Checking the statistically significant difference by turning off the secondary variable
Three phase 3 analyzes to find out the possibility of a’Pre-BLA meeting’
Gtree B&T(14,600 -29.47%)Announced the major results (top line) of the third phase 3 clinical trial in the US (ARISE-3) of’RGN-259′, a treatment for dry eye syndrome on the 18th.
ARISE-3 is a clinical trial conducted in US ophthalmology hospitals with 700 subjects. There was no statistically significant difference in eye discomfort and corneal staining scores in the inferior region, which were selected as the primary endpoint. The safety of RGN-259 and some secondary endpoints confirmed the therapeutic effect.
In the case of symptoms (Symptom), the second evaluation item, Ocular grittiness, showed a statistically significant difference at the time point after 1 week of treatment, 2 weeks after treatment, and after exposure to severe conditions after 2 weeks of administration. In addition, as in previous clinical trials, it showed superior safety compared to other dry eye treatments.
A GTRIBNT official said, “This is the result of repeatedly confirming the safety and the effectiveness of the two-week treatment for dry eye syndrome of RGN-259, which was shown in previous clinical trials.”
GTRIBNT is analyzing the signs and possible effects of symptoms through the results of all three phase 3 clinical trials performed so far through a US statistical company. In symptom evaluation variables, it was confirmed that the staining scores of the central corneal area, the total corneal area, the conjunctival area, and the entire ocular area showed a statistically significant difference after 2 weeks of administration.
In the future, the company expects to obtain additional results through full and post-analysis including additional evaluation variables. Final results of ARISE-3 clinical trials, including further analysis, will be disclosed upon completion of the analysis.
An official of the company said, “Additional analysis will focus on the confirmation of the effect on all evaluation variables and the rapid expression of RGN-259 and the multifunctional therapeutic effect confirmed in existing clinical trials.” Through consultation, the U.S. Food and Drug Administration (FDA) after evaluating the possibility of promoting the pre-market approval (Pre-BLA meeting), or establishing a strategy for the necessity of the next clinical trial and the direction of detailed plans for the next clinical trial. We will discuss it immediately,” he explained.
Reporter Minsoo Han [email protected]
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