Roche reports vamikibart vision gains through week 52 in two trials
The FDA accepted the uveitic macular edema application after MEERKAT met its primary endpoint and SANDCAT did not.
Adrian Kessler
An FDA decision on vamikibart is expected by July 2027 after Roche Holding AG SWXROP OTCMKTSRHHBY reported sustained vision and retinal thickness improvements through week 52 in two uveitic macular edema trials on Oct. 10. Its update says about two thirds of eligible patients needed no further injections after week 16, but it does not quantify the week 52 gains by treatment arm.
The U.S. Food and Drug Administration has accepted Roche's biologics application for the investigational eye injection, the company said. The filing draws on the MEERKAT and SANDCAT Phase III studies, whose earlier primary analyses differed: MEERKAT achieved statistical significance against sham injections at week 16, while SANDCAT did not.
Roche is a large Swiss pharmaceuticals and diagnostics group.
Roche's U.S. traded shares closed at US$54.09 on Friday, Oct. 9, up 1.35 per cent at 4 p.m. EDT, according to OTCMKTSRHHBY on Google Finance. That close preceded the Oct. 10 data announcement and cannot show a trading reaction to it.
Read more: Roche Holding AG gains FDA approval for Tecentriq in stage III dMMR colon cancer
SANDCAT's Primary Endpoint Was Not Met
Roche's Oct. 17, 2025, primary analysis listed 245 participants in MEERKAT and 256 in SANDCAT. In both studies, patients were assigned to a sham procedure or injections of 0.25 milligrams or 1 milligram of vamikibart every four weeks through week 16, with treatment as needed afterward. The primary endpoint was the share gaining at least 15 letters in best corrected visual acuity by week 16.
In MEERKAT, the 1 milligram group's lead over sham on that endpoint was 36.9 percentage points, with a P value below 0.0001. The 0.25 milligram group's lead was 19.9 points, with a P value of 0.0008. These comparisons come from the 2025 analysis, rather than the new one year presentation.
SANDCAT showed a 10.9 point lead for the 1 milligram group against sham, with a P value of 0.0699, in that same 2025 analysis. Roche called the 0.25 milligram group's 20.7 point lead nominally significant, but said the study did not achieve statistically significant superiority on the primary endpoint. The distinction leaves the FDA to assess the two trials together with the longer follow up.
Read more: Bristol Myers Squibb reports 51 per cent lower progression or death risk with Zenbexus regimen
At week 52, Roche said a numerically larger proportion of treated patients gained vision than sham recipients in both studies. It also reported sustained improvements in average vision and central retinal thickness, but supplied no percentages, confidence intervals or P values for those comparisons in its Oct. 10 release. That limits how precisely the added durability can be measured from the public summary.
Roche described a low incidence of treatment related eye adverse events and inflammation at week 52, without providing counts. Its 2025 analysis identified conjunctival hemorrhage and raised eye pressure among the more common adverse events and reported no retinal occlusive vasculitis at that earlier point.
"These one-year results strengthen vamikibart's clinical profile, confirming that initial visual and anatomical improvements are maintained over 52 weeks," Roche chief medical officer Levi Garraway said in the Oct. 10 release.
FDA Review Covers Both Trials
Vamikibart targets interleukin-6, a pathway involved in ocular inflammation. Roche describes steroids as the main treatment for uveitic macular edema and says their longer use can raise eye pressure or cause cataracts. Neither trial compared vamikibart directly with a steroid, so the sham controlled results cannot establish superiority over an existing treatment.
The broader biotechnology market offers context before investors can see a reaction to Roche's weekend announcement. The iShares Biotechnology ETF NASDAQIBB traded at US$202.70 at 9:33 a.m. EDT on Oct. 9. That sector snapshot also predates the presentation.
Roche has disclosed the FDA's acceptance of its application, but the Oct. 10 release gives no agency assessment of the sham comparator or the different primary outcomes. It also gives no drug specific spending or cash runway estimate. The FDA decision expected by July 2027 will decide whether to approve vamikibart for uveitic macular edema in the United States.
