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 This transcript has been lightly edited for clarity.

 Hi, this is Sean O'Neil, Chief Commercial Officer of ViaLase. Excited to be at the Eyecelerator meeting at AAO and provide an update on ViaLase milestones.

ViaLase is a medical device company, it's venture backed, out of Southern California. We are focused on disrupting the current conventional glaucoma treatment paradigm with the introduction of a non-invasive, image-guided femtosecond laser to address primary open angle glaucoma.

The leadership team has a vast experience in femtosecond lasers, designing, manufacturing, commercializing, the first femtosecond laser for both refractive as well as cataract and now looking to take that knowledge and leverage it within the glaucoma marketplace.

I'm excited to announce that the founder and CEO Dr. Tibor Juhasz was recently awarded the 2022 Golden Goose Award in recognition of his and his fellow researchers, finding that femtosecond lasers can make corneal incisions with high precision without damaging adjacent tissues, which revolutionized the LASIK marketplace. And we look forward to ViaLase taking that experience and recreating it and that success for glaucoma patients.

As we know with glaucoma, glaucoma treatment paradigm is typically driven by a trade-off thought process. If you want more efficacy, you typically have to give up safety. We're designing our technology to bring those into balance. And the technology is designed to create a femtosecond laser, image-guided, high-precision trabeculotomy, what we're calling the FLigHT treatment.

The FLigHT treatment again is is to include OCT-driven femtosecond laser delivery for safety and efficacy but also with an intuitive learning curve, so that is accessible to all surgeons, glaucoma specialist and cataract surgeons alike. And we're we're also working on a business model so that there is value for all stakeholders.

We're excited to provide here, at AAO Eyecelerator, a case series of data to assess safety and efficacy of an 18 patient case series non-washed-out, so real-world out to 24 months. 24 months is important in glaucoma because you want that long-term data to assess both safety as well as durability of treatment.

Of the patients in the cohort out to 24 months, they demonstrated a 31% IOP reduction and also excited to say that 100% of them achieved the 20% or greater IOP reduction, all with a very safe profile.

This data is very encouraging and we look forward to demonstrating our results in a multicenter, randomized controlled trial that is currently ongoing. Finally we are in the process of getting CE mark and we're also preparing for our submission to the FDA for 510K clearance and look forward to keeping you updated on those milestones as we prepare for commercialization.

Videos

Shawn O'Neil of ViaLase shares updates on the company's femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT) treatment.

Disrupting the glaucoma treatment paradigm with novel femtosecond laser from ViaLase

This transcript has been lightly edited for clarity.

My name is Adam Szaronos. I'm the CEO at Trukera Medical. We're so excited to be here this year in Chicago at the American Academy of Ophthalmology for a number of reasons. At Trukera Medical, we've recently rebranded our organization historically founded as TearLab, a one-product company focused on in vitro diagnostics to help advance corneal health and decision making.

After nearly 25 million tests globally, today, we're now launching our second generation system. And with that opportunity, we're now also in a position to start looking across the spectrum of corneal health needs. And with an expanded vision to be the world's leading cornea health company for providers and patients, we felt it was appropriate to make sure we had a company identity that better reflected that growing portfolio in vision.

The second reason we're excited to be here is the launch of that product itself. We've learned a lot over those 25 million tests, in particular the barriers it takes to helping to get good diagnostic testing into the hands of today's busy cataract and refractive practices. We knew we needed a solution that was portable, practical and precise. And over the last two years, we've been working on that solution. It's called the ScoutPro Osmolarity System. It's the first in the US, portable, handheld objective diagnostic test to help physicians identify at-risk osmolarity levels prior to refractive surgery, and also help patients evaluate and manage those lab results to determine therapy after surgery.

Adam Szaronos, President and CEO of Trukera Medical, discusses the recent rebranding of TearLab as well as the launch of the ScoutPro Osmolarity System.

Trukera Medical rebranding ushers in new era of expansion into cornea market

 Hi, I'm Dr. Mitch Shultz from Los Angeles, California, and I'm here to talk to you a little bit today about the study that I've done on the iStent inject versus the Hydrus stent.

We've actually been looking now we're getting close to presenting 2-year data on this study where we implanted patients, contralateral eyes, 1 eye with iStent inject and 1 eye with Hydrus and have followed the patients prospectively over the last 2 years.

