
Numerous drug delivery systems have been developed for 

, and many have made their way into phase 2 and phase 3 trials.

The approaches developed in these local sustained-delivery systems include intravitreal injections in which a depot forms and emits drugs over time, intraocular sustained delivery implants, and gene therapy, according to Glenn J. Jaffe, MD, an ophthalmologist and retina specialist at Duke Eye Center in Durham, North Carolina. He also is a professor of ophthalmology at Duke University in Durham.


KSI-301 (Kodiak Sciences), an intravitreal anti–vascular endothelial growth factor biopolymer conjugate that releases the drug from a depot, is being tested in the DAZZLE study (NCT04049266) to treat neovascular AMD by providing individualized dosing from 3 to 5 months. 

The platform was compared with aflibercept (Eylea, Regeneron Pharmaceuticals), administered intravitreal every 8 weeks. The study recently completed enrollment of the phase 2b/3 pivotal trial for wet AMD. The platform also will be tested in a phase 2 study to treat DME.

Sunitinib (Graybug Vision) is another depot that inhibits tyrosine kinase and dual leucine zipper kinase. 

This pegylated poly(lactic-co-glycolic acid) depot has been evaluated in the phase 2b ALTISSIMO trial (NCT03953079) for treating AMD. 

Two dosing regimens (1 or 2 mg of GB-102) that are administered every 6 months were originally compared with aflibercept. The drug was reformulated to 1 mg.

PDS with ranibizumab signals paradigm shift in treatment of nAMD

The Port Delivery System (PDS), an intraocular sustained delivery implant containing ranibizumab (Lucentis, Genentech), is an implanted refillable reservoir currently being evaluated in the phase 3 Archway and Portal studies (NCT03677934 and NCT03683251) for neovascular AMD. 

It is also being evaluated in the phase 3 Pagoda trial for DME. The results of Archway showed that the PDS met its primary end point of equivalency to ranibizumab. 

ADVM-022 (Adverum Biotechnologies) is a gene therapy with an engineered adeno-associated vector (AAV.7m8). The therapy includes an aflibercept coding sequence.

“The FDA has given a fast track designation to this agent that is designed to be a 1-injection treatment,” Jaffe said.

ADVM-022 is presently being evaluated in the INFINITY phase 2 trial (NCT04418427) for treating DME, and the early results have been favorable, he reported. Another phase 2 trial is planned for AMD.

ADVM-022 offers sustained anatomic improvements in wet AMD


Sirolimus (DE-109, Santen Pharmaceutical Co), a macrolide antibiotic, is administered as an intravitreal injection for treating noninfectious uveitis of the posterior segment. Injecting the drug forms a depot that releases the agent over about a 60-day period. Sirolimus blocks T- and B-cell activation and inhibits antigen-presenting cells.

According to findings from the phase 3 SAKURA-1 study (NCT03014622), sirolimus showed positive results for treating noninfectious posterior segment uveitis. 

However, the study end point was not met in SAKURA-2 (NCT03014635). When the studies were combined for FDA review, the administration required a third trial, and the LUMINA study (NCT03711929) is underway.

Intravitreal sustained drug delivery systems also have been developed to treat uveitis. 

HP-B-CD: AMD therapy with cholesterol-lowering capabilities

The fluocinolone acetonide implant (FAi) long-acting delivery system, which is intended to treat noninfectious intermediate, posterior, and panuveitis, is injectable, according to Jaffe, whose laboratory is spearheading this research. 

This 3-mm-long polyamide tube has a core of fluocinolone acetonide. The system is injected using a modified 25-gauge injector, and the drug is released over a 3-year period.

Jaffe explained that injecting the implant is similar to inserting small-gauge cannulas for vitrectomies. To do so, he marks the eye 4 mm posterior to the limbus, retracts the conjunctiva, and injects at a slight angle to engage the conjunctiva.

However, the injection is actually administered perpendicular to the globe and straight into the vitreous cavity.

The FAi delivery system was evaluated at Duke University in an individual investigator study.

