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Expanded Access Program

Ocular Therapeutix, Inc.’s Expanded Access Program

This program is intended for patients with serious or life-threatening conditions who do not have any viable or available treatment options and are unable to participate in ongoing clinical trials. (To view a list of Ocular Therapeutix, Inc.’s (Ocular) open clinical trials, visit clinicaltrials.gov).

Ocular’s Expanded Access Program (EAP) is limited to individual or single patient expanded access use in the United States. To ensure patient safety, we have developed certain criteria to evaluate EAP requests. Ocular is committed to reviewing each request carefully and fairly, but we cannot guarantee access to any investigational product by any individual patient.

Note that EAP requests must be initiated by a treating physician; if you are a patient or caregiver, please ask your physician to send the EAP request, along with relevant information, to: Regulatory@ocutx.com. Ocular will acknowledge receipt within five business days, and its representatives (including medical, clinical development, regulatory and legal) will convene promptly to review submitted information and determine if the EAP request is suitable for the patient.

The following criteria must be met and evidence of the same provided to Ocular for an EAP request to be granted:

  1. The treating physician has evaluated the benefit-risk profile of the investigational drug prior to patient treatment and has determined that the probable risk to the patient from the investigational therapy is not greater than the probable risk from the patient’s disease or condition.
  2. The treating physician has confirmed and documented a legitimate medical need, including that the patient’s disease or condition is serious or life-threatening; there are no available alternative treatments; AND there is no clinical trial, whether Ocular’s or another company’s, in which the patient may enroll.
  3. The treating physician making the EAP request holds appropriate qualifications (background, education, experience, and expertise) to carry out the treatment.
  4. The treating physician agrees to assume all responsibilities and obligations to comply with relevant regulatory and professional requirements.
  5. Ocular has determined that providing the investigational medical product will not interfere with or compromise its clinical development program.

Additional Steps:

  • If Ocular determines that a single-patient, expanded access, investigational new drug (IND) use (outside of a clinical trial) is appropriate based on the above criteria, it will issue a Letter of Authorization (LoA) to the treating physician to reference the existing IND under which the investigational drug is being studied.
  • The treating physician, in coordination with Ocular, will gather and submit all necessary documentation (including an informed consent document) to the IRB for review of the proposed EAP treatment and related documentation.
  • If the IRB approves, the physician then submits the LoA along with Form 3926 to the FDA.
  • The expanded access IND will go into effect 30 days after the FDA receives the application, unless the FDA allows treatment to proceed before then (emergency expanded access request) or the FDA puts the application on clinical hold.
  • Once the FDA has agreed to expanded access use, Ocular will provide a contract to be executed by the treating physician, patient, and Ocular before Ocular may release the investigational drug.