Daewoong Pharmaceutical said it has expanded the indication of Nabota, the locally-developed botulinum toxin.
The drug company said it won an additional approval from the Ministry of Food and Drug Safety for Nabota Inj. 50 Unit’s indication of the wrinkles for the outer corner of the eyes on Tuesday.
Nabota is the first botulinum toxin in Korea to obtain the nod for smoothening crow’s feet, Daewoong said.
Nabota has had two indications -- for wrinkles between the eyebrows and rigid upper muscles caused by a stroke. With the additional indication, the cosmetic treatment has three indications including wrinkles around the outer corner of the eyes.
The approval for the additional indication was based on a phase-3 trial in 204 adults with moderate to severe eye wrinkles. In the study, researchers administered Nabota 12 Unit to lines around the one eye, and Botox 12 Unit to those of the other eye. Then, researchers evaluated efficacy and safety every four weeks, for a total of 16 weeks.
After four weeks, patients treated with Nabota showed 65 percent improvement in wrinkles and those with Botox, 62.6 percent. This means that Nabota proved its non-inferiority to Botox, Daewoong said. Also, Nabota was non-inferior to the original Botox in patients’ evaluation of wrinkle improvement rate, satisfaction in wrinkle improvement, and appearance satisfaction, it said.
Besides, the company conducted an extended test that simultaneously administered Nabota to the crow’s feet and wrinkles between the eyes, to check the efficacy and safety.
At the fourth week, participants of the study graded 81.3 out of 100 in appearance satisfaction, much higher than the score in injections into the wrinkles around the corner of the eyes only. Regarding safety, there was no significant difference between injecting it to both and doing so only to the creases between the eyes, the company said.
“To win the indication for crow’s feet for the first time in Korea, we newly developed evaluation methods for domestic patients because the existing evaluations were centered on the western world. We could finally obtain approval after collaborations with researchers and data analysis,” said Jeon Seung-ho, CEO of Daewoong Pharmaceutical.
The drugmaker said it was conducting clinical trials to further expand Nabota’s indications for the treatment of involuntary tight closure of the eyelids and square jawlines (benign masseteric hypertrophy).