RIBOMIC Inc. announced that the Eye has published full results from the phase 1 (SUSHI) and phase 2 (TOFU/RAMEN/TEMPURA) trials evaluating the efficacy and safety of intravitreal umedaptanib pegol in nAMD1,2. TOFU is a randomized, double-masked study assessing the efficacy of intravitreal uMedaptanib pegol monotherapy or in combination with Eylea®?, compared to Eylea®? monotherapy in 86 subjects with anti-VEGF pretreated nAMD. RAMEN is an extension study of TOFU, in which 22 subjects who had exited the TOFU study received 4 monthly intravitreal injections of umedapt anib pegol.

TEMPURA is an investigator-sponsored, single-center, open-label, 4-month study of umedaptanib Pegol in five treatment-naive nAMD patients. Throughout these studies umedaptanib pegOL was safe, well tolerated, and effective to treat nAMD patients with no or short history of anti-VEGF treatment. Striking improvements in visual acuity and anatomy were observed in some of the treatment naive patients.

In nAMD patients with a long history of anti-VEGF therapy, umedaptanib pegal showed no additional benefit of monotherapy or the combination over Eylea®?. Nevertheless, the pre-existing fibrosis remained stable without worsening in these studies. Notably, visual acuity decreased slightly in patients who switched from anti-VEGF (Eylea®?) to umedaptanib pegola in the RAMEN study.

The leakage of fluid from the vessels causes retinal thickening and retinal degeneration including fibrotic scar formation, and leads to severe and rapid loss of vision.