Expanded Access Policy
Oculis is dedicated to developing new therapies that have a positive impact on patient health. In general, patients obtain access to investigational therapies prior to regulatory approval by participating in clinical trials. There may, however, be circumstances when patients with a serious or life-threatening illness have exhausted all available treatment options and are not eligible to participate in any appropriate clinical trials. In those cases, patients may be eligible for treatment with an investigational therapy through programs referred to as ‘Expanded Access Programs’ (EAPs) or ‘compassionate use’. These programs help provide patients with a treatment outside the clinical trial setting that they would otherwise not be able to receive.
For a patient to get access to a therapy via an EAP, a doctor must decide whether the potential benefit outweighs the risk of receiving an investigational or unapproved therapy, based on the individual patient’s medical history.
Our Policy
Oculis will consider a number of criteria – consistent with the US Food and Drug Administration (US FDA) and other regulatory agencies’ guidelines – when evaluating each request for access to our investigational therapies. Oculis will consider granting expanded access to an investigational medicine only if all of the following threshold criteria are met:
- Patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials, regulatory filings, or marketing approval for the treatment indication.
- Ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs.
What next?
If you are interested in obtaining access to an investigational medicine, you should discuss available options with your qualified treating physician. If an Oculis clinical trial may be a good treatment option for you, we recommend that your doctor contact us on your behalf at info@oculis.com to discuss your specific medical condition and trial eligibility requirements.
If you are not eligible for an open or pending clinical trial, or if no appropriate clinical trials exist, and if your qualified treating physician believes that an EAP may be the best or only treatment option for you, please ask your doctor to contact Oculis on your behalf at EAP@oculis.com. Requests must include patient medical history, diagnosis, and justification for Expanded Access.
Requests will be acknowledged within 5 business days of receipt. If after contacting Oculis, your doctor is supportive of and committed to the requested treatment, he/she must submit a formal request to Oculis for consideration.
Please note that submission of a request does not guarantee that access to the investigational therapy will be provided. Eligibility will be determined by Oculis based on the established EAP and eligibility criteria for the investigational therapy considered.
If the expanded access request is approved by Oculis, the country regulatory authority from where the request originated will need to grant final approval before Oculis can provide the investigational medicine to the requesting physician. If approved for an EAP, your physician will work with you to address all logistical elements.
In line with the 21st Century Cures Act, Oculis may revise this policy at any time.