The interesting thing that's come out of this data has really been that both products work extremely well as far as target IOPs. Both products have achieved a significant reduction in patient eye drop load but we found in patients who are implanted with either stent with just the implants, they typically get off approximately 1 medication. What has been interesting is in combination with ab interno canaloplasty, we have actually been able to improve that to 1 and a half to 2 medication reduction in medication burden.
Another important fact has been the fact that 80% of patients have are now medication-free. So that's been another feature of the study.

But what has really been critical and what's really kind of changed. The way I'm doing things today is the fact that we have less adverse events in our iStent group than we've had in the Hydrus group. So what we've seen in the iStent group is zero intraoperative adverse events and zero postoperative adverse events.

Unfortunately, in the Hydrus group, there are some learning curve problems that surgeons may experience with underimplantations, overimplantations, or missing the passage and going into the superciliary space, which can lead to other problems postoperatively. We've actually seen one patient with angle closure glaucoma occur after Hydrus stent.

So I think when we're looking for safety, efficacy, iStent inject has really stood out in this group, even though both stents work very well. So thank you very much, and I look forward to seeing you around the meeting.

At AAO 2022, Dr Mitch Shultz provides discourse on iStent inject vs Hydrus contralateral eye evaluation data.

2-year data in contralateral eye evaluation gives edge to iStent inject over Hydrus stent

The 2022 American Academy of Ophthalmology (AAO) Annual Meeting took place in Chicago, Illinois, US, from September 30-October 3. A combination of posters, podium presentations and instructional courses provided invaluable revelations to the ophthalmic community.

Higher incidence of new strabismus in paediatric patients following tube shunt surgery

Dr Maria A. Guzman Aparicio and Dr Teresa C. Chen, from Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, United States, found that paediatric patients have a significantly higher incidence of new-onset strabismus after tube shunt surgery for glaucoma compared with adults.

According to past literature, adults who undergo Ahmed (New World Medical) and Baerveldt (Abbott Medical Optics) tube shunt surgeries have postoperative strabismus 2% to 12.7% of the time after 1 to 5 years; in children, the percentages range from 3% to 4.2% with Ahmed valve surgery after 16 to 24 months of follow-up.

In their current study with longer follow-up periods, Drs Guzman Aparicio and Chen sought to compare the frequency of strabismus after tube shunt surgery in the adult versus paediatric populations and to identify risk factors for strabismus after tube shunt surgery.

Younger patients often require repeat corneal crosslinking, study finds

At the 2022 American Academy of Ophthalmology meeting, Dr Philip Dockery, MPH, presents, "Effectiveness of corneal crosslinking in young patients."

Comparing dry eye disease in adult and paediatric populations via the IRIS Registry

A study of dry eye disease (DED) in children found that the average age of onset of DED is at 12.51 years compared with the average of 61.06 years in adults. The highest prevalence in children was seen between 12 to 15 years of age, according to lead author Dr Vivian Paraskevi Douglas, DVM, MBA, MSc, and colleagues from Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, United States.

Although DED is highly prevalent in adults, with rates ranging from 5% to 50%, little is known about the disorder in paediatric patients, which sparked the interest in this study.

Pooled TENAYA, LUCERNE Phase 3 data reports safety, efficacy, lower treatment burden with faricimab for nAMD

The 2-year results of the TENAYA and LUCERNE studies indicated that faricimab (Vabysmo, Genentech), the first intraocular bispecific antibody that inhibits both angiopoietin-2 and vascular endothelial growth factor-A was safe and efficacious for treating neovascular age-related macular degeneration (AMD).

Dr Rishi Singh, FASRS, reported the highlights of the pooled results of the trials on behalf of the study investigators.

TENAYA and LUCERNE were Phase 3 global, randomized, double-masked 112-week trials designed to assess the efficacy, safety and durability of faricimab in treatment-naïve patients with neovascular AMD.

At week 60, patients in the faricimab arm were treated according to a protocol-driven treat-and-extend–based regimen.

Dr Singh reported that, compared with baseline, gains in vision and decreased central subfield thicknesses following treatment with faricimab out to every-16-week dosing were similar to those achieved with aflibercept (Eylea, Regeneron) with every-8-week dosing with fewer injections, through week 112.

Fluid dynamics in wet macular degeneration: How fluid type affects visual acuity

At AAO 2022, Dr Justis Ehlers presented a talk entitled, "Defining the Fluid Problem in Neovascular AMD: To Dry or Not to Dry?"

Retinal detachment rates following acute retinal necrosis are unaffected by early treatment with antivirals, vitrectomy

Dr Ines Lains, PhD, and colleagues from the Massachusetts Eye and Ear, Harvard Medical School, Boston, reported that adjunct treatment with intravitreal antivirals or early pars plana vitrectomy (PPV) did not improve the rates of retinal detachment (RD) in patients with acute retinal necrosis (ARN).

