Daewoong Pharmaceutical's Nabota, its botulinum toxin (BTX) strain, has obtained additional approval from the Ministry of Food and Drug Safety to treat eyelid spasms.
|Daewoong Pharmaceutical's botulinum toxin Nabota|
The ministry granted approval based on the results of phase 3 clinical trial conducted on 230 adults diagnosed with basal eyelid spasms. The double-blinded study evaluated the efficacy and safety of the treatment by injecting either Nabota or Botox every four weeks for a total of 12 weeks.
Using the Scott classification, which divides the degree of facial spasm to five levels, the company investigated the percentage of patients who had their eyelid spasm improve.
As a result, 96.15 percent of Nabota group and 96.12 percent of Botox group showed improvement after four weeks of administration.
"The result proved the non-inferiority of Nabota when compared with Botox," the company said.
Also, there were no significant differences between the groups regarding evaluations of the eyelid spasms disease-specific functional measures and the patients.
"With the approval of using Nabota as a treatment for eyelid spasms, the company has further strengthened its presence in the therapeutic market as well as in the beauty market," said Park Sung-soo, head of Daewoong's Nabota business division. "The global BTX market has larger growth potential for the treatment market than the aesthetic market."
The company expects Nabota's market competitiveness as a global brand to be further strengthened by the addition of this indication for treatment, Park added.
With the approval, Nabota now has four approved indications -- wrinkles, upper limb muscle stiffness, eye wrinkles, and eyelid spasms.
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