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Clinical Trials
5
0 active
Approvals
1
Total approvals
Agencies
Regulatory bodies
Founded
N/A
Recruiting
20.0%
Terminated
4
80.0%
CIMA_AEMPS
Spanish Agency for Medicines and Medical Devices
- SeaBeLife and Unither Pharmaceuticals have formed a joint development agreement to accelerate the pharmaceutical and regulatory preclinical development of SBL03, an investigational topical ophthalmic formulation targeting geographic atrophy and dry age-related macular degeneration. - SBL03 represents a first-in-class dual inhibitor of necroptosis and ferroptosis pathways that demonstrated significant protection of retinal structural and functional integrity in preclinical animal models of induced retinal degeneration. - The partnership covers development and industrial scale-up, manufacturing of preclinical and GMP batches, analytical development, and preparation of CMC applications for regulatory submission, with clinical trials scheduled to begin in 2027. - The topical delivery approach offers a promising alternative to current intravitreal injection treatments, potentially transforming the management of severe retinal diseases through non-invasive eye drop administration.