ARN is rare but can have devastating visual consequences, Dr Lains explained. Over time, patients with ARN have a high risk of developing retinal traction and necrotic retinal breaks, which can lead to the development of a RD.

“RD is one of the most common consequences of ARN,” she said. Systemic antivirals are the mainstay treatment for ARN, and even though clinicians may empirically add intravitreal antivirals or early PPV, data on this topic remains controversial.

Risk factors for developing rhegmatogenous retinal detachments in fellow eyes identified in study

William Kearney, MS, Dan Gong, MD, and colleagues from Massachusetts Eye and Ear, Harvard Medical School, Boston, identified risk factors for the development of rhegmatogenous retinal detachments (RRDs) in the fellow eye of patients who developed an RRD in one eye.

RRDs are sight-threatening conditions associated with potential morbidity, and patients with a unilateral retinal detachment frequently ask about the risk of developing an RRD in their fellow eye.

The investigators pointed out that this question is clinically relevant for identifying fellow eyes with an increased risk of developing an RRD and may help improve the ability to diagnose RRDs earlier. “This early diagnosis is essential since early repair increases the success rate of retinal reattachment surgery and improves visual outcomes,” Kearney said.

No negative effects in DMO patients reported following pandemic-imposed health care restrictions

Bryce Johnson, BS, and associates from the Department of Ophthalmology, University of Texas Southwestern Medical Centre, Dallas, found that to their surprise diabetic macular oedema (DMO), a leading cause of vision loss, was not negatively impacted by the changes imposed by the COVID-19 pandemic.

Because a healthy lifestyle is key to prevention of progression of DMO, they conducted a retrospective chart review to assess the impact of truncated medical services during the pandemic.

The study includes 570 patients who had been diagnosed with DMO between January 2019 and July 2021.

The parameters studied were haemoglobin A1c, body mass index, adherence to scheduled appointments, and need for therapy.

Is the robot-assisted procedure the future of MIGS?

Investigators from the Icahn School of Medicine at Mount Sinai, New York, United States, reported that robot-assisted microinterventional glaucoma surgery (MIGS) has potential for interventions in the anterior segment, according to Dr Gautam Kamthan, Assistant Director of Ophthalmic Innovation and Technology at New York Eye and Ear Infirmary of Mount Sinai. They reported the first such feasibility of robot-assisted ophthalmic gonio-surgery.

Dr Kamthan and co-investigators studied the potential for use of this approach by comparing robotic interventions preclinically to the standard manual approach in synthetic eye models for MIGS. Three robotic systems have been developed by theNew York Eye and Ear Robotics Program: the µ-RoboticGonio Surgery System, the T-Rexµ-RoboticFlexible Goniotomy and iStentµ-Robotic Implantation System.

A comparison of the surgical precision between manual and surgical procedures speaks to the rationale for robotic-assisted procedure. Manual procedures are characterized by 100-µm tremor peak-to-peak vector magnitude, 500 to 1,000-mN human finger force sensing resolution and 182-µm root mean square tremor amplitude with manual vitreoretinal surgery, Dr Kamthan explained.

Investigators report positive visual outcomes one year after monocular implantation of small aperture IOL

Dr Mark H. Blecher dives into his AAO 2022 topic: "One-Year Visual Outcomes Following Monocular Implantation with a Small Aperture IOL."

Utilising AAO cornea preferred practice patterns for corneal oedema, opacifications, ectasia and bacterial keratits

David Hutton discusses the AAO 2022 talk, "Corneal Oedema, Opacifications, Ectasia, and Bacterial Keratitis: Diagnosis and Treatment Strategies from the Preferred Practice Pattern Guidelines," with presenter Dr Francis S. Mah.

Increased smoking-related ocular symptoms linked to cigarettes than electronic cigarettes

Investigators from McGill University, Quebec, Canada, and Stanford University, Palo Alto, California, United States, reported that young smokers had more ocular symptoms resulting from cigarette smoking than those who smoked electronic cigarettes. However, those who used both reported severe to very severe ophthalmic symptoms, according to Anne Xuan-Lan Nguyen from McGill University, Quebec, Canada, first author of the study.

The investigators conducted an observational, cross-sectional online survey to determine the frequency and severity of ocular symptoms in young e-cigarette and cigarette users.

