Roche has unveiled new two-year data from late-stage studies of its ocular implant Susvimo in patients with diabetic eye conditions, as the Swiss pharma works to relaunch the product in a separate indication that it had previously withdrawn from the US market.
At the American Society of Retina Specialists’ annual meeting in Stockholm, the company said that Susvimo refilled every six months in the 634-subject Pagoda trial in diabetic macular edema maintained improvements in visual gains seen at one year for another year or so. Around 95% of Susvimo patients did not need additional injections.
Separately, in the 174-subject Pavilion trial, the implant refilled every nine months saw 80% of diabetic retinopathy (DR) patients experience a two-step or greater improvement on the Diabetic Retinopathy Severity Scale through the first 23 months of treatment.
Susvimo is a refillable eye implant that delivers a custom formulation of Roche’s anti-VEGF drug ranibizumab over time.
The drugmaker plans to relaunch Susvimo in the separate indication of wet age-related macular degeneration in the coming weeks after pulling it from the US market in 2022 due to problems with device components that the company said have since been addressed. In a bid to expand its label, Roche has also filed supplemental BLAs for Susvimo in DME and DR based on one-year data from the studies. The filing has been accepted by the FDA.
Christopher BrittainIn the DME trial, the control group was given once-monthly ranibizumab injections. “Going from monthly injections to having an implant and only having to go to the hospital potentially once every six months for a refill is just a massive benefit for these patients,” Christopher Brittain, global head of ophthalmology product development, told Endpoints News in an interview.
The product’s current label for wet AMD carries a black box warning for endophthalmitis, which is the inflammation of the inner coating of the eye. But there were zero cases of endophthalmitis in patients enrolled in both Pagoda and Pavilion during the first year.
In the DME trial’s two-year data, patients dosed with Susvimo had a 0.7% rate of endophthalmitis through 26 months versus 0.8% for the ranibizumab control group. In the DR study, Susvimo patients had a 0.8% rate of endophthalmitis through 23 months.
“When we implant the device, we spend a lot of time training the surgeons, because the majority of the adverse events occur in relation to the surgical procedure,” Brittain said. “We believe [the low rates of endophthalmitis] are really a marker of improving surgical techniques for these patients.”
If the candidate is approved in DME and DR, Brittain said that “it’s not a treatment that’s going to be given on the first day.” Physicians first need to establish that patients actually respond to anti-VEGF drugs, which will require around two or three rounds of intravitreal injections, and it can take up to a year to reach the “peak durability” of these injections, he added.
But in cases where a patient is already taking ranibizumab injections every 16 weeks, there could be an opportunity for them to have a “really great conversation” with their physician about Susvimo, Brittain said.
Editor’s note: This article was updated to add that Roche’s sBLAs have been accepted by the FDA and to clarify the timeframe of improvements in the Pagoda trial.