Roche says FDA accepts vamikibart application, expects decision by July 2027
Key Facts
Roche said in a statement dated October 10 that the U.S. Food and Drug Administration had accepted its biologics license application for vamikibart, with patients in its clinical trials showing a reduced need for retreatment. The application seeks approval to treat uveitic macular edema in adults, a condition that can lead to permanent vision loss. Acceptance of the application marks a step in the regulatory review process, rather than approval to market the drug in the United States. The company said about two-thirds of eligible patients "did not require retreatment after week 16". It added that most patients who required retreatment needed only one additional injection during follow-up.
The Phase 3 MEERKAT trial enrolled 245 participants, according to Roche's announcement of its primary analysis results. SANDCAT, which also tested the drug, enrolled 256 participants. The primary endpoint measured the proportion of participants whose best-corrected visual acuity improved by at least 15 letters from baseline at week 16, according to Genentech. MEERKAT demonstrated statistically significant superiority over a sham procedure on this endpoint, Roche said. SANDCAT did not achieve the same statistical superiority, leaving the trials with different primary endpoint results despite using the same measure of visual improvement.
Roche cited differences in patients' baseline characteristics and concomitant medications as potential factors behind the divergent results, without establishing them as the cause. Follow-up from both trials showed sustained improvements in vision and reductions in macular thickness through week 52, according to the company's latest statement. In the response analysis, patients who received rescue treatment or prohibited therapy were treated as non-responders, according to the company's official presentation. On safety, conjunctival hemorrhage and increased intraocular pressure were among the most common adverse events in vamikibart recipients in the primary analysis. Roche also said no cases of occlusive retinal vasculitis were reported in that analysis.
Macular edema develops when fluid leaks from blood vessels into the macula, a part of the retina, according to the U.S. National Eye Institute. The fluid buildup causes the macula to swell and vision to blur, making improved vision and reduced swelling relevant aspects of treatment. Uveitis can affect anyone but is more common between the ages of 20 and 60, according to the institute. Roche says about 20% of patients with uveitic macular edema progress to permanent blindness within 3 years of diagnosis. The company also notes that the edema can persist or recur despite current treatments.
The earlier MERIT treatment trial enrolled 194 people with controlled uveitis but persistent or recurrent macular edema, according to the U.S. National Eye Institute. Corticosteroid treatment reduced retinal swelling more than ranibizumab and methotrexate in that comparison, according to the institute. The corticosteroid was also the only treatment that improved vision in the study, highlighting its role in treating these complications. However, Roche cited the risk of cataracts among the safety limitations of corticosteroid treatment in its investor presentation. Those limitations also include increased intraocular pressure or glaucoma, alongside the cataract risk associated with these treatments.
Vamikibart targets interleukin-6, a mediator in the inflammatory pathway associated with the disease, according to Genentech. The company says the drug could, if approved, become the "first targeted non-steroidal treatment" for uveitic macular edema. The drug has orphan drug designation in the United States and the European Union, according to the company. Alongside the U.S. process, regulatory applications have also been submitted and accepted in the European Union, China and Japan, according to Genentech's statement. Roche expects an FDA approval decision by July 2027, the drug's next announced regulatory milestone in the United States.