Cataract surgery sublingual sedation candidate meets primary endpoint in phase 2 trial
Click Here to Manage Email Alerts
MELT-300, a combination of midazolam and ketamine administered sublingually before cataract surgery, achieved the primary sedation endpoint in a pivotal phase 2 efficacy and safety study, Melt Pharmaceuticals announced in a press release.
The trial evaluated MELT-300 against placebo, as well as midazolam alone and ketamine alone. The primary efficacy endpoints were appropriate cataract surgery sedation and management of intraoperative pain during cataract surgery.
Source: Adobe Stock.
MELT-300 was superior to all comparator arms for procedural sedation. In addition, participants who received MELT-300 were 50% less likely to require rescue sedation compared with midazolam.
The product candidate also demonstrated a favorable safety profile.
“The clear, critical and positive findings for our procedural sedation primary endpoint allow us to confidently proceed with the development of this non-IV option for cataract surgery,” Larry Dillaha, MD, CEO of Melt Pharmaceuticals, said in the release. “We believe the commercial appeal for offering patients and physicians the ability to achieve adequate sedation without the need to start an IV is an extremely attractive option for the nearly 5 million cataract surgeries performed every year in the U.S. and the more than 20 million cataract surgeries performed around the world each year.”
Read more about
Click Here to Manage Email Alerts