FDA grants Orphan Drug Designation to miltefosine

Acanthamoeba Keratitis is more likely to affect people who wear contact lenses. | File photo

Profounda's miltefosine has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of Acanthamoeba Keratitis.

Profounda received the rights for miltefosine in 2015 from Knight Therapeutics.

"We are pleased with the FDA's decision to grant orphan drug designation to miltefosine for the treatment of Acanthamoeba Keratitis," Profounda CEO Todd MacLaughlan said. "By creating miltefosine-induced alterations to the membrane architecture of the amoeba, miltefosine allows patients a therapeutic option that has potential advantages over conventional therapy approaches."

Acanthamoeba Keratitis is a rare infection of the eye, but is very serious. It can lead to permanent visual impairment or even blindness if left untreated. The infection is a result of microscopic, amoeba that is free-living known by the name Acanthamoeba. When Acanthamoeba infects the cornea, the result is Acanthamoeba Keratitis. This type of amoeba is very common in nature and is normally found in bodies of water, including lakes, oceans, etc., soil and in the air.

Acanthamoeba Keratitis is more likely to affect people who wear contact lenses. However, anyone can get the infection.

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Profounda, Inc. 5790 Hoffner Ave Orlando, FL 32822-4824