This article was reviewed by Ramin Khoramnia, MD

The fluocinolone acetonide implant (Iluvien; Alimera Sciences) maintained good real-world visual levels in patients with 

The open-label, observational Iluvien Registry Safety Study (IRISS)

(NCT01998412) collected real-world data on the safety and efficacy of the 0.2 µg/day of fluocinolone acetonide implant for treating chronic DME, defined as recurrent DME that was insufficiently response to available therapies.

What an intravitreal integrin antagonist may bring to DME

The DME had been present for a mean of 4.95 years. The patients were followed from the time of implantation of the device to 3 years postoperatively, according to Ramin Khoramnia, MD, of the University Eye Clinic Heidelberg, David J. Apple International Laboratory for Ocular Pathology, in Heidelberg, Germany.

A total of 295 patients (343 eyes; mean age, 66.3 years) were included in the study at 41 European sites. The mean baseline visual acuity (VA) was about 52 Early Treatment Diabetic Retinopathy Study letters. 


Most eyes (97.7%) had undergone laser or intravitreal treatment. Patients have had an insufficient response to previous therapies before being treated with the (Iluvien) implant—that is, they had been treated according to the licensed indication in Europe.

“Regarding supplemental therapies, 51.3% of Iluvien-treated eyes that had not optimally responded to previous therapy received no additional treatments during the 36 months,” Khoramnia said. “This fact is particularly interesting because previous treatments had been suboptimal in terms of outcomes.

5 ways the DRCR Retina Network is reshaping diabetic eye disease

During the 36-month study period, a mean of about 7.4 supplemental treatments were given; 11.1% of patients received a second implant after about 2.8 years following implantation, Khoramnia noted.

“The intraocular pressure [IOP] remained stable throughout the study and was in the normal range at every time point at which the patients were evaluated,” he said.

About 40% of patients had IOP elevations that were managed medically; a surgical intervention was required to lower the IOP in 3.2% of eyes.


Regarding VA outcomes, the VA required to drive (20/40) improved in 18.2% of eyes at baseline to 33.0% at 12 months and this level remained stable until the 36-month time point. 

DME strategies directed by knowledge of mechanisms



In almost three-quarters of eyes (≥71%), the VA remained stable or improved over the 36 months. In eyes in which the baseline VA exceeded 20/40, the VA did not change significantly from baseline at any visit during the 3-year follow-up.

Khoramnia concluded that for patients completing 3 years of follow-up, the real-life outcomes confirm the long-term safety and effectiveness of the implant for treating DME in a cohort of patients larger than the European Union registration trial population. 

The results from clinical practice show changes in IOP and VA similar to those in the pivotal FAME trials.

“It is important to mention that real-world studies, especially those of DME, rarely confirm the good outcomes of the pivotal trials,” he said. “The data also showed that earlier treatment of DME in patients with better vision before the onset of substantial visual impairment stabilized vision for 3 years.” 


This article is adapted from Khoramnia’s presentation at the American Academy of Ophthalmology’s virtual 2020 annual meeting. He is a researcher for Alimera Sciences and receives lecture fees from the company.


1. Chakravarthy U, Taylor SR, Koch FHJ; ILUVIEN Registry Safety Study (IRISS) Investigators Group. Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries. 

 2019;103(8):1072–1077. doi:10.1136/bjophthalmol-2018-312284

2. Campochiaro PA, Brown DM, Pearson A, et al; FAME Study Group. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. 

. 2012;119(10):2125-2132. doi:10.1016/j.ophtha.2012.04.030

Articles

Fluocinolone acetonide implant for DME benefits visual acuity.

IRISS registry study offers real-world outcomes 

ThermaMEDx has unveiled a self-heating, pre-moistened, disposable, sterile cleaning eye-pad (EverTears) for use in treating the symptoms of dry eyes and meibomian gland dysfunction (MGD).

According to the company, the patented technology combines two proven treatments - - moist, precise heat and a sterile cloth cleaning pad into one easy to use, affordable product patients can use at-home.

