A Biosimilar for Wet Age-related Macular Degeneration
Chong Kun Dang announced on Nov. 23 that the results of a phase 3 clinical trial of LucenBS, a biosimilar referencing Lucentis to treat wet age-related macular degeneration (AMD) have been published in PLOS One, an SCI-level international academic journal.
LucenBS is a high-purity Lucentis biosimilar with ranibizumab as the main ingredient. It is mass-produced through Chong Kun Dang’s proprietary antibody fragment raw material manufacturing technology and used to treat macular degeneration and diabetic macular edema. The company obtained approval for the biosimilar from the Korean Ministry of Food and Drug Safety on Oct.r 20 and plans to launch it in January 2023.
Chong Kun Dang conducted the phase 3 clinical trial of LucenBS on a total of 312 patients with neovascular age-related macular degeneration (nAMD) at 25 hospitals, including Seoul National University Hospital, from September 2018 to March 2021.
According to the clinical trial, in the primary efficacy evaluation that compared best corrected visual acuity (BCVA) at 3 months after drug administration, the proportion of patients who showed vision loss of less than 15 letters was 97.95 percent (143 of 146 persons) in the LucenBS administration group, and 98.62 percent (143 of 145 persons) in the original drug administration group, indicating that the two drugs met the range of equivalence.
Changes in best corrected visual acuity (BCVA) were an improvement of 7.14 letters in the LucenBS administration group and an improvement of 6.28 letters in the original drug administration group, showing no significant difference between the two drugs. Three, six and 12 months after the drug administration, LucenBS was confirmed to be clinically equivalent to the original drug in terms of drug efficacy, safety, immunogenicity, and pharmacokinetic characteristics, through indicators such as the percentage of patients with vision loss of less than 15 letters and an improvement in visual acuity and changes in central retinal thickness among others.