Tool offers ultra-rapid cooling for intravitreal injections

“The very positive data led to the phase 3 study

to test the efficacy and safety of 1 FAi to treat intermediate, posterior, and panuveitis,” Jaffe said. “The results showed a greatly prolonged time to recurrence, that is, about 1000 days in the implanted group compared to 95 days for the sham group. This represented a 10-fold reduction in the time to recurrence in the implanted group.”

The data also showed that the mean intraocular pressures were similar between the 2 groups. The system (Yutiq, EyePoint Pharmaceuticals) was approved in October 2018 to treat the 3 forms of uveitis.

Suprachoroidal delivery of drugs is another possibility. CLS-TA (Clearside Biomedical), a formulation of triamcinolone acetonide, is intended to treat uveitic macular edema and was evaluated in the phase 3 PEACHTREE trial (NCT02595398). 

The formulation met the primary end point, with participants gaining 15 or more lines of vision compared with the control (47% vs 15.6%, respectively). 

Easing patient comfort, pain perception of intravitreal injections

The mean change in the best-corrected visual acuity favored the implant and was 11 letters greater at the 24-week evaluation. The improved vision was accompanied by a significant decrease of about 135 µm in the central subfield thickness compared with the control, according to Jaffe.

Gene therapies are also being developed to address uveitis. Eyevensys has designed a novel nonviral gene therapy with an electroporation approach, an antitumor necrosis factor plasmid, which is delivered locally to the ciliary body. Investigators are evaluating the technology in a phase 2 trial.


“There is a robust pipeline of neovascular AMD, DME, and uveitis sustained-delivery drugs and novel drugs and delivery systems,” Jaffe concluded. “Clinical trial readouts from several new studies are expected within the next few months. The future appears bright.”


Dr Jaffe has been a consultant to Novartis, Regeneron Pharmaceuticals, EyePoint Pharmaceuticals, Adverum Biotechnologies, and Eyevensys.


1. Jaffe GJ, Foster CS, Pavesio CE, Paggiarino DA, Riedel GE. Effect of an injectable fluocinolone acetonide insert on recurrence rates in chronic noninfectious uveitis affecting the posterior segment: twelve-month results. 

. 2019;126(4):601-610. doi:10.1016/j.ophtha/2018.10.033

Articles

Injections, implants continue to create further positive outcomes for patients.

New options continue to fill sustained drug delivery pipeline


This article was reviewed by Francis S. Mah, MD



Dexamethasone ophthalmic insert 0.4% (Dextenza, Ocular Therapeutix, Inc) has demonstrated fast and effective action for treating inflammation and pain after 

. 

Patient adherence with drop regimens has always been problematic and may be more so in an elderly population and perhaps compromise patient outcomes as the result of subtherapeutic treatment.

This intracanalicular implant is a hands-free alternative to traditional drops and provides tapered therapy for up to 30 days after insertion, according to Francis S. Mah, MD, director of cornea and external disease and coordinator of refractive surgery at Scripps Clinic in La Jolla, California.

Studies explore pharmacological approaches to cataract prophylaxis, treatment

Multicenter phase 3 studies of the efficacy of the insert were designed to provide a cumulative measure of the drug effect and the time at which postoperative inflammation and pain resolved after the implant’s insertion. 

The pooled post-hoc analysis included 926 patients who had undergone cataract surgery and intracanalicular insertion on day 1. 

The patients were randomized to 1 of 3 phase 3 trials; 541 patients received active treatment and 385 received placebo. No patients in the active treatment groups received topical nonsteroidal anti-inflammatory drugs.

The primary end point was the cumulative drug effect based on anterior chamber cell and flare scores and pain scores; the other end point was the time to resolution of inflammation and pain based on clinically relevant anterior chamber cell scores and pain scores, Mah recounted.

Challenges to topical drop adherence after cataract surgery


Mah noted that the mean anterior chamber cell, flare, and pain scores all differed significantly in favor of the implant as soon as 4 days postoperatively for inflammation and 2 days postoperatively for pain.

