Aramis Biosciences Inc. this week announced that the FDA has cleared the Investigational New Drug (IND) application for A197, enabling the company to proceed with a Phase II proof of concept clinical trial.

David S. Tierney, MD, Aramis Biosciences’ president and CEO, said the company is pleased that FDA has cleared A197 to move into Phase II clinical trials in dry eye patients.

“We believe that A197, with its novel mechanism of action targeting the immunopathogenesis of the disease and clean tolerability profile, has the potential to significantly improve the standard of care in dry eye disease,” he said in a statement. “With less than 5 percent of dry eye patients satisfied with available treatments, we look forward to moving this promising investigational therapy into the clinic.”

Aramis in December announced its launch and the completion of a $10.5 million Series A financing led by Safar Partners with a strategic investment from a global leader in ophthalmic pharmaceuticals.

The company is using proceeds from the financing to advance A197, a novel, first-in-class, topical immunomodulatory agent licensed from Dompé farmaceutici, through Phase II clinical proof of concept for the treatment of dry eye disease.

“Dry eye disease is the leading non-refractive reason why patients seek eye care, but less than 5 percent of patients are currently treated with an FDA-approved product due to suboptimal efficacy and tolerability limitations commonly associated with these products,” said Reza Dana, MD, MPH, MSc, scientific co-founder of Aramis.

Articles

According to the company, A197 is a novel, first-in-class, topical immunomodulatory agent which will move into Phase II clinical trials in dry eye patients.

Aramis Biosciences announces FDA clearance of IND application for A197

iSTAR Medical announced initial positive progress of MINIject in its US STAR-V trial.

According to the company, MINIject is a minimally-invasive glaucoma surgery (MIGS) implant and the only commercially available supraciliary MIGS device. The trial is now initiated in 13 sites across the U.S.. with positive feedback on initial implantations from world-leading glaucoma surgeons.

The company also noted that MINIject has demonstrated meaningful and enduring IOP reduction, combined with a favorable safety profile, in completed and ongoing trials conducted in Europe, the Americas and Asia in more than 150 patients so far.

 trial is a US FDA-approved pivotal study assessing the safety and efficacy of MINIject in over 350 patients with primary open-angle glaucoma across the US, Canada and Europe. Following the trial’s 

 in 2021, patient enrollment has been progressing as planned.

On the heels of the approval in MINIject in Europe, Michel Vanbrabant, CEO of iSTAR Medical noted that the company is pleased with the progress of its U.S. trial.

“We remain very encouraged by the strong feedback from clinicians so far, and we are confident that our STAR-V trial will build on the safety and efficacy outcomes demonstrated by MINIject in the STAR-I to STAR-IV trials,” he said.

According to Steven D. Vold, MD, a glaucoma specialist from Vold Vision in Fayetteville, Arkansas, and a STAR-V trial investigator, there is significant untapped potential in targeting the supraciliary space when leveraging MIGS to treat glaucoma, and MINIject enables this to be captured.

“iSTAR Medical’s approach uses its unique silicone micropore tissue friendly STAR material that enables biointegration,” he said in a statement. “The supraciliary space has previously been demonstrated to be one of the most efficacious targets, and I am excited at the prospect of having a new MIGS approach with such strong potential to offer my patients.”

Brian E. Flowers, MD, a glaucoma specialist at Ophthalmology Associates in Forth Worth, Texas, and an investigator in STAR-V, pointed out that MINIject’s highly biocompatible anti-fibrotic technology enables safe and meaningful IOP reduction for patients, without compromising corneal health.

“Additionally, it doesn’t require a bleb, reducing post-implantation patient management and potential complications,” Flowers said in a statement. “Overall, based on my implantations to date, I am encouraged by MINIject’s potential to be a game-changing MIGS device in the stand alone setting to improve disease management and quality of life in glaucoma patients.”

According to William J. Flynn, MD, from Eye Associates Research in San Antonio, Texas, the potential efficacy and safety means that MINIject may open the door to treating a much larger patient population who previously could not be treated by other MIGS devices.

