Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
Merck & Co. Inc. is shelling out $1.3 billion in cash up front to acquire privately held Eyebiotech Ltd., gaining rights to the latter’s pivotal trial-ready diabetic macular edema drug and a pipeline of earlier-stage candidates targeting vision loss. An additional $1.7 billion could follow in development, regulatory and commercial milestones, raising the deal total to $3 billion.
Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME.
Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME.
Théa Open Innovation, a subsidiary of France’s Laboratoires Théa SAS, returned rights to South Korea’s Curacle Co. Ltd.’s CU-06, an oral diabetic macular edema drug candidate. Curacle posted positive top-line phase IIa data of CU-06 just three months prior.
The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
Eluminex Biosciences Ltd. has presented results from preclinical studies of EB-105, a humanized trispecific antibody targeting IL-6 receptor (IL-6R), vascular endothelial growth factors (VEGFs) and angiopoietin-2 (Ang-2) for the treatment of diabetic macular edema.
Eluminex Biosciences Ltd. announced the FDA’s acceptance of their IND application for EB-105, a trispecific fusion antibody targeting vascular endothelial growth factor A (VEGF-A, and isomers), VEGF-B, placental growth factor (PlGF), angiopoietin-2 (Ang-2) and interleukin-6 receptor (IL-6R) for the treatment of diabetic macular edema (DME).
With Adverum Biotechnologies Inc.’s preliminary safety and efficacy data made public from the ongoing Luna phase II trial testing gene therapy ixoberogene soroparvovec (ixo-vec) in wet age-related macular degeneration (AMD), Wall Street promptly began stacking the results against those of competitors. CEO Laurent Fischer pointed out that ixo-vec boasts the “highest rate of injection-free patients of any study of any program at any dose.”