“The cumulative drug effect of the treatment as evidenced by the area under the curve (AUC) outcomes compared with placebo suggested the consistency of the drug effect benefits over 30 days,” he said.

 ≤ 0.001 for all comparisons) differences between the active treatment groups and placebo in anterior chamber cells, flare, and pain.

Drug delivery vs drops: Controlling postop pain, inflammation in cataract surgery patients


The insert resulted in earlier resolution of inflammation that was about twice as fast as placebo, ie, day 7 vs day 14). 

Significantly (

 < 0.05 by the log-rank test) faster pain resolution also was seen with the insert on day 4 compared with day 14 in the placebo group in the 75th percentile population, he said.


The key takeaways from the study were that the AUC demonstrated the consistency of the drug effect benefits over 30 days in the 3 clinical trials that included a total of 926 patients. 

Study outlines use of injectable intraocular steroid over drops



The pooled post hoc analysis showed that the insert provided faster time to clinically relevant resolution of inflammation after cataract surgery compared with placebo. 

The 75th percentile population had faster pain resolution with the insert compared with placebo.

“These data support the totality of available evidence for [the insert’s] rapid and consistent efficacy in the treatment of postcataract inflammation and pain. Further studies investigating [the insert’s] comparison with other steroid eye drops are currently being conducted,” Mah concluded. 


Mah is a consultant for Ocular Therapeutix, Inc, and was an investigator in the clinical trial. Ocular Therapeutix, Inc, sponsored the study under discussion.

An alternative to drops, the option provides consistent therapeutic levels.

Intracanalicular dexamethasone insert offers hands-free therapy 

Comparable conscious sedation methods address individual patient needs

The amount of anesthesia used to keep a patient relaxed and comfortable throughout cataract surgery is tailored to each patient based on many factors, including age, medical history, and anxiety levels. 

The method by which sedation is applied can be similarly tailored. Surgical anesthesia is not a one size fits all endeavor: 

Some cataract patients feel comfortable following the traditional route where sedation includes intravenous (IV) versed or fentanyl or both, while others prefer a troche -- a lozenge that enables them to avoid both IV needles and opioids. 

Patients who have extensive medical histories such as those who have blood pressure problems, breathing problems that represent potential airway issues, and significant cardiac histories are better suited to IV sedation.



If patients prefer a less invasive sedation method or have ‘challenging’ veins, the troche approach can be an excellent option, for appropriate candidates. 

Today, many patients appreciate the option of opioid-free sedation. 

This is true for patients who have a history of opioid dependence, as well as others who simply prefer to avoid any potential problems that opioids could present. 

As long as they are appropriate candidates for the troche, their preference can be taken into account.

We have made the option of troche sedation available to appropriate cataract patients for several years. In particular, we use the sublingual MKO MELT (ImprimisRx), a compounded formula comprised of 3 mg midazolam, 25 mg ketamine, and 2 mg ondansetron. 

Post-operative surveys of patients consistently revealed that the troche patients were relaxed and comfortable throughout the process, and that they appreciated the absence of an IV needle stick. 

This positive feedback supported our ongoing use of MKO, but we wanted something more than anecdotal evidence and positive patient feedback to validate this option as its usecontinued to grow in the practice.



My colleagues and I initiated a study comparing sublingual troche with traditional IV sedation, for maintaining comfort in patients undergoing cataract surgery.

The results showed comparable experiences for both groups with equivalency in patient comfort among both women and men. We concluded that troche sedation provides an effective alternative anesthesia technique for cataract surgery. 

Our findings were not surprising, as they reflected what we had seen for several years in practice.

We conducted the study at a surgery center using an after-only nonequivalent control group design. The cohort of 107 patients ranged from 55 to 85 years of age; 54 patients received IV sedation, and 53 received troche sedation. 

Good nutrition optimizes ocular surface in premium cataract patients

Four patients receiving IV sedation reported nausea during and after the procedure or pain during the procedure, whereas 3 patients receiving troche sedation reported dizziness after the procedure, and pain during the procedure. 

Although the troche group spent less time in recovery than the IV group the difference was not significant.

