First patient dosed in Melt’s phase 3 program of needle- and opioid-free cataract sedation
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Key takeaways:
- MELT-300 is a combination of midazolam and ketamine under investigation for cataract surgery sedation.
- Melt Pharmaceuticals expects topline results later this year.
The first patient has been dosed in a pivotal phase 3 program of a needle- and opioid-free sedation for cataract surgery, according to a press release from Melt Pharmaceuticals.
MELT-300, the company’s lead product candidate, combines fixed doses of midazolam 3 mg and ketamine 50 mg administered sublingually as a rapidly dissolving tablet.
Image: Adobe Stock
“As we mark this significant milestone in our phase 3 program, we’re not just advancing a medication; we believe we’re pioneering a paradigm shift in procedural sedation. MELT-300 represents our commitment to redefining patient care, offering a needle- and opioid-free solution that could hold immense promise for enhancing both safety and comfort in medical settings,” Melt CEO Larry Dillaha, MD, told Healio. “Our market research has shown that eye care professionals value the seamless simplicity that sublingual medication brings to their workflow, allowing them to skip the IV and focus on what truly matters — restoring clarity to their patients’ vision.”
The randomized, double-masked, three-arm clinical trial will evaluate the safety and efficacy MELT-300 compared with sublingual midazolam and sublingual placebo for procedural sedation in 528 patients undergoing cataract surgery at 14 clinical sites.
A previous phase 2 clinical trial found that MELT-300 was statistically superior for procedural sedation compared with placebo, midazolam alone and ketamine alone.
Melt expects topline results for the phase 3 trial later this year.
Editor’s note: This article was updated on June 11, 2024, to include comments from Larry Dillaha, MD.
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