Enforcement Report - Week of December 27, 2023
TEL AVIV, Israel & MELBOURNE, Australia--(BUSINESS WIRE)--Azura Ophthalmics Ltd., a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its Phase 2 clinical study protocol of AZR-MD-001 in Meibomian Gland Dysfunction (MGD). AZR-MD-001 is currently being studied in an ongoing multi-center Phase 2b clinical trial and topline data is expected in the fourth quarter of 2022.
TEL AVIV, Israel & MELBOURNE, Australia--(BUSINESS WIRE)--Azura Ophthalmics Ltd. (Azura), a clinical-stage biopharmaceutical company developing a new therapeutic class of Ophthalmic Keratolytics for ocular surface diseases, today announced that the company was awarded a grant from CUREator, Australia’s national biomedical incubator managed by Brandon BioCatalyst. The grant will support Azura’s two-stage study evaluating the safety, tolerability and efficacy of the company’s lead clinical candidate, AZR-MD-001, in patients with contact lens discomfort (CLD) who show evidence of Meibomian gland dysfunction (MGD).