Most patients received 2 MKO troches; of these 36 patients, 28 were 70 years of age or younger. The dosing of the troche sedation was determined by the age of the patients, medical history, and medications the patients were taking. 

Five patients were dosed 1.5 MKO troches; and 12 were dosed 1 MKO troche. 

Both the IV and troche groups stayed in recovery an average of 6 minutes, with the troche group experiencing only slightly less time than those in the IV group: 6.24 minutes vs 6.48 minutes. 

The total time from administration of troche to incision for the patients receiving troche sedation varied from 20 to 73 minutes, with a mean of 41 minutes. 

Changing patient conversations around cataract surgery

Timing the medication for a surgical incision is challenging because delays in transportation to the operating room and initiation of the procedure can risk decreasing the medication efficacy. 

Sedation techniques were equivalent and effective for those experiencing first or second cataract surgeries. 

During the study, almost 60% of the patients had their first cataract surgery. Only 1 participant, who received IV sedation, reported pain during the first cataract surgery. 

For second cataract surgeries, equal numbers of patients from the troche group and the IV sedation groups reported pain. Consistent with other research, more patients reported perceived pain with second cataract surgeries.


The troche method has other advantages in addition to needle and opioid avoidance.

For instance, there is potential for decreased preoperative preparation time, as well as postoperative discharge time for troche sedation. This equates to a potential cost savings. 

Drop-free prophylaxis regimen before cataract surgery lowers treatment burden with caveats

At the time of our study, the cost of two troches was $30. The cost of IV sedation at the surgery center where the study took place, including a single IV insertion attempt and sedation with midazolam and fentanyl, totaled approximately $13. 

However, the cost for IV sedation did not take into account the time for a trained individual to initiate catheter placement or the additional cost of multiple IV attempts.

The main takeaway is that MKO Melt is a comparable alternative to IV sedation and that anesthesia should be tailored to each patient.

Intravenous catheter placement preoperatively can be difficult and time-consuming, not to mention uncomfortable for the patient. 

However, it’s important to remember that the sublingual troche is not appropriate for everyone and should be considered an alternative not a replacement




Smith is a faculty member, Nurse Anesthesia Program, College of Applied Studies, Florida State University, Panama City, Florida, and a practicing CRNA, Jackson Anesthesia Associates, Marianna, Florida.  

The author has no financial interest to report.

1. Smith JC, Hamilton BK, Stacey AV. Patient Comfort During Cataract Surgery: A Comparison of Troche and Intravenous Sedation.

2020; 88:429-435.
2. Akkaya S, Ozkurt YB, Aksoy S, et al. Differences in pain experience and cooperation between consecutive surgeries in patients undergoing phacoemulsification. 

The method by which sedation is applied to keep patients relaxed and comfortable throughout cataract surgery can be tailored similar to that of anesthesia — surgical anesthesia is not a one size fits all endeavor. 

Study finds sublingual troche, IV sedation are equivalent for cataract surgery

This article was reviewed by Sung Min Kim, MD



Study results from a comparison of the LASIK, PRK, and SMILE procedures showed that the least amount of myopic regression occurred with SMILE, regardless of the degree of myopia. 

Sung Min Kim, MD, credited this result to proper adjustment of the surgical nomogram, which resulted in an exceptionally low enhancement rate.

SMILE is a single-step, flapless, femtosecond laser surgery. This study result showed SMILE causes less dry eye and lower induction of aberrations postoperatively compared with LASIK and PRK. 

Tips to chart a course for safe, effective refractive surgery

Kim pointed out that in addition, the long-term visual outcomes were also comparable among the 3 surgeries.

Enhancement rates after SMILE are low, but the need remains; In recent studies, enhancement percentages ranged from 2.2% to 2.9% in association with older patient age and higher degrees of myopia. 

However, Kim reported that his enhancement rates were considerably lower after 10 years’ experience with SMILE.


The investigators, Kim and Hyung-Jin Koo, MD, undertook a retrospective study to assess the enhancement and regression rates after LASIK, PRK, and SMILE and assess how each performed with varying degrees of myopia. 

