Opthea Limited - Eyeing the Global Opportunity in Retinal Diseases

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.