Mark Mannebach, PhD, RPh.

NASHVILLE, Tenn—Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, announced the appointment of Mark Mannebach, PhD, RPh, as head of regulatory affairs and pharmacovigilance, responsible for overseeing and managing all regulatory related submissions and strategy related to the company’s portfolio of new and existing products. Dr. Mannebach’s successful 30-year career in the pharmaceutical industry, much of which was focused in ophthalmology, includes leadership roles in regulatory affairs, quality assurance, program management and pharmaceutical product development.

“Dr. Mannebach brings to Harrow decades of regulatory and clinical expertise and leadership—specifically in ophthalmology—that we believe will be invaluable as we continue to execute on our strategic plan to expand our branded ophthalmic product portfolio,” said Mark L. Baum, chairman and chief executive officer of Harrow. “We believe Mark’s deep industry knowledge, extensive experience interfacing with U.S. regulatory agencies, and his long history of developing and implementing effective regulatory processes to comply with FDA guidelines and applicable federal laws, will greatly benefit Harrow as we launch Iheezo, leverage our recent product acquisitions, and pursue new product acquisition and development opportunities.”

Dr. Mannebach added, “I am pleased to join the Harrow management team and be a part of the transformational events that are underway. I look forward to using my expertise and experience to strengthen Harrow’s regulatory and compliance commitments and to facilitate productive interactions with the FDA to best ensure that Harrow advances the standard of ophthalmic care and ultimately provides eyecare professionals and their patients with access to Harrow’s innovative pharmaceutical products.”

 
In addition to acting as a regulatory and compliance consultant to various start-up biotech companies, Dr. Mannebach’s previous roles included serving as the vice president of global regulatory affairs at both Mallinckrodt Pharmaceuticals and then Santen Pharmaceuticals. Earlier in his career, Dr. Mannebach held roles of increasing responsibility at Sanofi, Pharmacia, Baxter, and Pfizer.

Harrow is a U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies. Harrow owns U.S. commercial rights to 10 FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, a U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states.  

Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt.