Patients & Families
Our Commitment to Patients
At MeiraGTx, patients and their families are the cornerstone of everything we do. We are continually asking how our research and our therapies can potentially improve the lives of patients living with serious diseases. Each day, we work to improve the lives of patients through cutting-edge science designed to treat their specific disease with the best treatment possible.
To help us with this mission, we have established, and continue to build, strong relationships with patient advocacy groups around the world to understand how to best serve patients and their families. The clear lines of communication that flow to and from our patient advocates actively help inform and guide our research and clinical development decisions. These relationships also help patients and their families stay up-to-date on our clinical trial progress.
Find out more about our clinical trials by visiting www.clinicaltrials.gov and searching ‘MeiraGTx’ or by contacting us at patients@meiragtx.com, and learn more about our expanded access program by clicking here.
MeiraGTx is focused on developing potentially curative treatments for patients living with serious diseases. Our goal is to provide access to our product candidates at the appropriate time and in the correct manner for patients.
Expanded access refers to the use of a product candidate outside the auspices of a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient for which no alternative treatments are available. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. Expanded access use is usually requested by physicians on behalf of their patients for whom participating in a clinical trial is difficult or impracticable. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.
A number of factors consistent with the policies of the U.S. Food and Drug Administration (FDA) and guidelines of international regulatory agencies should be taken into account when considering expanded access. They include:
- The illness must be serious or life-threatening
- There are no other viable treatment options (such as approved products or enrolling clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on safety and efficacy information available at the time
- Ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
- Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay the conduct of current clinical trials or regulatory submissions designed to make the product candidate available to many more patients
At this time, MeiraGTx believes that participation in one of our clinical trials is the most appropriate way to access our product candidates. If you have additional questions, please speak with your physician or contact patients@meiragtx.com. We anticipate acknowledging receipt of requests sent to this e-mail within five business days.
Pursuant to the 21st Century Cures Act, MeiraGTx may revise this policy at any time.
Dated: February 2021
