Optometric Physician



Vol. 24, #29 •   Monday, July 24, 2023


Off the Cuff: Exciting Developments in the Dry Eye Treatment Landscape

There has been significant movement in the dry eye space over the past several months including new approvals and acquisitions. These developments represent an exciting time in the field of dry eye care, as well as a dramatic shift. With all these developments, I have been telling many of my dry eye and ocular surface disease patients that although I wish they didn’t have dry eyes, now would be the best time because of the numerous treatment options at our disposal with many more on the way.


Bausch + Lomb saw the approval of Miebo, the acquisition of Xiidra from Novartis, and the Blink line of artificial tears from Johnson & Johnson Surgical Vision. By adding these new treatments to Lacrisert and Biotrue Hydration Boost lubricating drops, Bausch + Lomb has built a robust portfolio and has positioned itself as a leader in the dry eye space for the foreseeable future. For those unfamiliar with Miebo, it is perfluorohexyloctane, which is a water-free, semifluorinated alkane originally developed by Novaliq. Additionally, because it does not contain water, it is intrinsically preservative-free as microbes are unable to grow within it. From a mechanistic standpoint, Miebo essentially works as a tear film stabilizer as it helps prevent premature evaporation of the tear film, which makes Miebo the first FDA-approved drop to target the signs and symptoms of dry eye associated with MGD and evaporative dry eye. The pairing of Miebo with Xiidra makes perfect sense, as Bausch + Lomb now has treatment options for both the evaporative and inflammatory components of dry eye, respectively. I have been discussing Miebo with all my dry eye patients since its approval and the response has been one of overwhelming excitement, and I am looking forward to adding this drop to my treatment arsenal.

Vevye, which was originally developed by Novaliq and has been acquired by Harrow (which also just purchased Verkazia and Freshkote among other ophthalmic products from Santen), also recently received approval, and leverages the use of a water- and preservative-free semifluorinated alkane (in this case perfluorobutylpentane) as a vehicle for cyclosporine. Because this vehicle is water-free, has no pH or osmolarity, and contains no preservatives or surfactants, it does not disrupt the tear film and ocular surface. This vehicle allows for significantly increased contact time with the ocular surface increasing the bioavailability of the cyclosporine. This has traditionally been an obstacle for the naturally hydrophobic agent. This increased contact time allows for an improvement in signs and symptoms of dry eye in as little as four weeks. This represents a potentially major shift in the way we think about the traditionally slow-acting immunomodulator. Ideally, the days of waiting months to assess the efficacy of these medications will become a thing of the past.

Excitingly, the dry eye and ocular surface developments don’t end with Miebo and Vevye. Tarsus has a PDUFA (Prescription Drug User Fee Act) decision of approval date of August 25th for TP-03 (lotilaner ophthalmic solution), which would represent the first FDA-approved therapy for Demodex blepharitis. Additionally, we have a PDUFA date of November 23rd for Reproxalap by Aldeyra, an anti-inflammatory drop with a novel mechanism as a reactive aldehyde species inhibitor, which has been shown in clinical trials to provide rapid relief from dry eye-related inflammation. These represent therapies that will likely be available in the near future, and there are countless others in earlier stages of development that I plan on talking about more as they get closer to approval.

Cory J. Lappin, OD, MS, FAAO


Want to share your perspective?
Write to Dr. Shannon L. Steinhäuser, OD, MS, FAAO at ssteinhauser@gmail.com. The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of Jobson Medical Information LLC (JMI), or any other entities or individuals.



Unilateral COVID-19-Associated Vasculitic Central Retinal Vein Occlusion

This observational clinical case report describes a unilateral vasculitic central retinal vein occlusion (CRVO) in a young adult whose vision problems precede system symptoms of COVID-19 infection.

A 39-year-old immunocompetent male without prior ocular disease presented for vitreoretinal care complaining of decreasing vision in his right eye for two weeks. Headaches, pharyngitis and coughing began four days after his visual symptoms. COVID-19 testing was negative prior to initial vitreoretinal evaluation and positive afterward. Dilated and tortuous major retinal veins in his right eye had prominent perivascular sheathing. A large subhyaloid hemorrhage spanned the macula. Subretinal hemorrhages were present in areas of sheathing and diffuse nerve fiber layer hemorrhages were arrayed in the distribution of the radial peripapillary capillary plexus. Laboratory tests for inflammatory diseases were negative. The patient was hospitalized for COVID-19 pneumonia a few days after his initial vitreoretinal evaluation. Pars plana vitrectomy was performed for persistent subhyaloid hemorrhage eight weeks after his hospitalization. The visual acuity in the patient's right eye improved from CF to 20/30 postoperatively.

The patient's findings are consistent with an atypical CRVO which researchers hypothesized to be of vasculitic origin because of prominent associated retinal phlebitis and venous sheathing. Concomitant subhyaloid, nerve fiber layer and subretinal hemorrhages involved the superficial and deep retinal vascular complexes. The patient's COVID-19-related hospitalization and systemic management delayed surgical management of his subhyaloid hemorrhages but a good visual result was achieved despite persistence of macular pre-retinal blood for three months.

SOURCE: Dalla S, Mainster MA, Dalla KP, Ledesma-Gil G, Ajlan R. Unilateral COVID-19-associated vasculitic central retinal vein occlusion: phlebitis with subhyaloid, intraretinal and subretinal hemorrhages. Retin Cases Brief Rep 2023; Jul 13. [Epub ahead of print].



