River Vision Announces Receipt of Breakthrough Designation from US FDA
TED is a rare condition suffered by a proportion of Graves’ Disease patients. Characterized by inflammation and a build up of tissue behind the eye, the disease causes the eyeball to protrude from the socket. This can change the patient’s appearance and result in orbital pain, corneal ulceration, optic neuropathy and double vision among other serious effects. There is no approved medical therapy for the treatment of TED. Patients in need of immediate relief of pressure on the optic nerve, or reconstruction following the resolution of active TED, are often treated by orbital surgeries to restore function and appearance.
The Breakthrough Therapy Designation is based on the results of River Vision’s TED01RV trial of RV001 in patients with moderate to severe active TED. “The receipt of Breakthrough Therapy Designation is an important step in the process of getting this novel therapy to patients as quickly as possible,” said Guido Magni, Chief Medical Officer of RVDC. “Moderate to severe TED is a painful and debilitating condition that can impair activities of daily living and diminish quality of life. It can also cause a marked change in appearance that is distressing for patients.”
The FDA had previously granted Fast Track designation and Orphan Designation for the product.
About River Vision Development Corp.
River Vision Development Corp. was founded by Narrow River Management, LP (Narrow River) for the sole purpose of developing teprotumumab for GO and other potential indications. The Company is managed under contract with Narrow River, which provides leadership expertise for special purpose drug development companies. The Company’s investors include SROne, Lundbeckfonden Ventures and Narrow River Management, LP.