Samjin Pharmaceuticals said Monday that it has received Ministry of Food and Drug Safety (MFDS) approval for phase 2 clinical trials for SA001, a dry eye syndrome treatment.
SA001 received spotlight as it is the first dry eye syndrome drug to be taken orally.
The phase 2 clinical trial approval comes four years after the company 삼진제약 succeeded in developing new drug candidate in 2013 and two years after it started phase 1 clinical trials.
The safety and efficacy of the treatment will be tested in a randomized, multicenter, double-blind, and placebo-controlled clinical trials on 172 patients with dry eye syndrome at Seoul St. Mary’s Hospital 서울성모병원.
The drug has been designed to reach high levels of blood concentration in the eye after oral administration. Trials have confirmed that the increases goblet cells, which secrete mucin from the conjunctiva of the eye.
The accelerated mucin secretion is expected to help patients with dry eye syndrome, such as curing damaged sections of the eye, inducing anti-inflammatory actions and increasing tears.
The company is also developing an eye drop version, also known as SJP-002, of the SA001, which received approval from the MFDS 식품의약품안전처 for phase 1 clinical trial in June of last year.
“SA001 is expected to be effective even for intensive dry eye syndrome patients as it is designed to achieve high levels of blood concentration in the eye after oral administration,” said Shin Hee-jong 신희종, director of Samjin Pharmaceuticals’ Central Research Institute. “In the absence of an oral treatment for dry eye syndrome, SA001 will help improve the quality of life for many patients.”
<© Korea Biomedical Review, All rights reserved.>