Clinical Trials
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Approvals
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Total approvals
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- Harrow announced the acquisition of Melt Pharmaceuticals, which developed MELT-300, a sublingual sedation therapy combining midazolam and ketamine for non-opioid procedural sedation. - MELT-300 demonstrated statistical superiority over sublingual midazolam alone (P=0.009) and placebo (P=<0.0001) in the pivotal LOUISE Phase 3 study for successful procedural sedation. - The acquisition positions Harrow to enter the multi-billion-dollar U.S. procedural sedation market with plans for FDA submission in 2027 and potential commercial launch in 2028. - Harrow's existing experience with MKO Melt, used in over 500,000 cataract surgeries by more than 700 ophthalmologists, provides a foundation for MELT-300's market introduction.
- Alfredo Sadun, MD, addressed the challenges of aging clinicians in ophthalmology, highlighting the complexities of assessing competency and avoiding ageism. - Jennifer Loh, MD, presented data on CSF-1, a low-dose pilocarpine drop, demonstrating a 30% mean reduction in pupil size and improved near visual acuity without affecting distance vision. - Brent Kramer, MD, discussed the benefits of the MKO Melt for cataract surgery, emphasizing improved patient and team experience due to its opioid-free, needle-free approach. - Researchers at Wilmer Eye Institute found that increased ANGPTL4 may counteract anti-VEGF therapy in wet AMD and that experimental drug 32-134D could enhance treatment efficacy.
