Petition updateUrge Azura Opthalmics to Offer AZR-MD-001 Through FDA Expanded Access

We have sent out voices to Azura Opthalmics and received their response.

D RobertsUnited States
Dec 15, 2024

Hello everyone and thank you for your support. We've sent our petition to Azura Opthalmics and gotten their reply to this request. Unfortunately, the news is not what we were all hoping for. I will include the reply by Doctor Charles Bosworth here for you all: 

"Thank you for reaching out. Your experience with MGD is why we are working so hard to develop new medicines, given the needs of patients like yourself. 

At this time, Azura is not offering programs that allow access to our investigational medicines prior to regulatory approval anywhere in the world. As a private biotech company, we are using our resources to work diligently to follow a rigorous and compliant clinical trial and regulatory process, conducted in partnership with researchers, physicians, patients, and global regulators, to ensure broad access to potential new treatments to patients who need them around the world. We are unable to dedicate our limited resources to an Early Access program for individual patients. 

We are working as quickly as possible to advance AZR-MD-001 in our ongoing Phase 3 program, where we hope to replicate the clinical benefit we observed in our first confirmatory efficacy study so we can quickly get it through the regulatory process and into the hands of patients. We anticipate having results from this study in the first half of 2024, which if positive, would support a New Drug Application (NDA), bringing us closer to having AZR-MD-001 0.5% available for patients like you, and the folks who signed the petition."

Thank you all for your support and efforts in this, I wish you all health and wellness as we continue this struggle going forward. 

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