BUSINESS WIRE
Adenosine A2a receptor agonist; new mechanism of action not seen in conventional glaucoma medications SEATTLE & TOKYO, Sep 13, 2011 (BUSINESS WIRE) --
Acucela Inc., a clinical-stage biotechnology company focused on
developing new treatments for blinding eye diseases, and Otsuka
Pharmaceutical Co., Ltd., today announced the initiation of a Phase 1/2
clinical trial for OPA-6566. OPA-6566, an adenosine A2a receptor
agonist, is being developed as an ophthalmic solution to reduce
intraocular pressure in open-angle glaucoma (OAG) or ocular hypertension
patients. OPA-6566 was discovered by Otsuka.
The compound offers a new mechanism of action not seen in conventional
glaucoma medications, and has demonstrated the ability to lower
intraocular pressure by stimulating aqueous humor outflow via trabecular
meshwork by activation of the adenosine A2a receptor.
Glaucoma is a type of progressive or chronic optic neuropathy caused by
factors of unknown origin but generally associated with elevated
intraocular pressure. Persons affected with glaucoma experience gradual
loss of vision over a long period of time. As lost vision cannot be
recovered, continuous control of intraocular pressure is necessary for
the rest of the patient's life. For this reason, safe drugs that lower
intraocular pressure are needed.
Estimates projected that in 2010 there would be 60.5 million people with
OAG and angle closure glaucoma (ACG), and that number was expected to
increase to 79.6 million by 2020. Bilateral blindness was expected to be
present in approximately 4.5 million people with OAG and 3.9 million
people with ACG in 2010, and was expected to rise to 5.9 and 5.3 million
people in 2020, respectively.(1)
"We believe the demand for better glaucoma treatments is great; and we
are excited to advance this compound to the clinical stage just one year
after signing our agreement with Otsuka Pharmaceutical," said Ryo
Kubota, M.D., Ph.D., chairman, president, and chief executive officer,
Acucela Inc. "Today's announcement is in line with our strategy to
develop leading-edge therapies for blinding eye diseases."
About the OPA-6566 Phase 1/2 Clinical Trial
The trial will be conducted at clinical sites in the United States in
patients with open-angle glaucoma or ocular hypertension and will test
for safety, tolerability and the IOP-lowering effects of OPA-6566. The
trial is designed as a first-in-human, randomized, multi-center,
investigator-masked, placebo- and active-controlled, dose-escalation
study with 28 days of treatment in patients with open-angle glaucoma or
ocular hypertension.
About the Otsuka Pharmaceutical/Acucela OPA-6566 Agreement
Under the September 2010 agreement, Otsuka will contract Acucela to
perform early clinical development of OPA-6566 in the United States and
will grant Acucela an opt-in right to co-develop and co-promote the
compound. In the event and after Acucela exercises the opt-in right,
Otsuka and Acucela will co-develop the compound, share the cost
incurred, and co-promote the resulted product in the United States after
regulatory approval. Upon Acucela exercising its opt-in right, Otsuka
will receive a pre-determined opt-in fee and milestone payments.
About Acucela Inc.
Acucela Inc. (
www.acucela.com )
is a clinical-stage biotechnology company focused on leveraging
promising science in visual cycle modulation (VCM) to develop new
methods for treating blinding eye diseases that affect tens of millions
of people worldwide. The Company's orally delivered VCM compounds, which
selectively target cells within the retina to protect visual acuity,
have the potential to treat several devastating eye diseases, including
dry AMD, for which there is currently no treatment options, retinopathy
of prematurity, Stargardt disease and diabetic retinopathy. ACU-4429 for
dry AMD is being co-developed by Acucela and Otsuka Pharmaceutical Co.,
Ltd. in North America, and the companies are also co-developing
rebamipide for dry eye and OPA-6566 for glaucoma in the United States.
Acucela was founded by Ryo Kubota, M.D., Ph.D., a pioneer in
ophthalmology and the discoverer of the gene that causes glaucoma.
About Otsuka Pharmaceutical
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare
company with the corporate philosophy: 'Otsuka-people creating new
products for better health worldwide.' Otsuka researches, develops,
manufactures and markets innovative and original products, with a focus
on pharmaceutical products for the treatment of diseases and consumer
products for the maintenance of everyday health. Otsuka is committed to
being a corporation that creates global value, adhering to the high
ethical standards required of a company involved in human health and
life, maintaining a dynamic corporate culture, and working in harmony
with local communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka
Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka
Group has business operations in 23 countries and regions around the
world, with consolidated sales of JPY 1,090.2 billion for fiscal year 2010.
(1) The number of people with glaucoma worldwide in 2010 and
2020, HA Quigley, AT Broman Br J Ophthalmology 2006; 90:262--267.