MALVERN, PA — Ocugen Inc. (NASDAQ: OCGN) has established a European affiliate in Amsterdam and appointed former Moderna Netherlands executive Jolanda Crombach to lead it, positioning the Malvern biotechnology company for potential regulatory approvals and commercialization of three experimental gene therapies for retinal diseases.
The expansion comes as Ocugen advances three Phase 3 clinical programs toward planned regulatory submissions in the United States and Europe, with key trial results expected in 2027 and 2028.
Crombach will serve as general manager of the newly established European operation, overseeing the development of personnel and infrastructure needed to support regulatory and commercial activities.
The company plans to pursue European Marketing Authorization Applications following the anticipated clinical data readouts. Those submissions would be necessary steps toward securing permission to market the treatments in Europe.
Ocugen’s lead programs target three retinal conditions associated with vision loss: retinitis pigmentosa, geographic atrophy secondary to dry age-related macular degeneration, and Stargardt disease.
OCU400 is being developed for retinitis pigmentosa, a group of inherited retinal disorders that cause progressive vision deterioration.
OCU410 targets geographic atrophy associated with dry age-related macular degeneration, while OCU410ST is being evaluated for Stargardt disease, an inherited condition affecting the retina.
All three candidates use Ocugen’s modifier gene therapy approach and remain investigational. Their eventual commercialization depends on clinical results and regulatory review.
“As we advance our three Phase 3 modifier gene therapy programs toward regulatory submissions and potential commercialization, establishing a strong presence in Europe is an important component of our growth strategy,” said Shankar Musunuri, Ocugen’s chairman, chief executive officer and co-founder.
Crombach joins Ocugen after serving as managing director and a board member of Moderna Netherlands, where she established the company’s Dutch affiliate and subsequently managed its operations.
Her appointment brings experience in developing pharmaceutical operations within European healthcare markets, including commercial strategy, market access and medical affairs.
Before Moderna, Crombach held leadership positions at MSD, also known as Merck, and Pfizer, spanning commercial operations, market access, medical affairs and corporate and public affairs.
She began her career as a pharmacist and holds an MSc PharmD degree from Utrecht University in the Netherlands.
The Amsterdam affiliate will be responsible for building Ocugen’s regional organization as the company approaches clinical milestones and prepares for potential European regulatory submissions.
The expansion establishes a European operating presence before the company has secured marketing authorization for any of the three therapies covered by its late-stage development program.
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