Image from Unsplash user Amanda Dalbjörn
New macular degeneration treatments could offer superior durability to current anti-vascular endothelial growth factor therapy (anti-VEGF). But new drugs must have a similar safety profile to existing therapies to be competitive, according to a UBS briefing note.
The macular degeneration treatment landscape changed significantly in 2005 when FDA approved Macugen (pegaptanib sodium injection) from Pfizer (NYSE:PFE) to treat age-related macular degeneration.
Lucentis (ranibizumab) from Genentech, now a Roche (OTCMKTS: RHHBY) subsidiary, won FDA approval a year later. Eylea (aflibercept) from Regeneron Pharmaceuticals (NSDQ:REGN) became a third-generation treatment for the condition when the FDA approved it in 2019.
Promising new drugs for the condition include ADVM-022 from Adverum Biotechnologies (NSDQ: ADVM), KSI-301 from Kodiak Sciences (NSDQ: KOD) and RGX-314 from Regenxbio (NASDAQ: RGNX).
In a recent call hosted by UBS analyst Esther Rajavelu, two vitreoretinal clinician-scientists hinted that they would be unwilling to risk adverse events for a longer duration of effect.
“It is a high bar to demonstrate superior efficacy to establish standards of care, however evidence largely supports durability benefits, the most important unmet need,” Rajavelu wrote.
Current anti-VEGF drugs, which are administered via injections to the eye, require periodic treatment, which can burden patients and the healthcare system.
Current anti-VEGF drugs are typically injected once every four to six weeks in the early stages of treatment. KSI-301 from Kodiak Sciences, conversely, might be injected once every four to six months based on data from Phase 1b clinical trial.
If next-gen anti-VEGF agents are accompanied by higher inflammation than current therapies, they could fail to gain favor. Conversely, if new treatments could reduce the burden of treatment or offer enhanced efficacy, they could find a place in a market that will be worth $18.7 billion in 2028, according to GlobalData estimates.
Another wrinkle though is that biosimilars for macular degeneration could hit the market before novel treatments receive regulatory approval.
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