In addition, the investigators wanted to determine the risk factors for enhancement procedures. Both physicians are from the Nunemiso Eye Clinic in Seoul, South Korea.

Iris-fixated IOLs are a boon for treating high myopia

The investigators reviewed all refractive cases performed at the Nunemiso Eye Clinic from January 2010 to November 2019 to treat myopia or myopic astigmatism. 

They also measured uncorrected and corrected distance visual acuity, spherical equivalent (SEQ), and central corneal thickness (CCT) both preoperatively and postoperatively.

The preoperative data included intraocular pressure, anterior chamber depth, pupillary size, and high-order aberrations. 

The parameters collected intraoperatively were the optical zone, lenticular diameter and thickness, ablation depth, residual stromal bed (RSB), and the percentage of tissue altered (PTA).


In this study, the investigators defined myopic regression as a residual myopic error of –1.0 D or more. 

Celebrating a pivotal moment in laser-vision correction history

Patients were candidates for a second surgery when the residual myopic error was –1.0 D or more, the uncorrected vision was less than 20/30, or patient satisfaction was low despite a visual acuity of 20/25.

The patients were divided into 3 groups based on the preoperative SEQ. Mild myopia, defined as a SEQ of –3.0 D or less; moderate myopia defined as –3.0 D < SEQ < –6.0 D or less; and high myopia, defined as –6.0 D < SEQ < –9.0 D or less, Kim explained.

The VisuMax femtosecond laser (Carl Zeiss Meditec) was used for the SMILE and Femto-LASIK procedures, excimer lasers (MEL 80, Carl Zeiss Meditec) (Allegretto Wave EYE-Q, Alcon) for PRK and LASIK procedures, and the One Use-Plus microkeratome (Moria) excimer laser was used to make the LASIK flaps. 


A total of 63,416 cases comprised the SMILE (79.4%), PRK (14.9%), and LASIK (5.7%) cases.

The regression rates of all subjects among the SMILE, PRK, and LASIK cases were 1.3%, 3.0%, and 3.8%, respectively, Kim said.

Improving LASIK outcomes with biomechanical analysis

When the cases were divided by the degree of myopia, the respective regression percentages in the mild myopia group (12,369 cases) were 0.3%, 1.5%, and 1.9%; in the moderate myopia group (35,410 cases), 0.6%, 2.5%, and 3.5%; and in the high myopia group (15,637 cases), 3.8%, 4.9%, and 6.7%.

“SMILE was associated with the lowest myopic regression rate postoperatively among all the myopic ranges,” Kim said. “The rate of myopic regression increased significantly to 3.8% in the high myopia group even after the SMILE procedure was performed.”


The overall reoperation rate was a focus for the investigators. Ultimately, it is a serious impact for patients who would then have to endure a second procedure if the first result is not up to the expectations.

According to Kim, the overall reoperation rates in the SMILE, PRK, and LASIK patients, respectively, were 0.3%, 1.1%, and 1.2%. The average time to an enhancement was 774.5 days. 

The factors that were identified as significantly associated with enhancement surgery were older age, higher preoperative SEQ, thinner preoperative CCT, small optical zone, a large amount of ablation, thin postoperative RSB, and high PTA.

Recycling lenticules from SMILE offers benefits

When 50,336 SMILE cases were reviewed separately, older age, SEQ, smaller lenticule, thicker lenticule, thin postoperative RSB, and higher PTA were significant factors associated with an enhancement.


Kim and colleagues began performing the SMILE procedure in 2012, and the overall enhancement rate for SMILE performed over 8 years was 0.34%.

Although only one-third of the SMILE procedures were performed during the first 4 years, more than half of the enhancements were done during that time.

“The need for enhancements in most cases resulted from undercorrection caused by the imperfect nomogram,” Kim said.

From 2017 onward, despite a substantial increase in SMILE procedures performed, the enhancement rate dropped.

“At that time, the SMILE nomogram was set, and SMILE Xtra or Implantable Collamer Lens [Visian ICL] implantation has been performed since 2016 for patients with extremely high myopia,” said Kim.