Professor Michel Guillon, inventor of the patented technology, noted that the commercial launch of the product is the culmination of more than 30 years of research in Ocular Surface Disease.

“We are appreciative of all the support from doctors here at ThermaMEDx as well the enthusiastic response from eye care professionals throughout the US," Guillon, a scientist, innovator and optometrist practicing in London, England, said in a statement.

The eye-pad was unveiled in late March at the Texas Optometric Association meeting in Austin, with more than 92% of physicians surveyed indicating that they would recommend the product to their dry eye and MGD patients.

"We need more effective, affordable and convenient solutions for our Dry Eye patients to use at home, because compliance is a huge issue with home care,” Marguerite McDonald, MD, who performed the world's first laser vision correction procedure after years of research, said in a statement. “I have been impressed with how EverTears has brought the proper science to market in a product that many patients will actually enjoy using."

According to the company, the product will be available without a prescription from ophthalmologists nationwide beginning in June.

ThermaMEDx has unveiled a self-heating, pre-moistened, disposable, sterile cleaning eye-pad for use in treating the symptoms of dry eyes and meibomian gland dysfunction.


Company launches product targeting dry eye, MGD


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

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

New options continue to fill sustained drug delivery pipeline


Peter J. Polack, MD, FACS, and Zora Harrison, COO at Ocala Eye in North Central Florida, share the protocols and technology their practice implemented throughout the pandemic that has enabled them to safely and efficiently treat their patients.

COVID-19: Year in the life of ophthalmology practice

Podcasts

Find out how one eye care practice has found success in adapting their services to ensure staff/patient safety throughout the pandemic. 

Adjusting ophthalmology practice to a pandemic 


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 

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

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

Cheryl Guttman Krader is a contributor to Dermatology Times, Ophthalmology Times, and Urology Times.

This article was reviewed by Albert J. Augustin, MD

A retrospective study including patients with at least 12 months of follow-up care shows that the intravitreal dexamethasone 0.7-mg implant (Ozurdex, Allergan, an AbbVie company) provides safe and durably effective treatment for 

 across the spectrum of patients who are seen by physicians in routine clinical practice.

Although the research found that treatment-naïve patients generally had greater benefit than those with a history of anti-VEGF treatment, it also showed that eyes with long-standing chronic DME responded to the intravitreal sustained-release steroid treatment. 

In addition, the analyses showed that effectiveness was not related to reinjection interval.

“Although evidence from clinical trials shows the safety and efficacy of the dexamethasone implant for treating DME, it is important to collect data from real-world settings,” said Albert J. Augustin, MD, professor and chairman of the Department of Ophthalmology, Klinikum Karlsruhe, Karlsruhe, Germany, and lead author of the study.


Augustin noted that the results of the study are consistent with prior studies and support the utility of the intravitreal dexamethasone implant as a treatment for DME in routine practice.

“However, the results are preliminary and further, larger-scale studies are warranted,” he pointed out.

The study identified 141 patients treated at 7 hospital-based medical retina centers in Germany (n = 108) and Switzerland (n = 33). 

Eligible patients had DME-related visual impairment and at least 12 months of follow-up after the first implant injection. 



For each patient, data from a single eye was analyzed—either the eye that received the most injections or one chosen by the investigator if injection number was the same for both eyes.



The baseline data showed that compared with the Swiss cohort, patients from Germany had a longer history of DME (106 vs 31 months) and included a greater percentage of anti-VEGF treatment-naïve patients (40.7% vs 3.0%). 

In addition, considering the subgroup of patients who had received anti-VEGF injections, the mean number of injections was 2-fold higher in the German cohort compared with the Swiss patients (63 vs 31). 

At baseline, the mean best corrected visual acuity (BCVA) for the study eyes was 61.6 letters and mean central retinal thickness (CRT) was 413.3 μm.

According to investigators, changes from baseline to 7 to 12 weeks post injection for both BCVA and CRT were analyzed as efficacy end points.