Retinal Neurodegeneration as a Potential Biomarker of Accelerated Aging in Schizophrenia Spectrum Disorders

Several biological markers are believed to reflect accelerated aging in schizophrenia spectrum disorders; however, retinal neural changes have not yet been explored as potential CNS biomarkers of accelerated aging in this population. The aim of this study was to determine whether retinal neural layer thinning is more strongly related to age in schizophrenia and schizoaffective disorder patients (SZ) than in a psychiatrically healthy control group (CON). Schizophrenia (n=60) and CON participants (n=69) underwent spectral domain optical coherence tomography (OCT) scans to examine the following variables in both eyes: retinal nerve fiber layer (RNFL) thickness, macula central subfield (CSF) thickness, macula volume, ganglion cell layer-inner plexiform layer (GCL-IPL) thickness, optic cup volume, and cup-to-disc ratio. Eleven participants in each group had diabetes or hypertension.

Significant negative relationships between age and RNFL thickness, macula volume, and GCL-IPL thickness were observed in the SZ group, while no significant relationships were observed in the CON group. However, many of the findings in the SZ group lost significance when participants with diabetes/hypertension were removed from analyses. A notable exception to this was that the age × SZ interaction accounted for a unique proportion of variance in GCL-IPL thinning over and above the effect of diabetes/hypertension.

The results suggested that retinal atrophy occurs at an increased rate in schizophrenia spectrum disorders, potentially reflecting accelerated aging inherent to these conditions, with considerable contributions from systemic medical diseases closely linked to this population.

SOURCE: Blose BA, Lai A, Crosta C, et al. Retinal neurodegeneration as a potential biomarker of accelerated aging in schizophrenia spectrum disorders. Schizophr Bull. 2023; Jul 17. [Epub ahead of print].

AI-Human Hybrid Workflow Enhances Teleophthalmology for the Detection of Diabetic Retinopathy

Detection of diabetic retinopathy (DR) outside of specialized eye care settings is an important means of access to vision-preserving health maintenance. Remote interpretation of fundus photographs acquired in a primary care or other non-ophthalmic setting in a store-and-forward manner is a predominant paradigm of teleophthalmology screening programs. Artificial intelligence (AI)-based image interpretation offers an alternative means of DR detection. IDx-DR (Digital Diagnostics Inc) is an FDA-authorized autonomous testing device for DR. Researchers evaluated the diagnostic performance of IDx-DR compared with human-based teleophthalmology over two-and-a-half years. Additionally, they evaluated an AI-human hybrid workflow that combines AI-system evaluation with human expert-based assessment for referable cases. Participants included diabetic patients ≥ 18 years old without a prior DR diagnosis or DR examination in the past year presenting for routine DR screening in a primary care clinic. Macula-centered and optic nerve-centered fundus photographs were evaluated by an AI algorithm followed by consensus-based overreading by retina specialists at the Stanford Ophthalmic Reading Center. Detection of more-than-mild diabetic retinopathy (MTMDR) was compared with in-person examination by a retina specialist.

The AI algorithm had higher sensitivity (95.5% sensitivity; 95% confidence interval [CI], 86.7%-100%) but lower specificity (60.3% specificity; 95% CI, 47.7%-72.9%) for detection of MTMDR compared with remote image interpretation by retina specialists (69.5% sensitivity; 95% CI, 50.7%-88.3%; 96.9% specificity; 95% CI, 93.5%-100%). Gradability of encounters was also lower for the AI algorithm (62.5%) compared with retina specialists (93.1%). A 2-step AI-human hybrid workflow in which the AI algorithm initially rendered an assessment followed by overread by a retina specialist of MTMDR-positive encounters resulted in a sensitivity of 95.5% (95% CI, 86.7%-100%) and a specificity of 98.2% (95% CI, 94.6%-100%). Similarly, a 2-step overread by retina specialists of AI-ungradable encounters improved gradability from 63.5% to 95.6% of encounters.

Researchers wrote that implementation of an AI-human hybrid teleophthalmology workflow may both decrease reliance on human specialist effort and improve diagnostic accuracy.

SOURCE: Eliot R Dow, Nergis C Khan, Karen M Chen, et al. AI-Human Hybrid Workflow Enhances Teleophthalmology for the Detection of Diabetic Retinopathy. Ophthalmol Sci; 2023; May 12;3(4):100330.



Industry News

Harrow Acquires U.S. and Canadian Commercial Rights to Vevye 0.1% from Novaliq, Acquires Santen’s Branded Ophthalmic Portfolio

Harrow announced an agreement under which Harrow will acquire the U.S. and Canadian commercial rights for Vevye (cyclosporine ophthalmic solution) 0.1%, a patented, non-preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol water-free technology. Read more.
In addition, Harrow announced the signing of agreements with affiliates of Santen Pharmaceutical under which Harrow will acquire certain U.S. and Canadian commercial rights for the following branded products from Santen. Read more.

Prevent Blindness Offers Art Therapy Program for Thyroid Eye Disease Patients & Care Partners

Learn more.








Journal Reviews Editor:
Shannon L. Steinhäuser, OD, MS, FAAO

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