Clinical-stage regenerative medicine company Cambium Bio (ASX:CMB) has announced that the US FDA has approved the protocol for the registration-enabling Phase 3 clinical trials of Elate Ocular for the treatment of moderate to severe dry eye disease.
The FDA recently granted Elate Ocular a fast-track designation for dry eye disease.
The company said the Phase 3 program consists of two identical registration-enabling trials (CAMOMILE-2 and CAMOMILE-3). The trials will be conducted as a Multi-Regional Clinical Trial (MRCT) across sites in Australia, the US, and select other countries. Each trial will enrol 400 patients with moderate to severe dry eye disease. The co-primary endpoints are signs of change in the total corneal fluorescein staining score and eye discomfort score.
CEO Karolis Rosickas said, "FDA approval of our Phase 3 protocol marks a pivotal milestone in Elate Ocular's development journey. The trial design reflects extensive consultation with regulatory experts and key opinion leaders to ensure we meet the FDA's requirements for registration. With Fast Track designation now secured and the protocol approved, we are well-positioned to advance Elate Ocular through its final stages of clinical development."