Product approvals and unmet treatment needs expected to widen interest in AMD – Pharmaceutical Technology

Wet age-related macular degeneration (wAMD) has recently witnessed a series of approvals thanks to a degree of product differentiation, and this has drawn enthusiasm from multiple stakeholders in the field. This interest is expected to be widened with the anticipated approvals of more products, particularly biosimilars. Despite this, a lack of treatment options for other sub-types of the disease means that opportunities are still available for pharmaceutical companies to make a difference to patients affected by AMD.

Product differentiation has been a key strategy employed by companies whose products have recently received approvals for wAMD. Consider for example Roches Susvimo (ranibizumab), which received US Food and Drug Administration (FDA) approval in October last year. Patients implanted with Susvimo are expected to visit their doctor only twice yearly to have the implant refilled so that the medicine can be delivered to their eyes continuously. That represents a significant alleviation of treatment burden when compared with the current standards of care such as Lucentis (ranibizumab), Eylea (aflibercept) and Beovu (brolucizumab), which need to be administered more frequently.

Vabysmo (faricimab), also from Roche, received FDA approval in January this year for wAMD and for diabetic macular oedema. This therapy is administered every four weeks for the first four doses, following which, depending on the results of optical coherence tomography and visual acuity evaluations, there is potential for the frequency of administration to be reduced to as few as twice a year, resulting in a lower cost of treatment compared to standard of care. While it remains to be seen to what extent these new therapies will be commercially successful, being associated with lesser frequency of administration already makes such therapies an attractive option for patients and physicians in this field.

Looking ahead, anticipated launches of new biosimilars and innovator molecules are expected to widen interest in the field of AMD. According to GlobalDatas Pharmaceutical Intelligence Centre (PIC), there are currently 15 products in late-stage development exclusively for wAMD in the seven major markets (7MM: the US, France, Germany, Italy, Spain, UK and Japan). Five of these are aflibercept biosimilars and four are ranibizumab biosimilars. While both groups of biosimilars are expected to directly target patient shares from their branded counterparts, Eylea (aflibercept) and Lucentis (ranibizumab), the latter two also face threats from innovator molecules including RGX-314 from RegenxBio and AbbVie. This is a gene therapy that has the potential to be used as a one-time treatment option for patients with wAMD and, if approved, has the potential to disrupt current market dynamics for this sub-type of AMD.

In addition, there are gaps that exist in the market, particularly for therapies that can help patients with dry AMD and geographic atrophy, for which there are currently no approved therapies available. According to GlobalDatas PIC, there are three therapies in late-stage development for geographic atrophy: Alkeus Pharmaceuticals ALK-001, Apellis Pharmaceuticals pegcetacoplan, and IVERIC bios avacincaptad pegol sodium. Dobecure SLs therapy ethamsylate is also in development for both dry AMD (dAMD) and wAMD. It remains to be seen, however, how effective these therapies will be in addressing the disease at an earlier stage, as it is crucial to treat these diseases before they progress further.

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Product approvals and unmet treatment needs expected to widen interest in AMD - Pharmaceutical Technology