Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 5

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 5
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avenous, sedation
and anesthesia therapeutics for human medical procedures in hospital, outpatient, and in-office settings. Melt is seeking regulatory
approval for its proprietary technologies, where possible. 

MELT-300
is a novel, sublingually delivered, non-IV, opioid-free drug candidate being developed for procedural sedation. In November 2024, Melt
announced data from, and the successful completion of, its pivotal Phase 3 study for MELT-300. The MELT-300 pivotal Phase 3 clinical
trial was a randomized, double-blind, three-arm study comparing, at a 4:1:1 ratio, MELT-300, sublingual midazolam, and sublingual placebo,
respectively, for procedural sedation in patients undergoing cataract surgery. The study was conducted at 13 clinical sites in the U.S.
and enrolled over 530 patients. Results from the clinical study are summarized below:

·MELT-300
                                            achieved its primary procedural sedation endpoint, demonstrating statistical superiority
                                            for procedural sedation compared to all comparator treatment arms, including midazolam 3mg
                                            (P=0.009) and placebo (P<0.001).

·Using
                                            the validated Ramsey Sedation Scale (RSS), MELT-300 treatment arm patients were 50% less
                                            likely to require rescue sedation compared to midazolam 3mg (P=0.0198).

·Proportion
                                            of patients requiring rescue sedation was nearly two-fold higher for sublingual midazolam
                                            compared with MELT-300 (P=0.003).

·MELT-300’s
                                            safety profile was generally comparable to the placebo arm.

The
Phase 3 study was conducted following the successful completion of the MELT-300 Phase 2 clinical trial in patients undergoing cataract
surgery, which compared MELT-300 against (i) sublingual placebo alone, (ii) sublingual midazolam, and (iii) sublingual ketamine in over
300 patients. MELT-300 was statistically superior for procedural sedation compared to all individual comparator arms: (i) sublingual
placebo (P<0.0001), (ii) sublingual midazolam (P=0.0129), and (iii) sublingual ketamine (P