“ I am excited to be part of this trial and based on my positive experience thus far, I am optimistic for MINIject to be a valuable addition to our glaucoma treatment armamentarium,” he concluded.

The pivotal trial of MINIject, STAR-V, now initiated in 13 sites across the US, has received positive feedback from glaucoma surgeons involved in the trial. 

iSTAR Medical shows initial positive progress of US STAR-V trial for MINIject

COVID-19 is associated mostly with respiratory symptoms; however, the nervous system also can become involved and, interestingly, this can occur despite a negative nasopharyngeal swab.

Informed guidelines are needed to diagnose and treat COVID-19 patients with neurologic manifestations, according to Maryam Salman, a fourth-year medical student studying at the Royal College of Surgeons in the Ireland-Medical University of Bahrain.

These neurologic manifestations have been reported to include headache, paresthesia, anosmia, ageusia, neuralgia, and dizziness and rarely meningoencephalitis, seizures, and immune-mediated neurologic diseases.1,2

Salman and her colleagues investigated the clinical characteristics of patients whose cerebrospinal fluid (CSF) was positive for SARS-CoV-2, with the hope of gaining a better understanding of the viral pathophysiology as it is related to neuropsychiatric manifestations.

The investigators conducted a search of various medical/scientific databases in August 2020 to identify original studies of patients who tested positive for SARS-COV-2 in their CSF.

The authors identified 525 studies, of which 56 were full-text articles. Of those, 14 articles were ultimately included in the assessment.

Salman and her team reported that 14 patients had CSF that was positive for the SARS-CoV-2 virus. Of the 14 patients, 3 (21.4%) had negative nasopharyngeal swabs despite the positivity of the CSF.3

Two of the 14 patients with positive nasopharyngeal swabs developed neurologic deterioration after they were thought to have recovered from the virus based on negative nasopharyngeal swabs. However, the CSF remained positive for the virus.

The common symptoms exhibited by the 14 patients, according to the authors, were headache (42.8%), fever (35.6%), vomiting (28.6%), cough (28.6), visual disturbances (28.6%), diarrhea (21.4%), and seizures (21.4%).

Four patients (28.6%) were admitted to the intensive care unit, one (7.14%) to a rehabilitation facility, and two (14.3%) died.

Despite the recognition of the positive CSF results, the authors pointed out that the literature does not contain sufficient data to facilitate formation of guidelines.

“More evidence is needed to improve our understanding regarding how results of lumbar puncture influence clinical decision-making in a case series of patients with COVID-19 even if SARS-CoV-2 is not detected in the CSF,” the investigators said.

Salman and her team also noted that more information is needed regarding how clinicians can use information gained from lumbar puncture, such as cell counts and infectious workup, in the management of COVID-19.

“Physicians should be familiar with the presenting neurological features of COVID-19, and be aware that they can occur despite a negative [nasopharyngeal] swab,” the investigators concluded. “The results of this study are intended to aid in the development of informed guidelines to diagnose and treat COVID-19 patients with neurological manifestations,” the authors commented.

1. Ellul MA, Benjamin L, Singh B, et al. Neurological associations of COVID-19. 

 2020;19:767–83{Ellul, 2020 #17}. doi:10.1016/S1474-4422(20)30221-0

2. Chen X, Laurent S, Onur OA, et al. A systematic review of neurological symptoms and complications of COVID-19. 

3. Salman MA, Mallah SI, Khalid W, et al. Characteristics of patients with SARS-CoV-2 positive cerebrospinal fluid: a systematic review. Int J Gen Med 2021;2021:10385-95; doi: https://doi.org/10.2147/IJGM.S333966

Informed guidelines are needed to diagnose and treat COVID-19 patients with neurologic manifestations, according to investigators.

Neurologic features of COVID-19 may be present without positive nasal swabs

The application of mitomycin C (MMC) after corneal cross-linking (CXL) does not prevent development of corneal haze after the procedure, but it does contribute to development of more corneal haze, according to Shady T. Awwad, MD, professor of clinical ophthalmology at the American University of Beirut Medical Center, in Lebanon.

