Trial Profile

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 20 Aug 2026

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At a glance

10 Aug 2026 According to a Harrow media release, The FDA granted a pre-NDA meeting with Harrow which will help finalize the regulatory strategy toward an NDA submission.
02 Feb 2026 According to Harrow media release, company remains on track to submit the NDA for MELT-300 in the first half of 2027.
18 Nov 2025 According to a Harrow media release, the Melt Pharmaceuticals has been acquired and merged into Harrow.

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