April 3, 2008
Vitreoretinal Technologies, Inc. Announces the Enrollment of First Patients for Its Phase III Clinical Trial for Vitreosolve for Diabetic Retinopathy Patients in the U.S. And India
IRVINE, Calif., April 3, 2008 (PRIME NEWSWIRE) -- Vitreoretinal Technologies, Inc. (VRT) today announced the enrollment of the first patients in a multinational Phase III clinical trial for evaluation of the safety and efficacy of VRT's investigational drug Vitreosolve(r) for diabetic retinopathy patients. The first patients were enrolled and treated at clinical sites both in the U.S. and India.
Vitreoretinal Technologies (VRT) is a specialty pharmaceutical company with a specific focus on ophthalmology. The company's drug candidates are focused on diabetic retinopathy, glaucoma and retinitis pigmentosa. This study is the first one of two pivotal studies required by the FDA for the application of a New Drug Application (NDA).
"The start of this trial has generated excitement in the ophthalmic community," said Vicken Karageozian, MD, Co-Founder and Chief Technical Officer at VRT. "Diabetes is one of the fastest growing diseases and there are no FDA-approved pharmaceutical treatments for diabetic retinopathy. Retinal specialists recognize the need for new therapies to arrest the progression of this disease."
"We at De Novo Ventures are pleased that VRT has attained this important milestone and we continue to be optimistic about successful completion of these pivotal studies," said Fred Dotzler, Managing Director of De Novo Ventures and Board Member. De Novo is the sole institutional investor in Vitreoretinal Technologies, Inc.
Hampar Karageozian, Founder and Chief Executive Officer of VRT added, "This is a validation of our unique strategy for drug development and management of the regulatory process. Our team should be congratulated for their focus and execution."
Ramgopal Rao, VRT Chief Operating Officer, adds, "We placed emphasis from the beginning on assembling a dedicated management team and experienced group of external consultants, and we look forward to their continued contribution in successful completion of these clinical trials."
It is estimated that there are 8 million diabetic retinopathy patients in the U.S. There is no effective treatment available for arresting or reversing the progression of nonproliferative diabetic eye disease today. Similarly, there are 2 million patients in the U.S. with glaucoma with no neurorescue treatments currently available. VRT drugs address these unmet needs.
VRT has two drug candidates; Vitreosolve(r) for diabetic retinopathy and Neurosolve(r), a neuronal rescue agent for glaucoma and retinitis pigmentosa. Both drugs are small molecules with a long history of safety for systemic use in humans that have been optimized for safety and efficacy in these ophthalmic applications through a series of Phase II trials in humans.
This news release was distributed by PrimeNewswire, www.primenewswire.com
CONTACT: Vitreoretinal Technologies, Inc. Ramgopal Rao, Chief Operating Officer 949-753-1008 Cell: 714 299 9986 [email protected] De Novo Venture Partners Frederick Dotzler, Managing Director 650-329-1999 [email protected]