Post hoc analysis: Protocol V provides more practical DME guidance for clinicians

Across the entire cohort, the mean number of reinjections was 3 (range, 1-11) and they were given at a mean interval of 5.7 months (median, 4.6 months).

BCVA was relatively stable after each reinjection with a mean change from baseline BCVA of +3.4, +3.7, +3.2, and –1.4 letters at 7 to 12 weeks after the first injection and reinjections 1, 2, and 3, respectively.


Relatively greater benefit was seen in the analyses of CRT with changes from baseline of –88.3, –81.6, –102.4, and –124.1 μm at 7 to 12 weeks after the first injection and reinjections 1, 2, and 3, respectively.

Augustin explained that it is well known that CRT does not necessarily correspond with visual acuity.

“In some patients, an increase in visual acuity follows the CRT improvement,” Augustin pointed out. “However, in other patients, it is necessary to evaluate the retinal structure in more detail to understand the phenomenon.”



Identifying gaps in anti-VEGF treatment among minorities with DME

Augustin noted that this is why investigators have to look at other optical coherence tomography (OCT) results, such as retinal structure, external limiting membrane, ellipsoid zone, etc.

“EURETINA [the European Society of Retina Specialists] has published a guideline focusing on such OCT results that helps us to better predict the result of intravitreal treatments in patients with DME,” he added.


Patients receiving the intravitreal dexamethasone implant as their first treatment for DME had worse BCVA at baseline than their previously treated counterparts (mean, 57.8 vs. 63.4 letters) and “more” DME (mean CRT, 439.1 vs 400.6 μm).

Compared with the patients who had a history of anti-VEGF treatment, the treatment-naïve patients had greater functional improvement, but less change in CRT.

Augusting noted that the mean change in BCVA from baseline after the first injection in the treatment-naïve and previously treated patients was +4.7 vs +3.0 letters, respectively, and was +4.2 vs +3.5 letters, respectively, after the first reinjection. 

Mean CRT change from baseline in the treatment-naïve and previously treated patients was -74.3 vs -63.8 μm, respectively, after the first injection and -63.8 vs -85.8 μm, respectively.

The Spearman correlation coefficient showed there was no statistically significant correlation between reinjection interval and either change from baseline in BCVA or CRT for the overall population or in analyses performed for each country individually, Augustin reported.


“Although there was not a significant correlation between reinjection interval and change from BCVA, the small loss in BCVA that was seen after the third reinjection may be due to the reinjection interval,” Augustin said.

The DRCR Retina Network's top 5 greatest hits

Moreover, he noted that treatment with the dexamethasone implant had a favorable safety profile in patients. 

Only 18% of patients experienced at least 1 adverse event, with ocular hypertension being the most common. There was no increase in number of adverse events with increasing number of injections.

This article is based on Augustin’s presentation at the EURETINA 2020 virtual meeting. Augustin has received research support and consulting/advisory fees from Allergan and other companies that market products used for the treatment of DME.

Eyes with chronic disease responded to steroid treatment.

DME study documents robust efficacy of intravitreal dexamethasone implant 

This article was reviewed by Antonio M. Fea, MD

Findings of a cost-utility analysis confirm that from the perspective of the Italian national health system, a dual procedure combining phacoemulsification with implantation of two trabecular microbypass stents (iStent inject, Glaukos) is a cost-effective option for the treatment of mild to moderate open-angle 

A menu of glaucoma treatments includes options to fit all scenarios

“Many patients with glaucoma develop cataracts and the iStent inject has been shown to lower IOP and reduce the usage of ocular hypotensive medications in randomized studies comparing concurrent iStent inject and cataract surgery with cataract surgery alone,” said Fea, who is a professor in the Department of Surgical Sciences and the head of the Glaucoma Unit at the University of Turin in Italy. “Our study demonstrates the cost-effectiveness of the combined surgery vs cataract surgery alone in a base case model with confirmation of its robustness through sensitivity analyses.”

