Celairis Therapeutics has secured exclusive rights to commercialise Ocugen's investigational gene therapy for retinitis pigmentosa in Australia, New Zealand and the member states of the Association of Southeast Asian Nations.
The licence covers OCU400, a modifier gene therapy Ocugen is developing for the group of inherited retinal diseases that cause progressive vision loss and, in many cases, blindness. The agreement gives Celairis access to a potential one-time treatment across a region with an estimated 725 million people, subject to approval in the United States.
Under the deal, Ocugen will receive an upfront licence fee and development and milestone payments of up to US$7.1 million. Of that, US$6.1 million is tied to the upfront payment and topline results from the OCU400 program, expected in the first quarter of 2027. Ocugen will also receive a high-single-digit royalty on net sales and half of the gross profits from OCU400 sales in the region.
The two companies expect to sign a supply agreement under which Ocugen will manufacture and supply the therapy. Celairis will handle regulatory submissions, market access and commercialisation across the territory.
Ocugen chairman, chief executive and co-founder Dr Shankar Musunuri said the region needed a local partner.
"Australia, New Zealand, and ASEAN are large, diverse and complex markets, and establishing a partnership with a regional company like Celairis and its strong local network is critical to our goal of global patient access," Dr Musunuri said.
"This agreement marks our third strategic regional partnership for OCU400, underscoring the growing momentum behind our global access strategy and bringing our potential one-time treatment gene therapy closer to patients around the world."
Ocugen is running the Phase 3 liMeliGhT trial. After topline data in early 2027, it plans to file globally, including a Biologics License Application in the United States and a Marketing Authorisation Application in Europe. Submissions in Celairis' territory are expected to follow.
Celairis chief executive, co-founder and managing director Matt Zeller said the program suited the company's model.
"Ocugen is the kind of partner Celairis was built for: a late-stage program, a clear strategy for reaching patients globally, and a conviction we share that geography should not decide access to new medicines," Mr Zeller said.
"Celairis brings the development, regulatory, and market access capability to do that across our region, and we look forward to building the relationship with Ocugen."