Biospector Reporter Seo Yoon-seok
Published in ‘PLOS One’, an international academic journal…’LusenVS’ by Chong Kun Dang confirmed the equivalence of the original drug and the best corrected visual acuity (BCVA)
Chong Kun Dang announced on the 23rd that the results of the phase 3 clinical trial of Lucentis biosimilar Lucentis, a treatment for macular degeneration, have been published in the international journal PLoS One.
Lucenbis is a high-purity Lucentis biosimilar with ranibizumab as the main ingredient. It is mass-produced with Chong Kun Dang’s proprietary antibody fragment raw material manufacturing technology and is used for macular degeneration and diabetic macular edema. Lusenbies received approval from the Ministry of Food and Drug Safety last month and is expected to be released in January next year.
Between September 2018 and March 2021, Chong Kun Dang conducted phase 3 clinical trials of LussenBS for a total of 312 patients with Neovascular Age-Related Macular Degeneration (nAMD) at 25 hospitals, including Seoul National University Hospital .
Chong Kun Dang analyzed the proportion of patients with vision loss of less than 15 letters at 3 months post drug administration as the primary end point. As a result, the best corrected visual acuity (BCVA) was found to be 97.95% (143/146 patients) in the LusenBS-treated group and 98.62% (143/145 patients) in the original group that received drug treatment, meeting the equivalence range between the two drugs.
The change in best-corrected visual acuity (BCVA) improved by 7.14 letters in the LusenBS-treated group and by 6.28 letters in the original drug-treated group, showing no significant difference between the two drugs. After 3, 6, and 12 months of drug administration, the percentage of patients who showed visual loss and visual improvement of less than 15 letters, respectively, and changes in central retinal thickness were analyzed. All pharmacokinetic properties were confirmed to be clinical equivalent to the original drug.
Macular degeneration is a disease in which the macula, tissue that receives light from the retina, loses its function due to aging and inflammation or, in severe cases, leads to blindness The number of patients is continuously increasing in after the global aging phenomenon. . Wet macular degeneration, where exudate or blood leaking from abnormally formed blood vessels, causing structural changes and damage to the retina and macula, is known as one of the three leading causes of blindness in the elderly over 65 age
Dr said. Hyung-Gon Yoo, author of the clinical paper on Lusenbis, “Lusenbis is a drug that has shown clinical equivalence to Lucentis, the original drug, in key indicators, including the primary endpoint, best-corrected visual acuity.” It is expected to not only stabilize the condition of macular degeneration, but also reduce the patient’s treatment burden due to the administration of stable drugs.”
