United States in early 2015.

"The FDA's approval of Iluvien is not limited, as in the EU, to the subset of patients with chronic DME, patients who have failed other therapies, or patients who have had cataract surgery," pSivida CEO Paul Ashton said in a statement on Friday.

The company licensed the implant to Alimera in February 2005 and will receive a milestone payment of $25 million following the approval.

PSivida is also entitled to get 20 percent of the profits from U.S. sales.

Iluvien, already available in the UK and Germany, is an injectable implant. The treatment involves positioning a tiny, cylindrical tube containing a drug in the back of the eye — the spot where DME typically forms.

A single injection of Iluvien provides sustained treatment of DME for 36 months, compared to standard treatments that need to be administered as frequently as monthly, pSivida said.

Eylea, which also needs to be injected into the eye, received expanded approval for DME on July 29. The drug generated sales of $415 million in its latest quarter.

DME is the primary cause of visual impairment in diabetic retinopathy, the most common diabetic eye disease and a leading cause of blindness in American adults.

About 560,000 people in the United States are estimated to have clinically significant DME, pSivida said.

In the past, Iluvien was rejected citing safety concerns and FDA also highlighted deficiencies at the facility where the drug is manufactured.

The latest rejection came in October 2013, when the U.S. health regulator suggested a new trial with at least 12 months of follow-up for all enrolled patients in that trial.

Alimera is also testing Iluvien to treat dry age-related macular degeneration.

(Reporting by Vidya L Nathan and Anjali Rao Koppala in Bangalore; Editing by Simon Jennings and Sriraj Kalluvila)

[© 2014 Thomson Reuters. All rights reserved.]

Copyright 2014 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.