ReBio Pharma Completes Pre-IND Meeting: Clearing Path direct to Phase II for RBLP sustained release treatment for glaucoma
Turku, Finland, 22 June 2021 - Rebio Pharma (“ReBio” or the “Company”), a pre-clinical stage biotechnology company with an injectable bioresorbable sustained release delivery platform, SiSu®, for ophthalmic therapeutics, today announced that is has completed a Type B pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding ReBio’s proposed development program for RBLP in the treatment of mild to moderate primary open-angle glaucoma.
ReBio has gained alignment with FDA on its proposal to initiate clinical development of RBLP, a 6-month sustained release formulation of latanoprost, in a Phase II dose-ranging study comparing RBLP to the standard of care (latanoprost topical drops) in latanoprost-tolerant patients. The Agency agreed with the Company’s proposal for a single IND-enabling non-clinical study and progressive plans for chemistry, manufacturing, and control (CMC) development. The Company’s target initiation of the first clinical study for RBLP in Q4’2023 remains on track.
In the video-conference meeting with the FDA’s Division of Ophthalmology, ReBio also received guidance on primary endpoint approaches for Phase III, and obtained the Agency’s agreement to review the Company’s initial clinical trial protocol prior to IND submission.
“We are very pleased with overwhelmingly positive feedback received from the Agency for this program, which also provides valuable insight into the regulatory treatment of the SiSu® platform more generally,” said Vinod Vijayakumar, Chief Executive Officer. “We appreciate the FDA’s guidance and collaborative approach to the development of ReBio’s platform for the treatment of chronic eye diseases.”
RBLP is ReBio’s lead program, intended for use as a sustained release intravitreal injection administered twice per year. The Company’s SiSu® platform has been designed to be adaptable to both target and compound, enabling the development of sustained release treatments to chronic diseases of both the front and back of the eye.