A total of 4,351 Americans aged 13 to 24 years responded to the survey questions regarding the use or non-use of nicotine e-cigarettes and cigarettes and the use during the previous 7 and 30 days.

Dual users were defined as those who used both products. The outcomes included the general vision status and frequency and severity of ocular symptoms that included ocular discomfort, pain, burning, itching, redness, dryness, glare, blurry vision, eye strain, and headaches.

Articles

A combination of posters, podium presentations and instructional courses provided invaluable revelations to the ophthalmic community.

AAO recap: Clinical trial updates, new innovations presented at America's biggest ophthalmic conference

When introducing genetic material into the target cell of a patient to prevent or cure a disease, one approach is to replace an otherwise mutated or missing gene with the correct coding sequence. Another is to inactivate or silence a mutant copy of the gene with a dominant negative or toxic effect (for example, using endonuclease/CRISPR-Cas9, ribozyme or antisense RNA). It is also possible to introduce therapeutically beneficial genetic material such as a ‘killer gene’ into tumours.

These three approaches were introduced by Prof. Isabelle Audo in one of her presentations at this year’s European Society of Retinal Specialists (EURETINA) Meeting on 3rd September in Hamburg, Germany, in the Session on “Inherited Retinal Diseases”. Prof. Audo is based at the Department of Genetics, Institut de la Vision, Paris, France.

However, there is another promising avenue available in gene therapy: optogenetics. In this case, the genetic material consists of light-sensitive proteins which can induce a biological process when exposed to light of a certain wavelength. This has potential in the progressive, inherited disease retinitis pigmentosa (RP), Prof. Audo explained.

The ongoing PIONEER Phase I/II study is a first-in-human dose escalation study that is investigating the optogenetics approach with the AAV2-based candidate GS030 (GenSight Biologics), which is delivered by a single intravitreal injection in the worst-seeing eyes of RP patients.

GS030 encodes the light-sensitive protein red-shifted channelrhodopsin. According to Prof. Audo, the gene is stimulated with an optoelectronic device consisting of a pair of engineered glasses, to transform an external light stimulus into a signal to activate the retinal ganglion cells and the retinal output is sent to the brain for image processing.

The clinical trial is being undertaken at is being at three sites in the United Kingdom (London), Paris (France) and United States (Pittsburg, Pennsylvania) and has enrolled 18 subjects between the ages of 18 and 75 with non-syndromic RP into three cohorts. Patients eligible for the study were affected by end-stage RP with no light perception or light perception levels of visual acuity. An extension cohort expanded the inclusion criteria by recruiting patients with hand motion and counting fingers levels of visual acuity.

The first cohort of patients (n = 3) received a dose of 5.0 x 1010 vector genomes, the second (n = 3) received 1.5 x 1011 vector genomes and the third cohort (n = 3) were administered with a dose of 5.0 x 1011 vector genomes. Dosing in these three cohorts has been completed and, following review by the independent Data Safety Monitoring Review Board, no safety issues were found. Based on this, the Board advised that the highest dose could be selected for the extension cohort, and one patient in this cohort is currently being reviewed in France.

In terms of efficacy data to date, Prof. Audo described by way of a video how a patient with late-stage RP in the second cohort partially recovered her visual function following treatment with a single dose. The patient had been diagnosed with RP 20 years prior to enrolment and, 12 months following injection in her worse-seeing eye, she could correctly locate objects of different sizes and contrasts on a white table in front of her, with a 57% success rate when wearing the light-stimulating goggles, versus 24% without the device.

The optogenetic candidate has been granted orphan drug designation in Europe and the United States.

Another company that is investigating the optogenetic approach in RP patients is Nanoscope Therapeutics. According to Prof. Audo, enrolment is complete in a Phase IIb trial, RESTORE, in 27 adult patients with a diagnosis of advanced RP.

In this trial, the experimental treatment is the ambient-light activatable multi-characteristic opsin MCO-010, delivered in a single intravitreal injection. There are two dose groups that comprise patients over the age of 18-years-old who have a confirmed diagnosis of advanced RP based on clinical examination, dilated fundus examination and genetic testing.

Enrolled patients had a best-corrected visual acuity worse than 1.9 LogMAR (Snellen equivalent of 20/1600), counts fingers/hand motion in the study eye and no better than 1.6 LogMAR (Snellen equivalent 20/800) in the fellow eye during screening. Patients also had the presence of retinal inner nuclear and nerve fibre layers detected on optical coherence tomography testing in the study eye during screening as determined by the investigator and confirmed by the sponsor or designee.

