After months of back-and-and forth with the FDA and a third-party manufacturer, Regeneron has secured two long-awaited approvals for Eylea HD, gaining a new indication and a more flexible dosing option for the eye disease drug.
The FDA has signed off on Eylea HD for patients with macular edema following retinal vein occlusion (RVO), making it the first treatment available in the indication with dosing up to every eight weeks. The agency also endorsed a monthly dosing option for Eylea HD across each of its approved indications, which include wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR) and now RVO.
The nods allow Regeneron to better compete with Roche, which stormed the market in 2022 with Vabysmo. The Swiss drugmaker's long-acting treatment can be administered up to every four months, as opposed to Regeneron’s original 2 mg version of Eylea, which has a maximum dosing interval of every two months.
Regeneron and partner Bayer's Eylea HD can also be dosed up to every four months in wAMD and DME, but the companies have still been playing catch-up with Roche's formidable eye disease med.
Now, Eylea HD is “no longer fighting Vabysmo with both hands tied behind its back,” Evercore ISI analyst Cory Kasimov wrote in a Thursday investor note, adding that the new approvals “should enable a true inflection in market adoption.”
A key potential approval still awaits for Eylea HD's prefilled syringe (PFS), Kasimov added. Again, Regeneron and Bayer are playing catch-up as Roche earned its PFS go-ahead from the FDA in July of 2024.
Last month, the FDA rejected Regeneron’s bid for a PFS approval, citing unresolved issues at the Indiana plant of its manufacturing partner, Novo Nordisk. Regeneron said that it continues to work with Novo to resolve problems at the former Catalent plant that were identified in a July inspection. The company plans to resubmit an application, which will include an alternate PFS manufacturer, in January.
As for the monthly dosing option for Eylea HD, Regeneron said that the new nod is key because some patients in trials did not maintain a response with extended dosing intervals after successful responses to initial monthly doses. After an initial monthly dosing regimen, Eylea HD was previously approved for dosing every 8 to 16 weeks for patients with wAMD and DME and every 8 to 12 weeks for those with DR.
“Prior to this approval, docs would be on the hook for the drug cost if Eylea HD required more frequent dosing than on the label,” Kasimov wrote. “The inclusion of (four-week) dosing will now allow for payers to reimburse here. Based off our KOL feedback, the lack of (four-week) dosing on the label had been a source of headache for retina docs. This update is a win on this front.”
Meanwhile, Eylea HD’s RVO label does not have Vabysmo’s six-month dosing limitation, Kasimov pointed out, allowing the Regeneron medicine to “now have a rare advantage” over Roche’s drug.
“Eylea HD is the first treatment for retinal vein occlusion that can potentially cut the number of injections that patients receive in half compared to existing therapies," George Yancopoulos, M.D., Ph.D., Regeneron’s co-founder and chief scientific officer, said in a release. "And with the addition of a monthly dosing option for all four approved Eylea HD indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”
In August, the FDA extended its target action dates for the RVO and flexible dosing applications because of the manufacturing issues at the Indiana plant.
Three weeks ago, Regeneron reported that sales of Eylea HD reached an all-time high of $392 in the third quarter. The bad news, however, was that while sales from Eylea HD increased by 29% sequentially, it didn’t translate to a similar bump in overall U.S. revenue for the Eylea family of eye medications. From Q2 to Q3, franchise sales increased only marginally—from $1.535 billion to $1.537 billion.
Meanwhile, Roche reported that worldwide third-quarter sales of Vabysmo were up 8% sequentially, from 947 million CHF ($1.09 billion) in the second quarter to 1,022 million CHF ($1.18 billion) in the third quarter.
The companies are also battling new competition from biosimilars as Eylea has lost its patent protection. In the third quarter, Amgen posted sales of its Eylea biosimilar Pavblu at $213 million.