A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)

Inclusion Criteria:

Participants must meet all of the following in order to be enrolled into the study:

1. Males and females ≥ 18 years of age

2. Are to undergo unilateral primary CELR under topical anesthesia, with aphacoemulsification device and insertion of an intraocular lens (no restrictions onlens type)

3. For women of childbearing potential (WOCBP), have a negative urine pregnancy test,and abstain from sexual activity or use a double barrier method (e.g. condom anddiaphragm) of birth control from Day 1 and up to 2 days after study drugadministration.

4. Willing to refrain from alcohol consumption within 24 hours of randomization

5. Are competent to provide informed consent

6. Voluntarily provide informed consent in accordance with governing InternationalReview Board (IRB) requirements and provide Health Insurance Portability andAccountability Act (HIPAA) authorization, prior to any procedures or evaluationsperformed specifically for the sole purpose of the study

7. Indicate they understand and are able, willing, and likely to fully comply withstudy procedures and restrictions

Exclusion Criteria:

1. Subjects scheduled for simultaneous bilateral or 2nd-eye cataract surgery (subjectsscheduled for a future 2nd eye cataract surgery are eligible for the study)

2. Known sensitivity to benzodiazepines or ketamine

3. Known sensitivity to -caines (including proparacaine, ester-type local anesthetics),benzalkonium chloride (BAK)

4. Intraocular pressure (IOP) > 30 mmHg in the study eye or fellow eye at screening.

5. History of iritis, or any ocular trauma with iris damage in the study eye

6. Presence of active corneal pathology other than dry eye per slit lamp and externaleye exam at screening in either eye

7. Presence of extraocular/intraocular inflammation in either eye

8. Presence of active bacterial and/or viral infection in either eye

9. History of intraocular non-laser surgery in the study eye within the 3 months priorto day of surgery, or intraocular laser surgery in the study eye within 30 daysprior to the day of surgery

10. Requiring or planning other additional ocular surgery during the cataract surgery (e.g. glaucoma surgery ([minimally invasive or traditional], limbal relaxingincisions, etc.) or performing laser-assisted CELR

11. Presence of active infection, mucositis, cold sores, canker sores, vesicles, virallesions, local irritation/inflammation, or periodontal disease of the oral cavity.In addition, evidence of piercings of the tongue or anywhere in the oral cavity,history of oral cavity piercings, history of significant dental disease, or historyof dysphagia.

12. Women who are nursing a child or plan to nurse a child during the study

13. Have a history or clinical manifestations (e.g., signs, symptoms, laboratory values,diagnostic imaging, etc.) of significant gastrointestinal, cardiovascular, hepatic,renal, hematological, endocrine, neurological, psychiatric, respiratory, or othermedical condition that in the opinion of the investigator might confound the studyresults or pose additional risk in administering the study procedures

14. Use of disallowed medications including the following:

15. Antihypertensive agent or diabetic regimen at a dose that has not been stablefor at least 30 days prior to Day 1, or which is not expected to remain stablethroughout the study

16. Central nervous system (CNS) active drugs such as benzodiazepines, tricyclicantidepressants, serotonin and norepinephrine reuptake inhibitors (SNRIs), orselective serotonin reuptake inhibitors (SSRIs) that have not been stable forat least 30 days prior to Day 1, or which is not expected to remain stablethroughout the study

17. Initiating the use of, switching to a different, or increasing the dose of asleep medication (e.g. lorazepam, zolpidem, etc) within 3 days of randomization

18. Illicit drug use or alcohol abuse based on medical history, or currently engaged inillicit drug use or alcohol abuse.

19. Alcohol abuse is defined as 5 or more drinks in one sitting or 15 or moredrinks in a week for men and 4 or more drinks in one sitting or 8 or moredrinks in a week for women. A drink is considered a 1.5 oz shot, 12 oz of beer,or 5 oz of wine.

20. However, patients with a medical history of illicit drug use or alcohol abuse ≥ 5 years prior to the time of screening and who have recovered and have beendrug/alcohol free for at least that period of time (i.e., 5 years) can beenrolled C. Patients with a medical history of medical or recreationalmarijuana (including THC and /or CBD) use ≥ 1 year prior to the time ofscreening and have been marijuana free for at least that period of time (i.e. 1year) can be enrolled

21. Creatinine clearance rate < 60 mL/min estimated using the CKD-EPI 2021cr (NKD)equation

22. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkalinephosphatase (ALP) > 2.5 times upper limit of normal (ULN), or total bilirubin > 1.5x ULN. In cases of documented Gilbert syndrome, subjects with elevated bilirubinlevels will be permitted to enroll in the study if other liver function tests arewithin the specified limits

23. Any other abnormal laboratory results or presence of any condition that theInvestigator believes would put the subject at risk or confound the interpretationof results