Spherix Global Insights

September 01, 2022

Genentech’s Vabysmo Slowly Chips Away at Competition in the Neovascular (Wet) AMD Market While Regeneron’s Eylea Holds its Ground (For Now), According to New Spherix Report

Newer ranibizumab entrants, Byooviz (Samsung/Biogen) and Susvimo (Genentech), struggle to make an impact

EXTON, Pa., September 1, 2022 /PRNewswire/ – Since the FDA approval in January this year, ophthalmologists have been very optimistic about their intended use of Genentech’s Vabysmo (faricimab-svoa) for the treatment of neovascular (wet) age-related macular degeneration (nAMD). The latest quarterly report included in Spherix’s RealTime Dynamix™ service offered in nAMD captured feedback from 110 US ophthalmologists on the full inline and pipeline picture of the evolving treatment landscape.

To no surprise, Regeneron’s blockbuster anti-VEGF, Eylea, still reigns supreme in terms of brand share (among other metrics), with Genentech’s Avastin (bevacizumab, off-label) falling shortly behind. However, surveyed respondents report a gradual increase in use and share for Vabysmo quarter over quarter, while shares for its competitors have remained relatively flat or taken a slight dip.

While ophthalmologists initially anticipated most Vabysmo uptake to be at the expense of Eylea alone, it seems just as much of the new brand’s share is taken from Avastin and other treatment options. Though respondents anticipate Vabysmo share to double in the next six months with its increasing popularity, the brand has only captured a fraction of what was originally projected thus far in its launch.

So where is Vabysmo falling short? It’s not a lack of positive perceptions about efficacy, as nearly one-half of physicians believe it outperforms Eylea in that arena – and surely Vabysmo has the favorable dosing schedule with its longer duration option included in the label.

Surveyed ophthalmologists indicate that the absence of a permanent J-code (leading to reimbursement issues) is a key barrier to uptake for Genentech’s brand. Indeed, insurance/reimbursement concerns is the leading roadblock to biologic use in nAMD overall – implying that the availability of a J-code next month could allow highly favorable projections for Vabysmo to materialize.

Is it all downhill for Eylea once Vabysmo overcomes the reimbursement hurdle? An 8mg Eylea option (being investigated at both a 12-week and 16-week dosing schedule) is highly anticipated by ophthalmologists. Indeed, over two-thirds of respondents agreed that an on-label 16-week dosing option would be a real “game changer” in the market. However, while 8mg Eylea would serve as a worthy competitor against Vabysmo, ophthalmologists indicate it is more likely to reel in patients from Eylea 2mg.

Other newer market entrants – particularly Genentech’s Susvimo (ranibizumab) port delivery system (PDS) and Samsung Bioepis/Biogen’s Byooviz (ranibizumab biosimilar), have not experienced nearly the same success.

On the Byooviz and biosimilar landscape front, the brand has faced multiple challenges upon launch, which may be credited to the fact that the manufacturers are newer to the ophthalmology space and are still unfamiliar to prescribers – who are already split in their perceptions of comfort with prescribing biosimilars. Unfortunately, enthusiasm for the biosimilar does not appear it will pick up in the coming months, as less than one in five respondents anticipate an increase in use. Of note, Samsung and Biogen have a small window to act before Coherus Biosciences launches their ranibizumab biosimilar, Cimerli, in October and competition heats up.

As far as Susvimo, even with the benefit of being an alternative to frequent eye injections and considering the manufacturer’s calculated launch due to the required surgical procedure prior to use (implanting into the vitreous cavity and allowing for continuous release of the drug) – coming up on a year, the PDS is still not gaining traction. This could likely be attributed (in part) to the potential of less invasive agents like Vabysmo to provide a longer duration of action as well as anticipation of higher dosage options for tried-and-true brands like Eylea.

Ophthalmologists continue to have mixed opinions regarding the need for an on-label bevacizumab.  Overall, ophthalmologists generally agree an on-label bevacizumab could be a better option than repackaged off-label Avastin, if the price is right – and Outlook Therapeutics’ ONS-5010 (bevacizumab) could be the solution ophthalmologists are looking for. While commonly considered to be a biosimilar, the pipeline does not hold that title. A carefully executed launch will likely prevent Outlook from falling into the same trap as their biosimilar manufacturing counterparts.

Regarding the pipeline, Spherix data depicts there are high levels of excitement regarding gene therapy pipeline agents RGX-314 (AbbVie/RegenXBio) and ADVM-022 (Adverum), given their potential as a one-time treatment for retinal conditions. However, ophthalmologists are showing greater anticipation towards Kodiak Sciences’ KSI-301, given its familiar anti-VEGF MOA, promise of greater durability, and near-term potential.

 

About RealTime Dynamix™
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 August.

About Spherix Global Insights
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.

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