Patients will be assessed over 52 weeks and the primary outcome measures are the efficacy of a single intravitreal injection of vMCO-010 assessed by Y-Mobility test, and the type, severity and incidence of ocular and systemic adverse events, specifically those related to intravitreal injection of the candidate.

Dr Audo concluded by stating that in the future it should be possible to fine-tune the vectors to improve sensitivity and simulation and to target dormant cones to help restore vision.

EURETINA

Companies are exploring light-sensitive proteins method in patients with advanced disease.

Optogenetics approach could restore visual function in retinitis pigmentosa

The data analysis showed that the macular thickness decreased across all time periods and in all macular regions for all terciles. Most of the macular regions showed some decrease in the macular thickness, the results showed.

Stratification of the patients based on the patient adherence to scheduled appointments did not significantly change the results.

“The DMO did not worsen during the pandemic, and instead we saw a small but significant improvement,” they commented.

They hypothesized that more positive lifestyle changes during the pandemic, delays in retinal changes, and implementation of telehealth evaluation may be possible explanations for the study findings.

The data analysis showed that the macular thickness decreased across all time periods and in all macular regions for all terciles.

The investigators conducted a retrospective cohort study using the American Academy of Ophthalmology IRIS registry data from 2016 to 2020.

The study included 212,886 patients with a newly diagnosed RRD in one eye. The researchers collected data that included patient age, sex, race, geographic region, and smoking status.

The analysis found that 61.3% of patients were men (mean patient age, 60.7 years) who developed a new RRD in at least one eye.

A total of 6,826 (3.2%) developed an RRD in the fellow eye at a mean time of 406.5 days from the diagnosis of the RRD in the first eye, they reported.

Pars plana vitrectomy was the most common initial procedure (57.9%) performed to repair the RRD in the fellow eye, although 10.7% of patients required two or more procedures to reach that end.

The risk factors for developing an RRD in the fellow eye were as follows: male versus female sex (hazard ratio [HR], 1.74; 

< 0.001); younger age at first eye RRD diagnosis (HR 1.02, 

< 0.001), Asian versus Caucasian ethnicity (HR, 0.54; 

< 0.001); Black versus Caucasian race (HR, 0.55; 

< 0.001); active smoking status versus never smoked (HR, 1.12; 

 = 0.004); and Northeast versus Midwest residency (HR, 0.89; 

The investigators concluded, “In this cohort analysis of patients with a newly developed RRD in one eye, male sex, younger ageof first eye RRD diagnosis, and active smoking were associated with higher risk of developing a fellow eye RRD.”

Patients with a unilateral rhegmatogenous retinal detachment frequently ask about the risk of developing an RRD in their fellow eye.

Ms Nguyen reported that42.5% to 70.7% of all respondents reported no ocular symptoms.

Among dual uses, 1.1% to 3.9% reported severe to very severe symptoms; 0.9% to 4.3% of dual users reported frequent symptoms occurring daily. Both of these rates were significantly higher than among the respondents who used only e-cigarettes or only cigarettes (

 < 0.05). Those who used cigarettes alone reported more severe and frequent symptoms than those who used e-cigarettes alone (

The investigators pointed out that this large, population-based study offers new perspectives on ocular symptoms in young users of e-cigarettes and cigarettes.

“More severe and frequent ocular symptoms occurred in young Americans using both cigarettes and e-cigarettes. Dual users should cease and reduce their use of such products to prevent and minimize ocular risks,” the authors concluded.

They also recommended that health care providers document the use of smoking products in their patients, which may result in better prevention and counselling in the ophthalmic patient population.

Those who used both traditional and electronic cigarettes reported severe to very severe ophthalmic symptoms.

At week 112, more than 60% of patients treated with faricimab achieved every-16-week dosing and about 80% achieved every-12-week dosing or better.

Those who needed treatment every 8 weeks generally had worse baseline ocular characteristics versus extended treatment intervals, he pointed out.

“Early and rapid treatment interval extension with faricimab was associated with stable visual gains and anatomic outcomes through week 112,” Dr Singh commented. 

In support of this, the analysis showed that most patients on every-12-week dosing at week 60 achieved every-16-week-dosing at week 112.

Every-8-week dosing was associated with tight anatomic control, and most of these patients on every-8-week dosing at week 60 were on extended dosing intervals at week 112.

Faricimab was well-tolerated with an acceptable safety profile through week 112.

The AVONELLE-X long-term extension study will continue to evaluate the efficacy, durability and safety of faricimab in patients with neovascular AMD.

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