FORM 8-K

CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): November 2, 2017

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events

On November 2, 2017, Second Sight Medical Products, Inc. (the “Company” “or “we”) issued a press release announcing the receipt of the U.S. Food and Drug Administration (FDA) full approval to begin the Orion™ Cortical Visual Prosthesis System (Orion) feasibility clinical study. On August 28, 2017, the Company announced that the FDA had granted conditional approval, requesting the Company answer additional questions and perform additional tests. We now have completed those additional tests, answered those additional questions, and received a full approval from the FDA.

The Orion converts images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes implanted on the surface of the visual cortex of the brain, intended to result in the perception of patterns of light. Orion, by bypassing the retina and optic nerve and directly stimulating the visual cortex, has the potential to restore useful vision to patients completely blinded due to many reasons, including glaucoma, diabetic retinopathy, or forms of cancer and trauma.

The Company conducted a proof-of-concept clinical trial demonstrating the viability of stimulation of the human visual cortex with a commercially available device from a different manufacturer in Q3 2016 at the University of California at Los Angeles (UCLA).

The approval allows two U.S. sites to enroll up to five total patients. The Company has designated UCLA and Baylor College of Medicine in Houston as the U.S. clinical trial sites.

A copy of our press release entitled “Second Sight Receives Full FDA Approval to Begin First Orion Human Clinical Study” is attached as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 6, 2017

SECOND SIGHT MEDICAL PRODUCTS, INC.