The analysis simulated outcomes and costs over a lifetime horizon using a Markov chain. 

The model is built on mild, moderate, advanced, and severe open-angle glaucoma being 4 mutually exclusive states through which patients can progress irreversibly at 1-month cycles.

Exploring the evolution of interventional glaucoma

“When patients experience disease progression despite active treatment, they are assumed to undergo subsequent treatment, which in this case is trabeculectomy,” Fea explained.

The model was populated with efficacy data extracted from the iStent inject clinical trials and published literature. 

Quality adjusted life years (QALYs) were estimated as the sum of life years spent in each health state weighted by the associated utilities. The utilities associated with the different health states were extracted from studies published in the peer-reviewed literature.

“Because of differences in costs throughout Italy, we decided to consider only direct health care costs, including the costs of the primary and subsequent procedures, medications, disease monitoring, and adverse events,” Fea pointed out.

MIGS, other options offer hope for angle-closure patients

The base case results showed that as measured by QALY survival, the combined glaucoma-cataract surgery procedure was more effective than cataract surgery alone (11.38 QALYs vs 11.28 QALYs, respectively). 

Although the use of the iStent inject led to a slight increase in total costs, the combined surgery was cost-effective compared with cataract surgery alone, with an incremental cost-effectiveness ratio (ICER), which represents the ratio of the difference in cost and the difference in QALYs, of €12,717 per QALY gained.

Additional analyses conducted to assess the robustness and reliability of the base case results included one-way deterministic and probabilistic sensitivity analyses. 

The one-way deterministic sensitivity analysis showed the ICER variability was modest, ranging from approximately €8700 to €24,000 per QALYs gained.

Optimizing and modifying newer glaucoma surgeries

The probability sensitivity analyses showed the probability of the combined surgery being cost-effective was about 98% at a willingness to pay threshold of €50,000 per QALY and was still 91% at the commonly accepted willingness to pay threshold of €30,000 per QALY, Fea noted. 


This article is based on a paper presented by Fea at the ESCRS 2020 virtual meeting. Fea is a consultant to EyeD, Glaukos, iSTAR Medical, Ivantis, and ELT Sight and receives research support from Allergan.

Investigators find treatment is an option for treating open-angle glaucoma.

Study examines pairing phacoemulsification, implantation of microbypass stents

This article was reviewed by A. John Kanellopoulos, MD

The initial results of customized myopic LASIK using automated ray tracing optimization offer improved and predictable results. 

The procedure is driven by artificial intelligence (AI) and represents a clear step forward in LASIK technology.

The roots of the technology are based in topography-guided treatments introduced in Europe in the early 2000s, and the treatment approach grew into the Athens Protocol that combines topography-guided and partial transepithelial PRK and corneal crosslinking.

IOLs offer great vision, low risk profile for myopia

“The topography-guided treated were used to treat sick or problematic eyes, with enlargement of optical zone and treating irregularities such as those seen in keratoconic eyes,” noted A. John Kanellopoulos, MD, from the LaserVision Clinical and Research Eye Institute in Athens, Greece, and New York University Medical School.

The advances in the technology are demonstrated by the surgeon’s ability to treat, for example, a herpetic scar. 

The topography-guided procedure could return the cornea to a normal state; in contrast, before the availability of the technology, a corneal transplant might be considered in a patient who was contact lens intolerant. 

One lesson learned because of the new ability to treat irregular corneas is that the technology—that is, topography-modified refraction (TMR)—also can be used to treat normal eyes, he explained.

"Use of TMR in routine myopic eyes not only achieves emmetropia but also pushes the envelope to achieve significant gains in lines of vision postoperatively,” Kanellopoulos said.

Novel technique provides another option for normal and irregular corneas.

Study examines pairing phacoemulsification, implantation of microbypass stents

AI enhances customized myopic LASIK with ray tracing optimization

Johnson & Johnson earns FDA clearance, CE mark for next-gen phaco machine