Acucela Signs Agreement to Develop a Compact OCT for NASA’s Deep Space Missions

SEATTLE–(BUSINESS WIRE)–Acucela Inc. (“Acucela”), a clinical-stage ophthalmology company and
wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd.
(Tokyo 4596), announced today that the company signed the agreement with
the Translational Research Institute for Space Health (TRISH) to develop
a compact OCT^*1 device for NASA’s Deep Space missions.

Approximately 63% of long-duration spaceflight crewmembers present with
one or more signs of Spaceflight Associated Neuro-ocular Syndrome
(SANS), including optic disc edema, globe flattening, choroidal folds,
cotton wool spots, and refractive shifts. OCT has become a mainstay of
crew testing for SANS because it allows accurate measurement of retinal
thickness and cross-sectional imagery of the retina and optic disc. This
in combination with other tests provides the necessary data to diagnose,
monitor, and eventually treat SANS.

The commercially available off-the-shelf (COTS) OCT devices currently
deployed to the International Space Station (ISS) are not suitable for
Lunar, Martian and other expeditionary space travel. These commercial
systems are complex, too large, not radiation hardened, and contain
features that are not necessary for diagnosing and monitoring the
anatomic effects of SANS.

By using a unique approach, we are able to create a solid-state OCT
yielding high resolution imagery. The final flight-ready device will
allow NASA to replace current COTS OCT devices with smaller, lighter,
easier to use, durable and radiation hardened instruments that are
practical for use in smaller spacecrafts, while providing required image
quality from astronauts during flight.

Ryo Kubota, a visiting professor at Keio University School of Medicine,
MD, PhD, and Chairman, President and CEO of Acucela stated, “I am very
excited to be able to take part in NASA’s efforts as a principal
investigator with expeditionary space travel. Using our technology, we
will endeavor to build a durable, hand-held OCT device for use during
space flight, to help safeguard crewmembers’ health.”

About Acucela Inc.

Acucela Inc. is a wholly-owned subsidiary of Kubota Pharmaceutical
Holdings Co., Ltd. (Tokyo 4596) committed to translating innovation into
a diverse portfolio of drugs and devices to preserve and restore vision
for millions of people worldwide. Acucela’s development pipeline include
drug candidates for the treatment of diabetic retinopathy, diabetic
macular edema, Stargardt disease, age-related macular degeneration,
cataracts and presbyopia, and, optogenetics-based gene therapy for the
treatment of retinitis pigmentosa. The company is also developing a
handheld OCT device for the monitoring of neovascular retinal diseases,
to be used directly by patients. http://www.acucela.com;
http://www.kubotaholdings.co.jp/en/

About the Translational Research Institute for Space Health

Partnering with the NASA Human Research Program through a cooperative
agreement, the Translational Research Institute for Space Health (TRISH)
funds transformative human health technologies to predict, protect, and
preserve astronaut physical and mental health during deep space
exploration missions. The institute is a consortium led by Baylor
College of Medicine and includes the California Institute of Technology
and the Massachusetts Institute of Technology. www.bcm.edu/spacehealth

Cautionary Statements

Certain statements contained in this press release are forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995. Any statements
contained in this press release that are not statements of historical
fact may be deemed to be forward-looking statements. These
forward-looking statements include statements regarding our expectations
related to our development plans and ability to successfully develop and
commercialize our product candidates and the potential efficacy, future
development plans and commercial potential of our product candidates.
These statements are based on current assumptions that involve risks,
uncertainties and other factors that could cause the actual results,
events or developments to differ materially from those expressed or
implied by such forward-looking statements. These risks and
uncertainties, many of which are beyond our control, include, but are
not limited to: our investigational product candidates may not
demonstrate the expected safety and efficacy; our pre-clinical
development efforts may not yield additional product candidates; any of
our or our collaborators’ product candidates may fail in development,
may not receive required regulatory approvals, or may be delayed to a
point where they are not commercially viable; our clinical trials could
be delayed; new developments in the intensely competitive ophthalmic
pharmaceutical market may require changes in our clinical trial plans or
limit the potential benefits of our investigational product candidates;
the impact of expanded product development and clinical activities on
operating expenses; adverse conditions in the general domestic and
global economic markets; as well as the other risks identified in our
filings with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date hereof and we
assume no obligation to update these forward-looking statements, and
readers are cautioned not to place undue reliance on such
forward-looking statements. For a detailed discussion of the foregoing
risks and other risk factors, please refer to our filings with the
Securities and Exchange Commission, which are available on Kubota
Pharmaceutical Holdings (Acucela’s parent company) investor relations
website (http://www.kubotaholdings.co.jp/en/ir/)
and on the SEC’s website (http://www.sec.gov).

“Acucela”, the Acucela logo and “Kubota” are registered trademarks or
trademarks of Acucela Inc. or Kubota Pharmaceutical Holdings in various
jurisdictions.

Contacts

Media and Investor Relations:
Hiroki Maekawa
Chief Financial
Officer
Phone: +81-3-6550-8928
Email: [email protected]