Second Sight Medical (EYES) Announces FDA Expedited Access Pathway Designation for Orion Cortical Visual Prosthesis System

November 8, 2017 8:02 AM EST

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Second Sight Medical Products, Inc. (NASDAQ: EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Expedited Access Pathway designation for the Orion™ Cortical Visual Prosthesis System (Orion). This designation is given to a few select medical devices in order to provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review.

The FDA has also released a draft guidance document for a Breakthrough Devices Program, which, when finalized, will supersede the Expedited Access Pathway. FDA has indicated that all devices which have EAP designation will gain Breakthrough Device designation when the guidance document is finalized.

With this designation, Orion will have the following advantages during the FDA review process:

  • Greater interactive review both for the Investigational Device Exemption and Premarket Approval application;
  • Greater reliance on post-market vs. pre-market data collection and greater acceptance of uncertainty in the benefit-risk profile at the time of approval;
  • Priority review (i.e., review of the submission is placed at the top of the review queue and receives additional review resources); and,
  • Senior FDA management involvement and assignment of a cross-disciplinary case manager

“These advantages potentially allow the FDA to approve Orion with fewer patients and with a shorter follow-up timeline, thus facilitating a faster entry of Orion into the commercial market. We are delighted about the opportunity for patients to have expedited access to Orion, once approved,” stated Will McGuire, President and Chief Executive Officer of Second Sight.

Dr. Robert Greenberg, Chairman of Second Sight stated, “FDA’s Expedited Access Pathway is a game changer for nearly all blind individuals in the U.S. who currently have no treatment options. We look forward to moving the program ahead and working with the FDA in the coming months to map out the most efficient path to market for this therapy, which has the potential to treat most causes of blindness.”

Blind patients interested in the Orion clinical trial can contact Second Sight customer service at 1-855-756-3703 for further information or referral to one of our clinical trial sites.

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