The rationale for applying MMC after CXL has been the inhibition of incoming keratocytes following the procedure. However, abundant cytokine release from a surge in apoptosis due to the combination of CXL and MMC seems to be responsible for the development of more haze.

Awwad and colleagues reached this conclusion based on the results of a retrospective, single-center study of 72 patients (87 eyes with keratoconus) who underwent CXL from June 2013 to January 2015 at the American University of Beirut Medical Center. The same surgeon performed all CXL procedures using the Dresden protocol. MMC was applied at the end of each CXL procedure as part of the routine protocol from February 2015 to December 2015.

The results obtained from the patients treated with CXL alone was compared with the patients who underwent CXL and application of MMC. All patients were followed for 1 year and underwent periodic examinations during that period. The clinicians used Cirrus high-definition optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec AG) to monitor the stromal haze. Optical coherence tomography (OCT) sections of stromal haze were analyzed using a patented machine learning algorithm, developed and published by the authors, to automatically detect and objectively stage areas of stromal haze. The visual results were slightly better without MMC—but not significantly so—and the topographic results with/without MMC were significantly better compared with preoperatively.

According to Awwad, the overall anterior stromal haze was significantly (

 < .05 for all comparisons) greater at all postoperative time points (ie, at 1, 3, 6, and 12 months when MMC was applied compared with when CXL alone was performed). The mean gamma-decoded anterior stromal reflectivity on OCT scans was 26.0 ± 15.0 vs 14.8 ± 04.7 gray scale units at 1 month and 18.4 ± 9.3 vs 13.9 vs 4.4 at 12 months.

Analysis of the middle stromal reflectivity indicated that haze was significantly greater at the 12 month time point but did not reach significance at any time in the posterior stroma. The reflectivity of the anterior stromal haze area (which is selected by the software as displaying more haze than the surrounding area), calculated as the mean pixel intensity in a particular corneal region, was 33.1 ± 16.6 vs 23.2 ± 05.9 at 1 month and 27.1 ± 12.8 vs 20.6 ± 07.9 at 12 months for the CXL with MMC and the CXL groups, respectively (

Awwad concluded by raising another area for consideration, notably the implications of this study on simultaneous photorefractive keratectomy plus CXL candidates, where the value and potential risks of MMC should be critically appraised.

Awwad has no financial disclosures related to this content.

The application of mitomycin C after corneal cross-linking does not prevent development of corneal haze after the procedure, but it does contribute to development of more corneal haze.

MMC increases corneal haze after CXL

Canadian researchers are reporting that COVID-19 may have more detrimental effects than previously thought.

The noteworthy finding is that patients with mild-to-moderate cases of the virus who were not hospitalized had worsening mobility and difficulties in physical functioning, according to first author Marla Beauchamp, PhD, from the School of Rehabilitation Science, faculty of Health Sciences, at the Labarge Centre for Mobility in Aging, and the McMaster Institute for Research on Aging at McMaster University in Hamilton, Ontario, Canada.

This finding underscores the need to both determine the impact of the virus over the long term and to develop and implement effective interventions and management to address persistent deficits in mobility and functioning in this patient population, she and her colleagues emphasized in their report published in the 

Beauchamp and her colleagues analyzed data from the Canadian Longitudinal Study on Aging (CLSA) COVID-19 Study that began in April 2020 and data obtained before the pandemic from the first CLSA from 2015 to 2018. The patients completed exit questionnaires between September and December 2020. The participants were middle-aged and older individuals (> 50 years) who lived in Canadian communities. The main outcome measure was the change in mobility since the beginning of the COVID-19 pandemic at the exit interview. The data were analyzed from February 2021 to May 2021.

The analysis of this population-based cohort study, which included more than 24,000 people who were 65 years or older found that of the 2748 individuals who had confirmed, probable, or suspected COVID-19, 113 (94.2%) were not hospitalized.