IOLs offer great vision, low risk profile for myopia


Adjustment of the nomogram for SMILE resulted in a very low enhancement rate even during long-term observation. 

The possible risk factors for an enhancement procedure include high preoperative myopia, small lenticular diameter, thick lenticule, thin RSB, and a high PTA.


Kim concluded that the numbers of regression and enhancement cases could vary depending on the study setting, and the retrospective design of this study may be considered a limitation.

“However, considering the very long-term large number of analyses, our review is very meaningful for comparing the outcomes of the 3 refractive operations and determining the long-term safety,” Kim explained. “SMILE was shown to be a safe refractive surgery for patients with myopia that is associated with low rates of regression or enhancement.” 


Kim has no financial interest in this subject matter.

Refractive surgery for treating myopia is linked to low rates of regression, enhancement.

SMILE offers low enhancement rate after nomogram adjustment

With steady incremental improvements throughout its evolution, cataract surgery has become one of the most frequently performed and successful surgical procedures worldwide.

Despite this well-deserved track record, there remains a segment of the patient population that has reservations, and sometimes fears, about this procedure. 

Having performed thousands of cataract surgeries, I find that patients are sometimes more stressed about sedation than about cataract removal and IOL implantation.


Intravenous (IV) administration of anesthesia has traditionally been the method by which patients are sedated prior to 

Various IV agents, including midazolam, are used for this purpose. Midazolam, which is a benzodiazepine, has properties similar to an anxiolytic, a muscle relaxant, and an amnestic. These properties make it an excellent option for many but not all patients. 

For instance, anxious patients who are administered IV benzodiazepines at cataract surgery might require higher doses during the procedure, which can result in oversedation.

This type of response can reduce the patient’s ability to follow simple commands and can affect the surgical outcome.

In addition, patients who receive too much sedation might nod off and awaken startled, which can compromise the surgical result.

It is not uncommon for cataract patients to be nervous about IV administration. 



Some patients are generally anxious, others have needle phobia, and there are those whose anatomy makes the needle stick challenging. 

It may take more than 1 needle stick, for instance, if the patient has veins that are small or difficult to access, if patients are dehydrated, or if they have had multiple medical procedures. 

Attempting sedation via the traditional IV method can be frustrating and painful for these patients and can slow down staff and patient flow.


Patients often believe that IV sedation is the only option. Because of this, some delay cataract surgery, which can affect their quality of life as well as their safety. 

For all these reasons, the movement to providing non-IV sedation is something I have been interested in for some time. 

We began offering MKO Melt (ImprimisRx) sedation in appropriate cataract surgery cases several years ago. 

This method gives these patients the option of having surgery without the preoperative pain or anxiety related to IV catheter placement, while maintaining patient comfort. 

The MKO Melt troche provides 3 mg midazolam, 25 mg ketamine, and 2 mg ondansetron, and delivers the medication via sublingual troche over a 2-minute release period.

The effects of conscious sedation are evident after 2 to 3 minutes, peak at about 15 minutes, and provide adequate sedation for up to 1 hour. 

The combination of ketamine and midazolam offers a level of sedation that is efficient and effective for patient sedation and comfort. Ondansetron adds an antiemetic to the compound.

The troche has several advantages, including the following:

> It is easier for patients, and most of our patients prefer it.

> It is quicker for the nurse anesthetist to administer.

> It lasts more than long enough to keep the patient comfortable before, during, and after a typical cataract procedure, as well as during lengthier cases such as those that include implantation of a MIGS device.


Our MKO-to-IV sedation ratio varies from as low as 50/50 to as high as 70% MKO/30% IV on a given surgery day depending on the patients scheduled. 

We make the initial decision regarding which type of anesthesia will best suit each patient at the consultation. We base this on their demeanor and medical history, and revisit and confirm or revise that decision on the day of surgery.

Reducing burden on veterans undergoing cataract surgery

We start under the assumption that every patient will be a troche candidate. Once they have been evaluated, we determine whether they would be better suited to IV sedation. 

