US Ophthalmologists Report Increasing Trial of Roche/Genentech's Vabysmo in Diabetic Macular Edema, Though Regeneron's Eylea Maintains Its Strong Positioning, According to Spherix Global Insights

Coherus' new ranibizumab biosimilar, Cimerli, and the anticipated 8mg aflibercept formulation are predicted to further shake up the DME landscape in 2023

EXTON, Pa., Oct. 12, 2022 /PRNewswire/ -- Now on the market for over nine months, Roche/Genentech's Vabysmo (faricimab-svoa) has had success in expanding the breadth of users. However, depth of use is limited and has translated to minimal market share to date in diabetic macular edema (DME). The latest quarterly report included in Spherix's RealTime Dynamix™ service offered in DME captured feedback from 101 US ophthalmologists on their use and perceptions of both in-line and pipeline assets in this rapidly changing market.

Unsurprisingly, Eylea continues to dominate the space and has even shown a slight increase in brand share over the year, despite the added pressure from Vabysmo. Furthermore, off-label use of Genentech's Avastin and Lucentis in DME have remained relatively stable.

On the other hand, Novartis' latest launch for Beovu in DME is also off to a slow start. Indeed, safety signals identified early in the initial neovascular age-related macular degeneration (nAMD) launch have left lingering perceptions that have carried over to the DME market and relegated the brand as a last resort option.

As more biologic options become available, the use of intravitreal steroid implants continue to be pushed back further in the treatment algorithm. AbbVie/Allergan's Ozurdex and Alimera Science's Iluvien, already reserved for later-line patients, have continued to lose ground in the DME market. While ophthalmologists report more positive perceptions of Ozurdex than Iluvien when it comes to aspects such as safety concerns, access/cost issues, and overall manufacturer support, both implant brands are struggling in the current market.

Six-month brand share projections reveal Vabysmo is poised to gain some ground in the new year, likely bolstered by the recent receipt of the permanent J-code which should aid in ease of prescribing. Vabysmo's gains over the next six months do not appear to disproportionately impact any one asset but are in fact relatively dispersed across the DME biologic market.

However, Regeneron's strategy to remain top dog in the DME space appears to be panning out as planned with regard to the development of the 8mg formulation of aflibercept. Indeed, ophthalmologists are familiar with the developmental program and are eagerly anticipating availability of the new formulation. Though perceptions are positive, like many decisions made in the biologic world, price will continue to play an important role. Explicitly, respondents report that while the therapy has the potential to deliver up to an every-16-week dosing schedule, ophthalmologists still desire the ability to bill for reimbursement as low as every four weeks.

Despite these uncertainties, prescribers still anticipate they will likely switch a sizeable proportion of their current Eylea patients to the 8mg formulation if it is approved. Vabysmo may not lose existing patients to 8mg aflibercept, but it could potentially delay switching to Genentech's bispecific to a later line.

Another wild card in the mix is the recently launched ranibizumab biosimilar, Cimerli, by Coherus. Unlike its competitor in nAMD – Biogen and Samsung's Byooviz – Cimerli gained FDA approval for both the 3mg and 5mg dosing, allowing its use in DME (and an interchangeability designation granting it twelve months exclusivity post launch). Biosimilars are still very new to ophthalmology, and Byooviz manufacturers have done little to pave the way in terms of comfort or familiarity for the class (according to Spherix's RealTime Dynamix™ service offered in nAMD), leaving much of the heavy lifting to Coherus.

Regarding the DME pipeline, awareness is not particularly high overall. However, KSI-301 (Kodiak Science), RGX-314 (AbbVie/ RegenXbio), and OPT-302 (Opthea) have percolated to the top. RGX-314, a novel gene therapy comes in first place for most anticipated due to its potential to be "the closest thing to a cure" the space has ever seen.

RealTime Dynamix™ is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The Q3 2022 report published was released to subscribed clients in October.

Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Chrystal Ferguson, Ophthalmology Insights Director
 Email: [email protected]
 www.spherixglobalinsights.com

SOURCE Spherix Global Insights