“Individuals with confirmed or probable COVID-19 had higher odds of worsening mobility in terms of ability to engage in household activity (odds ratio [OR], 1.89; with a 95% confidence interval [CI], 1.11-3.22), physical activity (OR, 1.91; 95% CI, 1.32-2.76), and standing up after sitting in a chair (OR, 2.33; 95% CI, 1.06-5.11) compared with adults without COVID-19 during the same pandemic time period,” the investigators reported.

Among the patients with suspected cases of COVID-19, the findings were similar (for example, household activity OR, 2.09; 95% CI, 1.82-2.41).

The investigators concluded, “This cohort study among older adults in Canada found that receiving a COVID-19 diagnosis was significantly associated with worse mobility and functioning outcomes even in the absence of hospitalization. These findings suggest that interventions may be needed for individuals with mild to moderate COVID-19 who do not require hospitalization.”

1. Beauchamp MK, Joshi D, McMillan J, et al. Assessment of functional mobility after COVID-19 in adults aged 50 years or older in the Canadian Longitudinal Study on Aging. JAMA Netw Open 2022;5(1):e2146168. doi:10.1001/jamanetworkopen.2021.46168

COVID-19: Mobility, physical functioning impaired in older patients with mild, moderate cases

Thyroid eye disease (TED) is a rare autoimmune condition that is associated with Graves disease and is vision-threatening, making its identification all the more important, according to Gary Lelli, MD, vice chairman of ophthalmology at Weill Cornell Medical College in New York, New York.

Although this association is recognized, TED and Graves disease are 2 separate entities. “The TED component,” Lelli said, “can occur in up to 50% of patients with Graves disease, but also in hypothyroid and normal thyroid levels.”

In addition, TED occurs much more often in women—that is, as much as 5 times more often—and more in the fourth decade of life. A second peak can occur in older patients in their sixth decade of life.

In addition, smokers are much more likely to develop TED and have a longer period of inflammation from TED as well as a more severe disease course. The inflammation that develops in TED around the eye and eye socket can cause progressive changes, resulting in functional vision disorders, patient discomfort, and changes in patient appearance over relatively short periods of weeks to months, Lelli explained.

A menu of symptoms accompanies TED, such as severe dry eye, ocular redness and irritation, ocular bulging, eyelid retraction, and blurry vision. The characteristic inflammation associated with TED can impact the ocular muscles, resulting in diplopia and a detrimental effect on daily activities, such as reading and driving.

In the most severe cases, inflammation can cause compression of the optic nerve, resulting in visual loss. This most severe result can occur in approximately 2% to 5% of patients. Inflammation also can affect the normal fat behind the eyes and cause hypertrophy. This scenario is involved with ocular bulging. Swelling that is related to the fat hypertrophy also can be apparent in the lower and upper eyelids.

Lelli emphasized that an evaluation conducted by the appropriate specialist is the most important factor in diagnosing and managing this patient population. A history of any thyroid imbalance, especially a history of Graves disease, should signal an evaluation by an oculoplastic surgeon or a neuro-ophthalmologist.

Early treatment and putting a team of clinicians in place that includes—in addition to the oculoplastic surgeons and neuro-ophthalmologist—an endocrinologist, a strabismus specialist, and in some cases a psychiatrist or psychologist to assist with the emotional problems that accompany drastic changes in appearance are most beneficial, Lelli advised.

Because TED has a variety of presentations, the first step is categorization of the patient regarding the disease stage, degree of inflammation, specific ocular symptoms, and presence of any aesthetic changes. Establishing this base of information then leads to determination of the appropriate treatment, Lelli said.

Treatment ranges from addressing symptoms with dry eye drops, for example; antioxidants to decrease the inflammation; oral or intravenous anti-inflammatories; and surgery to relieve ocular bulging, eyelid retraction, and diplopia. “There is a wide range of treatment options, but they hinge on assembling the right team of clinicians who can properly diagnose and categorize patients,” he said.

