IVERIC bio, Inc. is committed to developing safe and effective therapies for patients with retinal diseases with significant unmet medical needs.
We believe that the most effective way of achieving this goal is through establishing the benefit/risk profile of our drug product candidates through adequate and well-controlled clinical trials, followed by regulatory approval and commercialization. Patients in need of an investigational product that has not yet been approved are therefore encouraged to participate in one of our clinical trials.
Expanded access refers to the use, outside of a clinical trial, of an investigational drug that is intended to diagnose, prevent or treat a serious condition or immediately life-threatening disease and for which no alternative treatments are available. Expanded access use is usually requested by physicians on behalf of their patients for whom participating in a clinical trial is difficult or impracticable. IVERIC bio understands the need for expanded access and having an established program for these kinds of requests.
At this time, IVERIC bio believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs. If you wish to seek expanded access to one of our drugs, please have your physician contact us with a formal request at email@example.com. We anticipate acknowledging receipt of requests sent to this email within five business days.
In evaluating expanded access requests, IVERIC bio generally will consider the following factors:
- The seriousness of the disease for which expanded access is requested and the availability of alternative treatment options, such as approved products, if any, or other products that are recruiting patients for clinical trials
- The evidence of the potential benefit to the patient versus the potential risks to the patient, based on the available safety and efficacy information at the time
- The ability for us and our manufacturers to provide the product on a fair and timely manner to the patient and for our other ongoing programs
- Whether granting expanded access would potentially compromise the scientific validity of our development programs, or interfere with or delay current clinical trials or regulatory filings for the drug
Please keep in mind that, in accordance with law, we have the discretion to grant or deny a request for expanded access. Also, even if we grant expanded access for a particular instance, expanded access use will be subject to FDA review and approval.
Policy updated April 2020. In line with the 21st Century Cures Act, IVERIC bio may revise this policy at any time.