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<h2>Opthea Limited</h2>
<h3>Eyeing the global opportunity in retinal diseases</h3>
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<p>Opthea Ltd (ASX:OPT) is a clinical-stage biotechnology company focused on developing and commercialising therapies to treat progressive retinal diseases including wet age-related macular degeneration (Wet AMD) and diabetic macular edema (DME). The company’s leading product candidate is OPT-302 which is in Phase III clinical trials for Wet AMD and is being developed for use in combination with anti- Vascular Endothelial Growth Factor-A (VEGF-A) monotherapies to achieve broader inhibition of the VEGF family. Opthea has also completed a Phase IIa clinical trial in patients with persistent DME. Opthea is listed on both the ASX and NASDAQ. The company was previously called Circadian Technologies, which listed on the ASX in 1985, making it one of Australia’s oldest listed biotechs. Opthea listed on NASDAQ in October 2020, after raising US$128.2m in gross proceeds at an IPO price of US$13.50 per American Depository Share (ADS). The stock is currently trading at US$4.73 per ADS or at a ratio of eight ordinary shares to one ADS.</p>
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<h3>Business model</h3>
<p>Opthea is focused on developing its lead product OPT-302 to better optimise visual outcomes for patients with Wet AMD and DME. Wet AMD is the leading cause of blindness in the developed world in people over the age of 50 years and is caused by leakage of blood vessels at the back of the eye which causes degeneration of the retina and vision loss. DME is caused by a complication of diabetes called diabetic retinopathy which is the most common diabetic eye disease and the leading cause of blindness in diabetics. Current standard-of-care treatments for Wet AMD and DME share the common mechanism of inhibiting VEGF-A. The market-leading VEGF-A inhibitors approved for the treatment of Wet AMD and DME, Lucentis (ranibizumab) and Eylea (aflibercept), had worldwide sales of more than US$12b in 2021. While these have achieved widespread adoption, many patients experience suboptimal clinical responses with the majority of patients failing to achieve 20/40 vision after 12 months’ treatment. OPT-302 is an inhibitor of VEGF-C and VEGF-D and is being developed for use in combination with a VEGF-A inhibitor to block the signalling pathways that contribute to retinal diseases. OPT-302 is administered by intra-vitreal injection into the eye, which is the same route of administration of approved standard-of- care treatments for Wet AMD.</p>
<h3>Phase III programme the key focus over 2022 and 2023</h3>
<p>Opthea’s Phase III programme consists of two concurrent, global, randomized, sham- controlled studies enrolling approximately 990 patients across more than 20 countries in each trial. The primary end-point in both trials is mean change to visual acuity from base- line to week 52 for OPT-302 and anti-VEGF-A combination therapy compared with anti- VEGF-A monotherapy on its own. Following completion of the primary efficacy phase of the trials, Opthea intends to submit biologics license and marketing authorisation applications with the FDA and EMA respectively.</p>
<h3>Look to biotechs conducting Phase III trials as peers</h3>
<p>There are few Australian-listed biotechs which can be considered direct peers to Opthea. We look to biotechs such as Dimerix (ASX:DXB), Neuren Pharmaceuticals (ASX:NEU) and Telix Pharmaceuticals (ASX:TLX) as peers given they are all conducting Phase III trials. The US market yields more comparable peers both from the stage in their pipeline and disease targets. NASDAQ-listed peers include Kodiak (NASDAQ:KOD), which is also in late-stage trials for its Wet AMD and DME targets amongst other diseases; and Outlook Therapeutics (NASDAQ:OTLK), which is in Phase III trials on its therapies for Wet AMD.</p>
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Opthea Limited
Eyeing the global opportunity in retinal diseases





Opthea Ltd (ASX:OPT) is a clinical-stage biotechnology company focused on developing and commercialising therapies to treat progressive retinal diseases including wet age-related macular degeneration (Wet AMD) and diabetic macular edema (DME). The company’s leading product candidate is OPT-302 which is in Phase III clinical trials for Wet AMD and is being developed for use in combination with anti- Vascular Endothelial Growth Factor-A (VEGF-A) monotherapies to achieve broader inhibition of the VEGF family. Opthea has also completed a Phase IIa clinical trial in patients with persistent DME. Opthea is listed on both the ASX and NASDAQ. The company was previously called Circadian Technologies, which listed on the ASX in 1985, making it one of Australia’s oldest listed biotechs. Opthea listed on NASDAQ in October 2020, after raising US$128.2m in gross proceeds at an IPO price of US$13.50 per American Depository Share (ADS). The stock is currently trading at US$4.73 per ADS or at a ratio of eight ordinary shares to one ADS.





Business model
Opthea is focused on developing its lead product OPT-302 to better optimise visual outcomes for patients with Wet AMD and DME. Wet AMD is the leading cause of blindness in the developed world in people over the age of 50 years and is caused by leakage of blood vessels at the back of the eye which causes degeneration of the retina and vision loss. DME is caused by a complication of diabetes called diabetic retinopathy which is the most common diabetic eye disease and the leading cause of blindness in diabetics. Current standard-of-care treatments for Wet AMD and DME share the common mechanism of inhibiting VEGF-A. The market-leading VEGF-A inhibitors approved for the treatment of Wet AMD and DME, Lucentis (ranibizumab) and Eylea (aflibercept), had worldwide sales of more than US$12b in 2021. While these have achieved widespread adoption, many patients experience suboptimal clinical responses with the majority of patients failing to achieve 20/40 vision after 12 months’ treatment. OPT-302 is an inhibitor of VEGF-C and VEGF-D and is being developed for use in combination with a VEGF-A inhibitor to block the signalling pathways that contribute to retinal diseases. OPT-302 is administered by intra-vitreal injection into the eye, which is the same route of administration of approved standard-of- care treatments for Wet AMD.
Phase III programme the key focus over 2022 and 2023
Opthea’s Phase III programme consists of two concurrent, global, randomized, sham- controlled studies enrolling approximately 990 patients across more than 20 countries in each trial. The primary end-point in both trials is mean change to visual acuity from base- line to week 52 for OPT-302 and anti-VEGF-A combination therapy compared with anti- VEGF-A monotherapy on its own. Following completion of the primary efficacy phase of the trials, Opthea intends to submit biologics license and marketing authorisation applications with the FDA and EMA respectively.
Look to biotechs conducting Phase III trials as peers
There are few Australian-listed biotechs which can be considered direct peers to Opthea. We look to biotechs such as Dimerix (ASX:DXB), Neuren Pharmaceuticals (ASX:NEU) and Telix Pharmaceuticals (ASX:TLX) as peers given they are all conducting Phase III trials. The US market yields more comparable peers both from the stage in their pipeline and disease targets. NASDAQ-listed peers include Kodiak (NASDAQ:KOD), which is also in late-stage trials for its Wet AMD and DME targets amongst other diseases; and Outlook Therapeutics (NASDAQ:OTLK), which is in Phase III trials on its therapies for Wet AMD.













Opthea Limited - Eyeing the Global Opportunity in Retinal Diseases

Australia

Opthea Limited is a biologics drug developer for ophthalmic diseases. The Company develops therapies for diabetic macular edema, corneal neovascularization and transplantation, and dry eye disease. Opthea serves patients and healthcare providers in Australia.

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Opthea Ltd (OPT AU)

Opthea Limited - Eyeing the Global Opportunity in Retinal Diseases

Opthea Limited Eyeing the global opportunity in retinal diseases Opthea Ltd (ASX:OPT) is a clinical-stage biotechnology company focused on...

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