Although there currently is no cure for TED, Lelli reported that more targeted treatments for patients are in the offing.

“A lot of the disease and orbital inflammation occur at the level of the orbital fibroblasts, receptors that are targeted by the autoimmune process to create inflammation,” he said. “We have ways to target those, and more research is being done. We can make the disease substantially more tolerable for patients.”

The second TED awareness week was held this year, with a focus of disseminating more information about TED to patients and clinicians alike. A small percentage of patients with TED (ie, 5%-10%) have hypothyroidism, and a baseline examination is warranted.

The goal is to provide information to patients, ophthalmologists, and other eye care clinicians to raise their awareness of TED signs and symptoms in patients who have a history of thyroid disease, according to Lelli. A referral to an oculoplastic surgeon or neuro-ophthalmologist may catch the disease early in the process.

Lelli advises that clinicians who have patients with Graves disease or a thyroid condition should look for the signs and symptoms of TED. If a clinician is suspicious that a patient may have TED, speed is of the essence. An early evaluation by specialists can help get the patients on the right treatment path if warranted. Lelli also suggested the website, focusonted.com, to provide useful information about the disease for patients and doctors as well as specialists listed by ZIP code.

Lelli has no proprietary interest in any aspect of this report.

An evaluation conducted by the appropriate specialist is the most important factor in diagnosing and managing this patient population. 

Focusing on TED: Rare but devastating

 is in private practice at Harvard Eye Associates in Laguna Hills, California, and serves as a clinical instructor at the UCLA Stein Eye Institute. He is a paid consultant for Allergan, EyePoint Pharmaceuticals, and Glaukos Corporation and has an equity interest in MDbackline.

To control pain and inflammation most effectively and responsibly for our cataract surgery patients, we must not only use the appropriate drugs but also ensure they are delivered in the most beneficial manner. We should be mindful of the implications of our pharmaceutical strategies and their impact on our patients.

The opioid crisis in this country may have taken a back seat to the COVID-19 pandemic in terms of headlines, but it certainly has not faded. If anything, it has worsened. Nearly 50,000 people in the United States died from opioid-involved overdoses in 2019, according to the National Institute on Drug Abuse.1 Around 21% to 29% of patients who are prescribed opioids for chronic pain misuse them, between 8% and 12% of people using an opioid for chronic pain develop an opioid use disorder, and an estimated 4% to 6% who misuse prescription opioids transition to heroin.

The chances of developing an opioid use disorder depends on factors, such as length of time one is prescribed opioids for acute pain and length of time that people continue taking the drug. In the United States, the total economic burden of prescription opioid misuse is estimated to be $78.5 billion a year, according to the Centers for Disease Control and Prevention.

It has been reported that opioid-naïve cataract surgery patients who receive an opioid prescription within 7 days of surgery are 1.6 times more likely to be using opioids long-term than those who are not prescribed an opioid following cataract surgery.

 Being older than 50 is a risk factor for chronic opioid use following surgery, therefore most cataract surgery patients are considered at greater risk of opioid dependency.

 It is clear that ophthalmologists, like other physicians, should seek to avoid prescribing opioids whenever possible.

Our cataract patients frequently struggle to adhere to complex postoperative drop regimens. We commonly prescribe 3 different agents—a nonsteroidal anti-inflammatory drug (nSAID), a steroid, and an antibiotic—and expect them to instill these drops as directed. This is a problem, as we know patients do not use their medications properly, with adherence being a major obstacle.

 In fact, 1 study showed that as many as 92% of patients do not correctly instill drops, being hindered by manual dexterity problems and other physical limitations.8 We surgeons seek to not only control pain and inflammation but also prevent it to ensure the best patient experience and optimal visual outcomes, particularly in the setting of premium IOLs.

