FDA Orphan Drug Designation Granted to Profounda Inc. for the treatment of Acanthamoeba Keratitis with miltefosine
Tuesday, December 20, 2016
Profounda, Inc. ("Profounda") announced that it has received the US Food and Drug Administration's (FDA) Orphan Drug Designation for the treatment of Acanthamoeba Keratitis with miltefosine. Profounda licensed miltefosine (Impavido®) from Knight Therapeutics (USA) in September 2015.
Acanthamoeba Keratitis is a rare but serious infection of the eye that can result in permanent visual impairment or blindness. This infection is caused by a microscopic, free-living amoeba (single-celled living organism) called Acanthamoeba. Acanthamoeba causes Acanthamoeba Keratitis when it infects the transparent outer covering of the eye called the cornea. Acanthamoeba amoebas are very common in nature and can be found in bodies of water (for example, lakes and oceans), soil, and air. Acanthamoeba Keratitis is most common in people who wear contact lenses, but anyone can develop the infection. For people who wear contact lenses, certain practices can increase the risk of getting Acanthamoeba Keratitis.
"We are pleased with the FDA's decision to grant orphan drug designation to miltefosine for the treatment of Acanthamoeba Keratitis," said Todd MacLaughlan, CEO of Profounda Inc., "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."