For instance, if the patient is overly anxious or tells us that they have severe claustrophobia, we will opt for IV so that we will have the option of administering additional medication during the procedure if necessary. 

There have been times in which the patient needed more sedation than the troche provided, for example if the case were prolonged. On those infrequent occasions it was simple to start an IV.

In IV sedation and MKO, the patient is aroused enough to communicate, which is necessary especially in cases where we are implanting an advanced technology IOL.

In these cases, the patient must fixate on the intraoperative aberrometry lights. This scenario represents another area where the MKO sedation method is beneficial because I have found that ketamine reduces photophobia and makes it easier for patients to focus on the lights and steady the eye.

Perioperative medications can eliminate postoperative drops after cataract surgery

Positive patient response and speedier patient throughput are just 2 anecdotal metrics that validate our use of the MKO Melt. 

This practice is further supported by a recent clinical study that found that troche sedation is an effective and equivalent alternative to IV sedation in cataract surgery.

Jason Smith, CRNA, the lead author of the study, is affiliated with our practice and over the past several years has worked on seamlessly integrating sublingual sedation into our anesthesia armamentarium. 

Now, his study provides evidence that patients were equally satisfied with the comfort level they experienced with MKO and IV sedation, and that is also what we find when we review our patient satisfaction surveys.

These surveys typically reveal that patients experiencing MKO were very relaxed and comfortable, and that if they had their second eye done at our practice under MKO after having their initial surgery done at a different practice under IV sedation, they preferred forgoing the needle stick. 

Patients who had their initial eye done under IV sedation in our practice and their second eye under MKO also reported preferring the troche.

Although patient comfort during cataract surgery is crucial, safety is paramount. 

When investigators compared the effects of the MKO Melt with the effects of IV sedation on patients’ vital signs, they observed clinically and statistically significant improvements in preoperative and postoperative systolic blood pressure and postoperative heart rate in patients who received the MKO Melt. 

They concluded that the MKO Melt was safe, effective, well tolerated, and a viable alternative to IV sedation.


Another important benefit that we have found with troche sedation is that it provides a cost savings. It eliminates the need for IV tubing and IV solutions, and reduces personnel costs associated with IV insertion and removal. 

We are under continual pressure from Medicare and private payers to cut costs, and this sedation method makes a positive contribution toward that objective.

Investigators focus on preventing postcataract surgery endophthalmitis

Over the years we have striven to make cataract surgery a safer, simpler, and overall better experience for patients. 

This has become even more of an imperative as refractive cataract surgery aims to satisfy the demands of younger, more active patients. 

The MKO Melt represents a giant step forward in this evolution by providing patients with a relaxing and comfortable surgical experience, while eliminating the pain and angst associated with IV needles. 


Fisher is medical director and a founding partner of the Eye Center of North Florida, Panama City. He reports having been a consultant for ImprimisRx in the past.


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2. Habib NE, Mandour NM, Balmer HGR. Effect of midazolam on anxiety level and pain perception in cataract surgery with topical anesthesia. 

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3. Chandradeva K, Nangalia V, Hugkulstone CE. Role of the anaesthetist during cataract surgery under local anaesthesia in the UK: a national survey.

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4. Salmon JF, Mets B, James MF, Murray AD. Intravenous sedation for ocular surgery under local anaesthesia. 

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5. Zehetmayer M, Radax U, Skorpik C, et al. Topical versus peribulbar anesthesia in clear corneal cataract surgery. 

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6. Harman DM. Combined sedation and topical anesthesia for cataract surgery. 

. 2000;26(1):109-113. doi:10.1016/s0886-3350(99)00330-2

7. Chen M, Hill GM, Patrianakos TD, Ku ES, Chen ML. Oral diazepam versus intravenous midazolam for conscious sedation during cataract surgery performed using topical anesthesia. 

Sublingual troche sedation represents attractive anesthesia option for specific subset of patients with cataracts.

Ophthalmology Times: March 15, 2021

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Comparable conscious sedation methods address individual patient needs

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