Today we have the option of adopting delivery platforms that require no effort on the part of patients—this is a sea change in our strategies. One such option is preservative-free Dextenza, a dexamethasone 0.4-mg intracanalicular insert made of a resorbable polyethylene glycol–based hydrogel. The insert is placed within the canaliculus to provide a hands-free and tapered delivery of drug to the ocular surface. It can be inserted preoperatively or intraoperatively, and it takes just 1 minute to do. The highest concentration of dexamethasone is released during the first 2 weeks, and it slowly tapers over a period of about 1 month. The insert demonstrated a retention rate of 99% in the punctum at day 14 in the studies. Phase 3 studies showed there were no significant IOP spikes with the dexamethasone 0.4-mg intracanalicular insert compared with placebo.

Certainly, if there was a concern, the insert can be easily explanted. Regarding pain and inflammation in the phase 3 studies, a significantly greater proportion of eyes in the dexamethasone 0.4-mg intracanalicular insert group had an absence of ocular pain and an absence of anterior chamber cells, compared with the placebo group.

Many surgeons have found they can go completely dropless by combining Dextenza with intracameral moxifloxacin—particularly if they also use intraoperative ketorolac and phenylephrine (Omidria; Omeros). The nSAID lasts for 2 to 3 days, which is adequate for a significant number of patients. In my practice, I have moved to using just 1 postoperative drop for 3 to 4 weeks: once-daily bromfenac (Prolensa; Bausch + Lomb).

Eric Donnenfeld, MD, and I conducted a study comparing the 3-drop regimen with a dropless or near dropless strategy in 56 patients and found that patients overwhelmingly favored the latter regimen (96%). There was no significant difference in patient-reported pain or inflammation as seen on optical coherence tomography, no IOP concerns, and it was less expensive. In other words, the dropless or near dropless approach checked every box.

Although the benefits of sustained-release dexamethasone go well beyond their eliminating need for opioid medications after cataract surgery, avoiding opioids is still a strong and important reason surgeons should consider embracing use of the insert. As a specialty, we need to remain sensitive to the use of narcotics as well as opportunities we have to proactively reduce pain. The amount of effort it takes to incorporate dropless or near dropless cataract surgery into surgeons’ practice is well worth the numerous benefits they and their patients will reap.

Hovanesian is in private practice at Harvard Eye Associates in Laguna Hills, California, and is a clinical instructor at Jules Stein Eye Institute at the University of California, Los Angeles. Find him online @DrHovanesian. Hovanesian is a consultant for Ocular Therapeutix, EyePoint Pharmaceuticals, Omeros, and several other manufacturers of ophthalmic drugs and devices.

1. Opioid overdose crisis. National Institute on Drug Abuse. Accessed October 29, 2021. https://www.drugabuse.gov/drug-topics/opioids/opioid-overdose-crisis

2. Donnenfeld ED, Shojaei RD. Effect of intracameral phenylephrine and ketorolac 1.0%/0.3% on intraoperative pain and opioid use during cataract surgery. 

. 2019;13:2143-2150. doi:10.2147/OPTH.S229515

3. Okeke CO, Quigley HA, Jampel HD, et al. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. 

 2009;116(2):191-199. doi:10.1016/j.ophtha.2008.09.004

4. Richter A, Anton SF, Koch P, Dennett SL. The impact of reducing dose frequency on health outcomes. 

2003;25(8):2307-2306. doi:10.1016/s0149-2918(03)80222-9

5. Tsai T, Robin AL, Smith JP 3rd. An evaluation of how glaucoma patients use topical medications: a pilot study. 

6. Robin AL, Novack GD, Covert DW, Crockett RS, Marcic TS. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. 

. 2007;144(4):533-540. doi:10.1016/j.ajo.2007.06.012

7. Jones J, Francis P. Ophthalmic utility of topical bromfenac, a twice-daily nonsteroidal anti-inflammatory agent. 

. 2009;10(14):2379-2385. doi:10.1517/14656560903188425

8. An JA, Kasner O, Samek DA, Lévesque V. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. 

. 2014;40(11):1857-1861. doi:10.1016/j.jcrs.2014.02.037

9. Tyson SL, Bafna S, Gira JP, et al; Dextenza Study group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. 

. 2019;45(2):204-212. doi:10.1016/j.jcrs.2018.09.023

10. Walters T, Bafna S, Vold S, et al. Efficacy and safety of sustained release dexamethasone for the treatment of ocular pain and inflammation after cataract surgery: results from two phase 3 studies

