March 25, 2008
Irvine, California —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® for diabetic retinopathy patients. The first patients were
enrolled and treated at clinical sites both in the US 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 US. 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 US with glaucoma with
no neurorescue treatments currently available. VRT drugs address these unmet needs.
VRT has two drug candidates; Vitreosolve® for diabetic retinopathy and Neurosolve®, 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.
Contacts
Vitreoretinal Technologies, Inc.
Ramgopal Rao
Chief Operating Officer
(949) 753-1008 Office
(714) 299-9986 Mobile
De Novo Ventures
Frederick Dotzler
Managing Director
De Novo Venture Partners
(650) 329-1999
|