A flourish of activity in the wet age-related macular degeneration (wAMD) market, coupled with anticipated approvals of other products—particularly biosimilars—is expected to widen interest in the AMD market among stakeholders, says GlobalData, a leading data and analytics company.

Vinie Varkey, Pharmaceutical Analyst at GlobalData, comments: “The wAMD market is on the precipice of a wave of new products. GlobalData’s Pharmaceutical Intelligence Centre (PIC) reveals that there are currently 15 products in late-stage development that are exclusively for wAMD in the 7MM*. The majority of these products fall either into the category of anti-vascular endothelial growth factor (VEGF) therapy, a drug class that is well-established for wAMD, or are biosimilars. In terms of innovation, RGX-314 from RegenxBio and AbbVie is a gene-therapy that has the potential to be used as a one-time treatment option for patients with wAMD.”

AMD is associated with the breakdown of the macular region of the retina that can cause significant vision loss. Among the different forms of AMD, only wAMD has approved treatment options. The standard of care for wAMD patients is anti-VEGF therapy, which can slow or inhibit the growth and leakage of blood vessels in the retina.

Product differentiation has been a key strategy employed by companies whose products have recently received approvals for wAMD. For example, Roche’s Susvimo (ranibizumab) received an FDA approval in October 2021. Patients who are 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. Vabysmo (faricimab), also from Roche, received FDA approval in January 2022 for wAMD and has potential to be administered less frequently than the current standard of care.

Varkey adds: “The frequency of administration associated with Susvimo and Vabysmo represent a significant alleviation of treatment burden when compared with the current standard of care, which are administered much more frequently. This feature makes these therapies an attractive option for patients and physicians in the field.”

While biosimilars are expected to directly target patient shares from their branded counterparts, Eylea (alibercept) and Lucentis (ranibizumab) are threatened by innovator molecules such as RGX-314 from RegenxBio and AbbVie. If approved, this therapy has the potential to disrupt current market dynamics for this sub-type of AMD.

Therapies are also in late-stage development for other sub-types of the disease, including dry AMD and geographic atrophy.

Varkey concludes: “Dry AMD and geographic atrophy are currently massively underserved, as there are no approved therapies.”

* 7MM: The US, France, Germany, Italy, Spain, the UK, and Japan.