 2016;7:1000572. doi:10.4172/2155-9570.1000572

Donnenfeld E, Hovanesian J, Hummel C, Quintero J. Dropless punctal plug dexamethasone, intracameral ketorolac and moxifloxacin compared to conventional topical therapy in cataract surgery. Presented at: ASCRS 2020 Virtual Annual Meeting; May 16-17, 2020.

Removing burden of adherence, opioids from patients

The biped.ai smart harness. Image courtesy of biped

Swiss-start-up biped recently demonstrated its AI-co-pilot for blind and visually impaired people during the Consumer Electronics Show 2022 in Las Vegas.

According to the company, biped.ai includes a comfortable and lightweight collar fitted with 3D cameras that continuously monitor a 170° field of view for the user detecting, tracking and predicting the trajectories of all surrounding elements a few seconds in advance. It then filters the relevant information and warns the wearer via immersive 3D sounds.

“This mirrors the way autonomous vehicles work,” CEO and co-founder Mael Fabien said in a statement. “biped will, for example, warn a user about a bike 12 meters ahead on the user’s trajectory, but ignore an object that is closer but with no collision risk.”

According to the release, biped was formed in January 2021 after Fabien met his co-founder and CTO Bruno Vollmer at the International Create Challenge hackathon in Switzerland.

“I was both inspired by my research and by working next to the main ophthalmic hospital in Lausanne,” Fabien said in the release. “Every day I would encounter blind and visually impaired people and wondered if we could go beyond sticks and guide-dogs to help them.”

Further research revealed that only 5% of the estimated 5 million fully blind people in Europe and the US would take up the option of a guide-dog. Furthermore, the biped team also discovered that younger people are interested in solutions that are less stigmatizing than a stick.

Fabien pointed out that the company worked extensively with trialists on the user-friendliness of biped and the model shown recently at CES incorporates their feedback. The collar weighs under 1 kg and can be worn over any thickness of clothing – from t-shirts to parkas – and has no clips or special fastenings. It also looks like a rucksack strap rather than a medical device. The signals are transmitted through comfortable bone conduction earphones and the system can also connect to mobile apps to use GPS.”

According to the company, it recently closed a $1.1 million seed round from Swiss and French business angels and a Swiss VC and is now filing for Class I medical device status.

Fabien added that the company’s goal is to launch first in Switzerland in Q2 and then the US in early 2023.

“Sales will be either direct or by monthly subscription,” Fabien concluded. “We also see an opportunity for campuses and large companies to loan bipeds to visitors. Overall, we hope to make a major difference to the quality of life for blind and visually impaired people worldwide.”

According to the company, biped.ai includes a comfortable and lightweight collar fitted with 3d cameras that continuously monitor a 170° field of view for the user detecting, tracking and predicting the trajectories of all surrounding elements a few seconds in advance.

Biped unveils smart harness to help visually impaired people avoid obstacles while walking

For many people, inherited retinal degeneration can make even the most mundane tasks—like cooking, driving and walking down the sidewalk—difficult or impossible, and it cannot be cured.

—have spent the last several years collaborating to study proteins called Musashi, the loss of which causes rapid retinal degeneration. Their project recently received its fifth year of funding—$502,444—from the National Eye Institute, a division of the National Institutes of Health.

According to Stoilov, an associate professor in the Department of Biochemistry, a key issue with treating retinal disease is that it is such a scattered target that you cannot hit it with just one therapy. ”

“Retinal disease is caused by hundreds of genetic mutations in tens of different genetic loci, and so you need to treat each mutation individually,” he said in a news release. “We think once we have a good understanding of what Musashi proteins do and how to manipulate their function, we can develop a universal therapy for blinding diseases.”

