Camurus Discloses Second Complete Response Letter for Oclaiz, Both Tied to the Same Manufacturer Inspection
Camurus said on June 10 that the FDA had issued a Complete Response Letter on the Oclaiz (CAM2029) NDA, the second the program has received and the second based solely on unresolved observations from a September 2024 cGMP inspection at a third-party contract manufacturer. The CRL did not cite clinical efficacy or safety. Camurus expects to resubmit in Q4 2026 with a second validated manufacturer; an approval pushed to the first half of 2027 leaves the US launch about a year behind the EU and UK rollouts (under the Oczyesa brand) that landed in 2025.