About Early Access Programs*
Early Access Programs* can only take place if it is allowed within the local laws, rules and regulations or specifically approved in writing by local authorities.
The physician and the patient should discuss the expected benefits, known risks and potential unknown risks before seeking Early Access to a medicinal product.
GenSight Biologics considers granting early access to its investigational products when all the following criteria are met:
- The product is not approved for the requested indication in the country where the request comes from;
- A patient is diagnosed with a serious and/or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available to treat the disease or condition;
- There is no alternative option for the patient to participate in an active clinical trial in the given indication;
- Sufficient medical data exists where the potential benefits of the treatment outweigh the potential risks for the disease to be treated, and the medicinal product has started the regulatory process of approval in the US and/or the EU;
- There is adequate supply of the investigational product, and providing the investigational product will not interfere with ongoing clinical trials or the overall development program; and
- Investigational access provided in this setting is allowed per local laws and regulations.
DISCLAIMER: Early Access Treatment can only be provided within limited circumstances, meaning that GenSight Biologics will not be able to fulfill all requests. After receiving a physician’s request, we commit to providing a timely response and a clear rationale for the decision. Due to Early Access regulations, patients themselves may not make a request for treatment and always need to contact their Licensed Treating Healthcare Professional.
*Other terms commonly used: Compassionate Use Program, Early Access Program, Expanded Access Program, Managed Access Program, Patient Access Program, Special Access Program, Scheme Access Program, Temporary Use Authorization and Pre-Approval Access.
US Public Policy Statement 2026
An Expanded Access Program (EAP) is intended to allow patient access to an investigational medicine for a serious or immediately life-threatening disease or condition where no comparable or satisfactory alternative therapy exists and when the potential benefit of the medicine justifies the potential risks and those risks are not unreasonable in the context of the disease or condition being treated.
All requests for access to a GenSight Biologics’ investigational drug, including those under the Right-to-Try Act as described in the US Federal Food, Drug & Cosmetic Act (FFDCA) section 561B “Investigational Drugs for Use by Eligible Patients”, need to be sponsored by a health-care professional.
Only qualified Physicians may make requests for Early Access to medinfo@gensight-biologics.com, and only once they have exhausted all other appropriate and available options to treat the medical condition of their patient, including enrollment in a clinical trial.
When the request is received by GenSight Biologics, GenSight Biologics will send an acknowledgement of receipt of the request, and its medical department will then assess the requests on a case-by-case basis, considering requests in a fair, compassionate, and thoughtful manner. GenSight Biologics may agree to provide an investigational medicine to the physician only if:
- The conditions for Early Access are met;
- The company agrees with the physician’s medical evaluation that the possible benefits of the drug outweigh the potential risks; and
- There is adequate product availability.
If the request for Early Access is approved by GenSight Biologics, the physician must collect and complete all necessary documents to comply with appropriate rules and regulations. Once the regulatory approvals are granted, GenSight Biologics will supply the product in accordance with the relevant local regulations.
The physician must commit to the regulatory obligations including reporting of adverse events during the entirety of the Early Access.
GenSight Biologics follows FDA regulations and guidance that describe criteria that must be met to authorize expanded access and list requirements for expanded access submissions. The list of GenSight Biologics’ Early Access Programs in the United States is available on www.clinicaltrials.gov.
Information applicable to all territories outside of France and the United States
GS010/LUMEVOQ® Early Access Programs
Early Access, also referred to as “Compassionate Use” and “Expanded Access”, depending on the country, is the treatment of a patient with an investigational medicinal product (that is, one that has not been granted marketing authorization by regulatory agencies such as the Food and Drug Administration [FDA], European Medicines Agency [EMA] and the Medicines and Healthcare products Regulatory Agency [MHRA]). It is granted after the relevant regulatory authority reviews a request by a physician to treat a patient with the candidate product. In general, and subject to product availability and the requisite regulatory approval, GenSight Biologics is supportive Early Access Programs (EAPs), as they could be an important option for patients with high unmet medical needs to access to investigational medicines prior to marketing authorization of those products.
GenSight Biologics considers requests from physicians on a case-by-case basis after the physician has evaluated all options for the patient, including participation in a clinical trial. In accordance with early access regulations, only physicians may inquire about early access treatments. Such inquiries should be sent to: medinfo@gensight-biologics.com.
All inquiries and communications sent to this email address will be treated with the strictest confidence, and any personal data contained therein will be processed in accordance with applicable data protection laws.
