MELBOURNE, AUSTRALIA--(Marketwired - Jul 25, 2016) - Opthea Limited (ASX: OPT) (OTCQX: CKDXY), a developer of novel biologic
therapies for the treatment of eye diseases, will host a conference call at 10:30am Australian Eastern Daylight Time on Tuesday,
July 26 (8:30pm US EDT on Monday, July 25). The Company will discuss results from its Phase 1 dose escalation study of drug
candidate OPT-302 in patients with wet age-related macular degeneration (wet AMD).
To access the live webcast, please visit the Presentations page of the Opthea website at http://www.opthea.com/presentations/. Alternatively, you may access
the live conference call by dialling (888) 576-4387 (U.S.) or (719) 325-2244 (international)
and using conference ID 4334252. An audio archive of the webcast will be available following the call at http://www.opthea.com/presentations/.
About Opthea Limited
Opthea (ASX: OPT) (OTCQX: CKDXY) is a biologics drug developer focusing on ophthalmic disease therapies. It controls exclusive
worldwide rights to a significant intellectual property portfolio around Vascular Endothelial Growth Factor (VEGF)-C, VEGF-D and
VEGFR-3. The applications for the VEGF technology, which functions in regulating blood and lymphatic vessel growth, are
substantial and broad. Opthea's product development programs are focused on developing OPT-302 (formerly VGX-300, soluble
VEGFR-3) for 'back of the eye' disease such as wet age-related macular degeneration (wet AMD).
About Wet AMD
Wet (neovascular) age-related macular degeneration, or wet AMD, is a disease characterised by the loss of vision of the middle
of the visual field caused by degeneration of the central portion of the retina (the macula). Abnormal growth of blood
vessels below the retina, and the leakage of fluid and protein from the vessels, causes retinal degeneration and leads to severe
and rapid loss of vision.
Wet AMD is the leading cause of blindness in the developed world in individuals aged 50 years or older. The prevalence of
AMD is increasing annually as the population ages. Without treatment, wet AMD patients often experience a chronic, rapid decline
in visual acuity and increase in retinal fluid. Sales of the drug Lucentis® (Roche/Novartis), which targets
VEGF-A but not VEGF-C or VEGF-D, were over $US4.5BN in 2015. Sales of EYLEA® (Regeneron/Bayer), which also targets
VEGF-A but not VEGF-C/-D first marketed in November 2011 for the treatment of wet AMD, were over $US2.6BN in
2015. Approximately half of the people receiving Lucentis®/EYLEA® are classified as non-responders or
'poor' responders and do not experience a significant gain in vision and/or have persistent retinal vascular leakage. There is
great opportunity to improve patient responses by targeting more than one factor involved in disease progression. Existing
therapies, such as Lucentis® and EYLEA®, target VEGF-A that promotes blood vessel growth and leakage
through its receptor VEGFR-2. VEGF-C can also induce angiogenesis and vessel leakage through the same receptor as well as
through an independent pathway. Combined inhibition of VEGF-A and VEGF-C/-D, has the potential to improve patient response
by more effective inhibition of the pathways involved in disease progression.
About OPT-302
OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or 'Trap' molecule that blocks the
activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak. OPT-302 is currently being
investigated in a Phase 1/2A clinical trial in wet AMD patients as a monotherapy and in combination with ranibizumab
(Lucentis®). The trial is actively recruiting patients under an FDA approved IND at several US clinical
sites. The purpose of the trial is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of OPT-302
administered as monthly intravitreal injections for 3 months with and without Lucentis® in patients with wet age
related macular degeneration (AMD). The study is being conducted in two parts: Part 1 (Phase 1) comprises an open label,
sequential dose escalation that recruited 20 patients and Part 2 (Phase 2A) a randomized dose expansion that will recruit an
additional ~30 patients and is aimed at further characterising the safety, pharmacokinetic profile and relationship between
dose/PK and clinical activity of OPT-302 (+/- ranibizumab). Further details on the Phase 1/2A trial can be found at: www.clinicaltrials.gov, Clinical trial identifier: NCT02543229.
Inherent risks of Investment in Biotechnology Companies
There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The
lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialisation and a
significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and
proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development,
the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in
technology. Companies such as Opthea are dependent on the success of their research and development projects and on the
ability to attract funding to support these activities. Investment in research and development projects cannot be assessed
on the same fundamentals as trading and manufacturing enterprises. Thus investment in companies specialising in drug
development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought
prior to such investments.
Forward-looking statements
Certain statements in this ASX announcement may contain forward-looking statements regarding Company business and the
therapeutic and commercial potential of its technologies and products in development. Any statement describing Company
goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at-risk
statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties
inherent in the process of developing technology and in the process of discovering, developing and commercialising drugs that can
be proven to be safe and effective for use as human therapeutics, and in the endeavour of building a business around such
products and services. Opthea undertakes no obligation to publicly update any forward-looking statement, whether as a result
of new information, future events, or otherwise. Actual results could differ materially from those discussed in this ASX
announcement.