We are Highly Experienced in all Aspects of Eyecare

Focused on the discovery, development, and commercialization of novel, first-in-class therapies to address ophthalmic disease.

Signal12 was founded by two Pharmaceutical industry veterans after one of them urgently needed an innovative eye treatment during a herpetic attack. This pivotal moment led to the discovery of a unique delivery approach using the forehead’s keratinocyte-rich environment, which proved effective in delivering progesterone and stabilizing the ocular infection. The breakthrough paved the way for development of the company’s flagship product, Pro-ocular™.

Mission

Novel Ocular Health Solutions

We’re committed to revolutionizing ocular health through innovative treatments and groundbreaking research.

We began with a vision to address the unmet needs of patients suffering from ocular diseases, and today, we’re on the road to bringing to market our breakthrough cranial signaling oGvHD solution that will transform lives of those living with that devastating disease.

Through ongoing investor-funded trials and global partnership discussions, Signal12 is advancing innovative solutions for ocular surface diseases, offering hope to patients worldwide.

Milestones

Our Phase 2 trial at Harvard University affiliated Mass Eye and Ear with The Dana-Farber Cancer Institute demonstrated the efficacy of our Pro-ocular™ gel product in ocular Graft versus Host Disease (oGvHD) patients post-stem cell transplantation. Published in “Transplantation and Cellular Therapies,” the study revealed statistically significant and clinically meaningful improvements in signs and symptoms, with sustained results over two years.

Meet the Team

Our founders discovered and developed neural/cranial delivery; initially demonstrated to treat CNS neurodegenerative and ocular diseases, and then expanding to selected parasympathetically innervated organ systems.

Executive Leadership

Tom Mitro

President & CEO
  • 30+ years of pharmaceutical industry experience
  • Fmr. President & COO, Aerie Pharmaceuticals (acquired by Alcon), where he grew its annual sales to over $100 million
  • Started and led the commercialization efforts at ISTA Pharmaceuticals, and grew its annual sales to over $165 million
  • 24 years at Allergan in multiple leadership roles

Marv Garrett

SVP, Regulatory Affairs & Safety
  • Four decades of experience in the healthcare industry
  • Senior executive for many of the leading ophthalmology firms in the U.S.
  • 60+ drug approvals for Allergan, Alcon, Bausch & Lomb, and more
  • Extensive knowledge pertaining to all areas of regulatory and FDA relations, quality, clinical research and operations and compliance

Pamela F. Gallin, M.D., F.A.C.S

Medical Director
  • One of the highest ranking surgeons at NY Presbyterian
  • Clinical Professor of Ophthalmology at the Edward S. Harkness Eye Institute of NY Presbyterian and Columbia University Medical Center
  • Director Emeritus of Pediatric Ophthalmology and Adult Strabismus
  • Examiner for the American Board of Ophthalmology Board Examination
  • Member of the White House Task Force on Medicine under Hillary Clinton
  • Heed Foundation Fellow

Wei Wei Chang, PhD

CSO & Co-founder
  • 40+ years of pharmaceutical industry experience
  • Held senior management positions at Lederle and Warner-Lambert, both of which were acquired by Pfizer
  • Founding member of Rhodes Pharmaceutical, Anchen Pharmaceuticals, and Bharat Pharmaceutical
  • Rebuilt the Copley Pharmaceutical product pipeline, enabling its sale to Teva
  • Developed numerous drug products, new chemical entities, and generic drug formulations
  • Co-developed first generic dronabinol for market

Kenneth Sawyer

CTO & Co-Founder
  • 45 years of pharmaceutical industry experience
  • Former CEO of a publicly traded pharmaceutical company
  • Represented the Pharmaceutical industry in front of the FDA, US Attorneys Office, and Congress
  • Chartered policies to legitimize generic drugs in the U.S.
  • Worked with the Clinton/Gore administration on implementing changes to health care
  • Co-developed the first generic dronabinol for market

Neil Edwards

CFO
  • Senior C-suite leader who completed 60+ transactions for public and venture backed companies, including Verisign and infoGroup
  • Secured investments from Google, Vodafone, Visa, and Samsung as CEO of dotMobi
  • Led the Kleiner Perkins funding round as CRO of Interos.ai

Board of Directors

Tom Mitro

President & CEO, Signal12

Kenneth Sawyer

CTO, Signal12, Co-founder, Glia LLC

Kevin Kimberlin

Chairman, Spencer Trask & Co.

Vince Anido, PhD

Fmr. CE, Aerie Pharmaceuticals

James Mazzo

Executive Chairman, Neurotech, Inc.

Robert Dempsey

President & CEO, AsclepiX Therapeutics, Inc.

Scientific Advisors

Francis Mah, MD

Scripps Clinic Medical Group, Director of Cornea and External Disease,
Co-Director Refractive Surgery

Sam Garg, MD

UC Irvine, Vice Chair, Ophthalmology

Jim Tsai, MD

Mount Sinai, Dept. Chair Ophthalmology

Katie Luo, MD, PhD

Mass Eye & Ear, Physician and Surgeon
Assistant Professor, Harvard Medical School

Stanley Chang, MD

Columbia University, Dept. Chair Ophthalmology

Join Our Mission

Signal12 is planning to facilitate Phase 3 clinical trials in 2025 and bring Pro-ocular™ to market.

Contact Us Today

Pro-ocular™
Clinical Trials
Company
Leadership

Signal12 Inc.

Signal12 is a Phase 3-ready ophthalmic drug company. Our proprietary topical drug, Pro-ocular™, has proven safe and effective in Phase 2 clinical studies, demonstrating significant reductions in the signs and symptoms of ocular Graft-versus-Host Disease (oGvHD)—a chronic, debilitating condition following an allogeneic stem cell transplant. Pro-ocular™ is the only effective treatment for oGvHD, employing transappendageal delivery to precisely target the ophthalmic branch of the trigeminal nerve

Signal12 is actively raising capital to complete its Phase 3 clinical trials and bring Pro-ocular™ to market. For information on investment opportunities, please email Neil Edwards at [email protected]. The company has offices in Greenwich, CT and Boston, MA.

© 2025 Signal 12 Inc. | Email: [email protected]