Mitro Named President & Chief Executive Officer, Readies Pro-ocular for Phase 3 Trials

The company's breakthrough drug is the first product for Dry Eye Disease (DED) to utilize transappendageal forehead delivery and the only product to treat DED by targeting the ophthalmic branch of the trigeminal nerve.

GREENWICH, Conn., Aug. 13, 2024 /PRNewswire/ -- Spencer Trask & Co. (Spencer Trask), the advanced technology development firm, announced today the launch of Signal12 Inc. (Signal12), a clinical-stage dry eye company. Signal12 is revolutionizing treatments for Dry Eye Disease (DED) and eliminating the hassle of eye drop instillation with its first-of-a-kind, patented technology that enables existing drugs to act through unique neural pathways.

Signal12's breakthrough topical drug, Pro-ocular, is the first product in eyecare to utilize transappendageal forehead delivery (drug delivery via hair follicles or sweat glands in the skin) and the only product to treat DED by targeting the ophthalmic branch of the trigeminal nerve. Pro-ocular, when applied to the forehead twice daily, has been shown to be safe and effective for DED of all severity levels. This has been demonstrated through three separate Phase 2 clinical studies. Signal12 licensed the Pro-ocular intellectual property, which included 89 patents that cover 49 countries, from Glia LLC, which is a Spencer Trask venture.

Thomas Mitro was recruited by Spencer Trask to lead Signal12 as president and chief executive officer. Mitro is the former president and chief operating officer of Aerie Pharmaceuticals, where he grew annual sales to more than $100 million and facilitated a $770 million acquisition by Swiss eye-care firm Alcon. Prior to Aerie, Mitro built and led the commercial operations function at ISTA Pharmaceuticals, which was acquired by Bausch & Lomb. He also spent 24 years at Allergan in multiple leadership roles.

"I am honored to lead Signal12 in its mission to transform the landscape of ocular health," said Mitro. "The company's pioneering technology and impressive clinical data for Pro-ocular make it a game-changer in treating dry eye disease. I am eager to leverage our team's extensive experience and push forward with our Phase 3 trials. The eye health market is ripe for innovation, and Signal12 will play a crucial role in addressing unmet needs and improving the lives of millions affected by ocular conditions."

The Signal12 management team, board of directors and scientific advisors have decades of experience in ophthalmic product development, FDA and EU submissions, approvals, and market commercialization.

Joining Mitro is former Aerie executive Marvin Garrett as senior vice president of regulatory affairs and safety. Garrett has four decades of experience in the healthcare industry, having held senior leadership positions at many of the leading ophthalmology firms in the United States. During his career, Garrett spearheaded efforts to gain approval for over 60 marketing applications.

Pamela F. Gallin, M.D., F.A.C.S., will serve as the medical director for Signal12. Dr. Gallin is one of the highest-ranking surgeons at NY Presbyterian where she is a Clinical Professor of Ophthalmology at the Edward Harkness Eye Institute of NY Presbyterian Columbia University Medical Center. She is an examiner for the American Board of Ophthalmology, a Heed Foundation Fellow, and was a member of the White House Task Force on Medicine under Hillary Clinton.

Neil Edwards was appointed as the company's chief financial officer. Edwards is an accomplished financial leader with over 25 years of global experience in healthcare, generative AI, supply chain risk management, and technology—in chief operations officer, CFO and board director roles. He has been instrumental in achieving significant milestones, including architecting a strategic AI acquisition that increased the valuation of a Spencer Trask portfolio company from $8 million to $1 billion.

The company is governed by a board of directors who are proven business leaders and eye-care industry veterans. In addition to Mitro and Edwards, the Signal12 Board includes Vincent Anido, PhD, former chairman and chief executive officer, Aerie Pharmaceuticals; Robert Dempsey, president and chief executive officer, AsclepiX Therapeutics; James Mazzo, executive chair and board of directors, Neurotec Pharmaceuticals; Kenneth Sawyer, chief executive officer and co-founder, Glia LLC; and Kevin Kimberlin, chairman, Spencer Trask & Co.

Signal12 is committed to advancing patient care and easing the burden of living with DED. With an estimated 18 million Americans diagnosed with DED, the company's work is critical for improving the lives of patients grappling with this debilitating ocular condition.

About Signal12 Inc.
Signal12 is a clinical-stage dry eye company that develops novel therapies to address ophthalmic diseases. Through three Phase 2 clinical studies, the company's proprietary topical drug, Pro-ocular, has demonstrated efficacy in safely and effectively reducing the signs and symptoms of dry eye disease (DED). Pro-ocular is the first product for DED to utilize transappendageal delivery, and the only product to treat DED by targeting the ophthalmic branch of the trigeminal nerve. The company has offices in Greenwich, CT and Boston, MA.

SOURCE Spencer Trask & Co.