March 12, 2020 / 7:05 AM / in 18 days

BRIEF-Redwood Pharma: RP101 Demonstrates Efficacy And Safety In Phase II Study

March 12 (Reuters) - Redwood Pharma AB:

* RP101 DEMONSTRATES EFFICACY AND SAFETY IN PHASE II STUDY OF PATIENTS WITH MODERATE-TO-SEVERE DRY EYE DISEASE

* ALL OBJECTIVE AND SUBJECTIVE PARAMETERS SHOW IMPROVEMENT

* FAST ONSET: STATISTICALLY SIGNIFICANT EFFICACY AFTER JUST 14 DAYS

* SIGNIFICANT IMPROVEMENT OF OBJECTIVE AND SUBJECTIVE ENDPOINTS IN PHASE II STUDY IN POSTMENOPAUSAL WOMEN WITH MODERATE-TO-SEVERE DRY EYE

* RP101 MORE THAN DOUBLES TEAR FLUID PRODUCTION

* OBJECTIVE SCHIRMER TEST REACHED 9.6 MM COMPARED TO NOMINAL 10 MM GOAL FOR PRIMARY ENDPOINT

* PRIMARY ENDPOINT OF SCHIRMER TEST OF 10 MM WAS AN ASPIRATIONAL GOAL WHEN SETTING UP TRIAL WITH EXPECTATIONS OF DOUBLING TEAR PRODUCTION FROM BASELINE.

* MEDIAN BASELINES OF TREATMENT GROUPS WERE LOWER AND MORE CHALLENGING THAN EXPECTED, BEING AROUND 4 MM

* FACT THAT RP101 MANAGED TO MORE THAN DOUBLE PRODUCTION AND REACH 9.6 MM IS STATISTICALLY SIGNIFICANT.

* IN BRIEF, RP101 IS CONSIDERED SAFE

* AFTER 3 MONTHS, ALL ACTIVE GROUPS SHOW IMPROVEMENT FOR ALL SYMPTOMS Source text for Eikon: Further company coverage: (Gdansk Newsroom)

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