The diabetic macular oedema (DME) market is anticipated to reach values of $11.1bn in 2031 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan). This follows the US Food and Drug Administration’s (FDA) recent approval, in January this year, of Roche’s Vabysmo (faricimab) for DME, coupled with the anticipated approval of pipeline therapies in the forecast period from 2021 to 2031, which are expected to drive the growth of the DME market in the 7MM.

A critical factor that has been targeted in more recent years by companies within the DME space to heighten their chances of success on entering the DME market is the frequency of administration associated with a therapy. A recent example of this is the newly approved Vabysmo, an anti-vascular endothelial growth factor (VEGF) therapy that has a comparatively lower frequency of administration than those of the standard-of-care treatments Eylea (aflibercept), Lucentis (ranibizumab) and Avastin (bevacizumab). The latter of these is used off-label for DME patients and is of interest, as Outlook Therapeutics is currently working on developing Lytenava, a branded version for this indication. Key opinion leaders (KOLs) have expressed that Vabysmo requires six treatment days a year on average, with data showing that the frequency may be reduced to as little as twice a year following the loading phase—which comprises four injections, one administered every four weeks—depending on visual acuity (VA) and optical coherence tomography (OCT) results.

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Looking ahead, many of the current late-stage pipeline products for DME mostly mirror what is currently on the market, employing anti-VEGF mechanisms of action. This includes Kodiak Sciences’ KSI-301 and Roche’s Susvimo (ranibizumab sustained release formulation), the latter of which is already approved for wet age-related macular degeneration (AMD) and has a significantly reduced frequency of administration of two days a year. Two therapies that are anticipated to reach the DME market during the forecast period will introduce new mechanisms of action in the space: APX-3330, which specifically targets apurinic/apyrimidinic endonuclease 1/redox effector factor-1 (APE1/Ref-1) protein, and THR-149, a plasma kallikrein inhibitor.

This is of great benefit within the DME space, especially in the case of patients who have not experienced any benefit from currently marketed therapies and need alternatives. Furthermore, the market is currently saturated with therapies that employ an intravitreal route of administration, but two therapies are currently in the pipeline that employ alternative routes of administration: APX-3330 and dexamethasone acetate, the former of which employs an oral route of administration, and the latter of which is topical eye drops. As these therapies can be self-administered, this will greatly reduce treatment days, which is of paramount interest as most patients with DME are of working age.

While the DME market is projected to grow strongly in the forecast period, potential barriers to this growth include loss of exclusivity within the forecast period. For example, Eylea (aflibercept) is set to lose market exclusivity in the US next year and in the 5EU (France, Germany, Italy, Spain and the UK) this year, leading to the anticipated entry of biosimilars. Ranibizumab biosimilars are also set to enter the DME market during the forecast period, which will undoubtedly compete with their parent drug, Lucentis. However, the launch of Vabysmo and other late-stage pipeline therapies with lower frequencies of administration, new mechanisms of action and new routes of administration are undoubtedly a driving force for market growth in the DME space.

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