Compassionate Use Policy
Aldeyra Therapeutics is committed to providing patients with access to our medicines. The best way for eligible patients to access our investigational products is through participation in our clinical trials. These trials are designed to establish whether a particular product candidate is safe and effective for use in a specific disease or condition. Once trials are completed, the information gained is submitted to regulatory authorities such as the U.S. Food and Drug Administration. These authorities review the information and determine if it meets standards for safety and effectiveness so that it can potentially be prescribed by physicians or other health care providers. However, patients who are not part of these trials who may benefit from the product and meet certain eligibility criteria (see below) can request access to the investigational product through their physician. These situations are typically referred to as expanded access programs (EAP) or compassionate use policy.
Procedure and Eligibility Criteria
Requests for access to Aldeyra’s investigational products must meet the criteria below:
- The patient has a serious or life-threatening condition
- The patient does not have access to comparable or satisfactory alternative therapies
- The patient does not qualify for, or have access to, any on-going Aldeyra clinical trials
- There is substantial scientific evidence to expect that the patient may derive a clinically meaningful benefit and that the investigational product will have an acceptable safety profile in the relevant indication to support a robust risk-benefit analysis
- There is substantial scientific evidence to support an appropriate dose (amount and frequency) for the investigational product
- The investigational product is under active development by Aldeyra, and access on an early access for individual use basis will not delay, interfere with, or compromise clinical trials or the possible regulatory approval for the product
- There is an adequate supply of the investigational product
- The compound can be administered – and it is logistically feasible to make it available – outside of the clinical trial setting
- Whether the relevant patient’s underlying medical conditions pose safety risks that have not been sufficiently studied
- The request has been made by a qualified and licensed physician in the United States with expertise and facilities appropriate for the administration of the therapy, monitoring, managing and reporting side effects, as well as patient experience
Requests for access by the treating physician should be made by contacting us here. Requests are typically acknowledged within five business days from when the request is received.
How Requests are Evaluated
Aldeyra is committed to a fair and impartial evaluation of each request for compassionate access to our investigational products. Decisions will be based on the criteria above. Use of all investigational products is subject to local regulatory and ethical reviews and approval, patient consent and treating physician agreement with any necessary safety monitoring and reporting. Aldeyra cannot guarantee that the investigational product will be available to a particular patient.
All decisions will be based on clinical and scientific factors that affect the benefits and risks to the individual patient.