According to the news release, the Musashi proteins are two very similar RNA-binding proteins found in all vertebrates. Earlier work by Stoilov and Ramamurthy revealed that Musashi proteins are critical for photoreceptor development and survival. Now they’re exploring what exactly Musashi proteins do on a molecular level that’s so important to photoreceptor health.

The researchers want to determine if the Musashi are controlling protein translation in the retina directly and investigate the role the proteins play in regulating gene suppression.

“I think the hardest task in this grant is to assign a weight to all these different potential mechanisms,” Stoilov said in the release. “How important is direct regulation versus indirect regulation? And these hypotheses may not be mutually exclusive.”

Treatment options for people with retinal degenerative diseases are limited—and expensive—because they only work when certain mutations are present.

“A reduction in the production of proteins needed for vision is frequently associated with human blindness,” said Ramamurthy, a professor with the 

Department of Ophthalmology and Visual Sciences

 and chair of the Department of Biochemistry. “Our studies on Musashi will identify potential pathways to boost protein production and slow vision loss.”

According to the news release, Stoilov and Ramamurthy trust that a greater understanding of the processes leading to retinal degeneration and blindness will bring about more universally-effective and cheaper therapies for those who have retinal degenerative diseases.

“I think the results of this project will give us a global, very good fundamental understanding of what happens during retinal degeneration,” Stoilov concluded in the release. “That is universal, and it can be applied broadly to retinal degeneration regardless of what the immediate cause is.”

According to researchers, gaining a good understanding of what Musashi proteins do and how to manipulate their function could lead to the development of  a universal therapy for blinding diseases.

WVU receives funding from the National Eye Institute to dissect the mechanism of retinal degeneration

Patients implanted with diffractive multifocal IOLs had notable declines in the corrected distance visual acuity (CDVA), distance corrected near VA (DCNVA), and near area of focus (AoF) with aging, according to Ryo Terauchi, MD, and associates from the Department of Ophthalmology at the Jikei University School of Medicine in Tokyo, Japan.

The investigators compared the effects of aging in this patient population by dividing patients who had been implanted with diffractive multifocal IOLs into the following 4 groups: those under 50 years of age, 50 to 59 years, 60 to 69 years, and 70 to 79 years.

The CDVA, DCNVA, and an area of focus metric, i.e., the distance, intermediate, and near AoF were measured postoperatively and compared among the age groups.

The respective CDVAs in the 4 age groups declined with age: −0.18, −0.16, −0.14, and −0.10 logarithm of the minimum angle of resolution (logMAR). In patients in their 70s, the CDVA was significantly worse compared with those younger than 50 years and those in their 50s (p = 0.002 and p = 0.049, respectively), Dr. Terauchi reported.

He also reported that the respective DCNVAs in the 4 age groups showed the same trend: 0.01, 0.03, 0.03, and 0.08 logMAR. The DCNVA in the oldest group was significantly worse than those in patients younger than 50 years and those in their 60s (p = 0.008 and p = 0.019, respectively).

Finally, the near AoF was smaller in the oldest patients compared with the patients younger than 50 years and those patients in their 50s (p = 0.040 and p = 0.047, respectively). No significant differences were seen in the intermediate and distant AoFs in the 4 groups. However, in patients over 60 years of age, a “steep” decline was seen in the AoF.

Terauchi R, Horiguchi H, Ogawa S, et al. Age-related visual outcomes in eyes with diffractive multifocal intraocular lenses. Eye 2021; https://doi.org/10.1038/s41433-021-01854-x

According to investigators, patients implanted with  diffractive multifocal IOLs had notable declines in the corrected distance visual acuity, distance corrected near VA, and near area of focus with aging

Biped unveils smart harness to help visually impaired people avoid obstacles while walking

WVU receives funding from the National Eye Institute to dissect the mechanism of retinal degeneration

Study finds progressive declines in vision in aging patients with diffractive multifocal IOLs