Santen Receives CRL Letter From FDA for Intravitreal Sirolimus (DE-109)
Published: Dec 21, 2017
EMERYVILLE, Calif., Dec. 21, 2017 /PRNewswire/ -- Santen Pharmaceutical Co., Ltd. (Osaka, Japan) and Santen, Inc. (Emeryville, CA, USA) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) for intravitreal (IVT) sirolimus (DE-109). IVT sirolimus is an investigational therapy developed as a potential treatment for adults with noninfectious uveitis of the posterior segment, a leading cause of preventable blindness in working-age adults.1
The complete response letter indicates that the FDA is unable to approve the application in its present form and requests additional substantiating evidence to demonstrate efficacy of IVT sirolimus in the treatment of noninfectious uveitis of the posterior segment.
"We are evaluating the FDA's response and will work closely with the agency to determine the best path forward. We strongly believe in the benefits of IVT sirolimus for noninfectious uveitis of the posterior segment patients, and will continue to work towards our goal of bringing a local, non-steroidal therapy to patients suffering from this sight-threatening disease," said Naveed Shams, MD, PhD, Chief Scientific Officer and Head of Global Research and Development of Santen. "Santen remains focused on our mission to develop and provide innovative therapies to patients suffering from ophthalmic diseases in the United States and around the world."
The CRL is not expected to have a material impact on FY2017 earnings forecasts.
About Intravitreal (IVT) Sirolimus (DE-109)
About Noninfectious Uveitis of the Posterior Segment
Noninfectious uveitis of the posterior segment constitutes 15 to 22 percent of all cases of uveitis4 and impacts the posterior segment of the eye, including the vitreous, retina, choroid and/or optic nerve.1 Noninfectious uveitis of the posterior segment occurs most often in adults between ages 20 and 50, and affects fewer than 200,000 people in the United States.5
Forward Looking Statements
1 Durrani OM, Tehrani NN, Marr JE, Moradi P, Stavrou P, Murray PI. Degree, duration, and causes of visual loss in uveitis. Br J of Ophthalmol. 2004;88(9):1159-1162.
2 Mikhail M, Sallam A. Novel Intraocular Therapy in Non-infectious Uveitis of the Posterior Segment of the Eye. Med Hypothesis Discov Innov Ophthalmol. 2013 Winter;2(4):113-120.
3 Yeh S, Shantha J. The Burden of Noninfectious Uveitis of The Posterior Segment: A Review. Retina Today. 2016;47-51.
4 Tan HY, Agarwal A, Lee CS, Chhablani J, Gupta V, Khatri M, Nirmal J, Pavesio C, Agrawal R. Management of noninfectious posterior uveitis with intravitreal drug therapy. Clin Ophthalmol. 2016;10:1983-2020.
5 Thorne JE, Suhler E, Skup M, Tari S, Macaulay D, Chao J, Ganguli A. Prevalence of Noninfectious Uveitis in the United States: A Claims-Based Analysis. JAMA Ophthalmol. 2016 Nov 1;134(11):1237-1245.
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SOURCE Santen Inc.