Roca Therapeutics receives orphan drug designation for radiation maculopathy
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Published on September 17, 2025
–
Updated on September 17, 2025
Dates
on the September 4, 2025
French start-up Roca Therapeutics announces that its drug candidate RCT002 has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for the treatment of radiation maculopathy, now recognized as a disease in its own right.
In INSIGHTS magazine n°3, Roca Therapeutics indicated that it was preparing a request for scientific advice from the EMA in order to initiate clinical trials. This step has now been successfully completed, marking official recognition and paving the way for the next phase of development.
Radiation maculopathy causes vision loss following radiotherapy for uveal melanoma, head and neck cancer or brain tumors. No standard treatment exists today.
RCT002, a first-in-class eye drop developed over two years, targets resistant neovascularization, inflammation and oxidative stress, offering an innovative approach to current treatments. Clinical trials are scheduled for 2026.
Co-founded in 2021 by academic researchers - Cyril Ronco and Rachid Benhida (ICN), Gilles Pagès and Maeva Dufies (IRCAN), Stéphanie Baillif (CHU de Nice) - and Landmark BioVentures AG, Roca Therapeutics develovelopment of small topical molecules designed to transform the management of retinal diseases and meet medical needs that have hitherto been poorly covered. The start-up was supported by the IdExInnovation Program of the Université Côte d'Azur through its "Start-Up Deeptech" and "Partenariat Innovation" calls for projects, notably for the RCT002 development.
Read the press kit
Radiation maculopathy causes vision loss following radiotherapy for uveal melanoma, head and neck cancer or brain tumors. No standard treatment exists today.
RCT002, a first-in-class eye drop developed over two years, targets resistant neovascularization, inflammation and oxidative stress, offering an innovative approach to current treatments. Clinical trials are scheduled for 2026.
This recognition paves the way for targeted treatments and greater access for patients whose vision deteriorates after radiotherapy," emphasizes Zaki Sellam, President of Roca Therapeutics.
Co-founded in 2021 by academic researchers - Cyril Ronco and Rachid Benhida (ICN), Gilles Pagès and Maeva Dufies (IRCAN), Stéphanie Baillif (CHU de Nice) - and Landmark BioVentures AG, Roca Therapeutics develovelopment of small topical molecules designed to transform the management of retinal diseases and meet medical needs that have hitherto been poorly covered. The start-up was supported by the IdExInnovation Program of the Université Côte d'Azur through its "Start-Up Deeptech" and "Partenariat Innovation" calls for projects, notably for the RCT002 development.
Read the press kit
