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COVID-19: Year in the life of ophthalmology practice

Iridex Corp. this week unveiled a strategic collaboration with Topcon Corp. which will see the Japanese-based manufacturer and distributor invest in Iridex by purchasing exclusive rights to distribute retina and glaucoma products in certain global markets and acquiring a 10.4% common equity stake in the company.

The collaboration nets $19.5 million of cash to Iridex, providing multiyear funding for strategic growth initiatives, particularly those designed to drive expanded market penetration of Iridex’s unique non-incisional glaucoma therapy products.

According to the companies, Iridex product portfolio to benefit from Topcon’s distribution strength in Asia Pacific and key EMEA markets, joining Topcon’s broad offering of diagnostic and treatment products for glaucoma and retina customers.

Under terms of the agreement, Iridex acquires Topcon’s PASCAL product line, combining Iridex’ MicroPulse technology with Topcon’s PASCAL laser platform, resulting in a leading market share for retinal scanning laser products, plus greater scale to generate design, manufacturing and marketing efficiencies.

“We feel energized entering into this important alliance with Topcon that advances the strategic positions of both companies on multiple fronts,” David Bruce, CEO of Iridex, said in a statement. “Joining Topcon’s comprehensive distribution network throughout Asia Pacific and key EMEA regions will help Iridex to significantly expand the market penetration of our marquee non-incisional glaucoma therapy.”

According to the comapnies, the collaboration between them includes three primary agreements, including an exclusive distribution agreement, an asset purchase agreement and an equity funding agreement.

Under the terms of these agreements, Topcon will acquire exclusive distribution of Iridex laser systems, delivery devices and disposable probes to be sold through its strong networks in Asia Pacific and key EMEA regions. Concurrently, Iridex will add Topcon’s PASCAL systems to its U.S. direct sales and rest-of-world distribution network. Further, Iridex will acquire the design and manufacturing operation of Topcon’s PASCAL product line.

Topcon will purchase $10 million of Iridex common shares at a price of $6.18 per share. The net cash proceeds to Iridex of these transactions are expected to be approximately $19.5 million before offering expenses.

According to the companies, Topcon can further capitalize on its already-strong distribution network by adding Iridex’s retina product portfolio to enhance the breadth of its ophthalmic system offerings.

Bruce noted that the alliance will enable both companies to benefit from the enhanced scale achieved by consolidating the design, manufacturing and distribution of two leaders in scanning laser retinal treatment. The infusion of $19 million in additional capital will provide Iridex with resources to drive its multiyear growth programs.

“We sought this alliance with Iridex to achieve significant benefits to our operating and distribution efforts. As leaders and innovators in advancing the treatment options for eyesight threatening diseases, we recognize a great opportunity to bring our strengths together,” Fumio Ohue, managing executive officer of Topcon’s Eye Care Business, said in a statement. “We are excited to bring Iridex’s retina

 and glaucoma therapy products to our expansive customer base throughout Asia Pacific and key Europe, Middle East and Africa markets.”

Ohue noted that the alliance with Iridex is one of the major initiatives which Topcon will offer with its “Shared Care” program.

“We are confident that combining our new product design and development efforts will enhance our existing and future products in both retina and glaucoma,” Ohue said. 

“In line with our goal of ensuring the long-term adoption of our laser-based MicroPulse TLT procedure in the marketplace, we are gratified with the high-level commitment Topcon has made to our platform, and we look forward to a strong partnership that is beneficial for patients and eye care specialists around the world for years to come,” Bruce concluded in a statement.

Articles

Topcon Corp. will purchase exclusive rights to distribute Iridex Corp.’s retina and glaucoma products, while also acquiring a common equity stake in the company.  Iridex will acquire Topcon’s PASCAL product line. 

Companies forge collaboration for glaucoma, retinal disease treatment


This article was reviewed by Raymond S. Douglas, MD, PhD

Teprotumumab (Tepezza; Horizon Therapeutics plc), a drug evaluated in the phase 3 OPTIC trial,

 was found to be efficacious over the long term for treating thyroid eye disease (TED), according to Raymond S. Douglas, MD, PhD.

The drug, a fully human monoclonal antibody inhibitor of IGF1, reduces inflammation and reverses retro-orbital tissue expansion and hyaluronan production by both binding to the IGF1 receptor/thyroid-stimulating hormone receptor–signaling complex and stopping the signaling at the source of the TED.

Thyroid eye disease: Not limited to visual impairment

Douglas is a professor of ophthalmology and director of the Orbit and Thyroid Eye Disease Center at Cedars-Sinai in Los Angeles California.



The 24-week OPTIC trial was a randomized, placebo-controlled trial of teprotumumab that randomly assigned 41 patients with active TED to infusions of the active treatment every 3 weeks (total of 8 infusions) and 42 patients to placebo infusions administered with the same frequencies. 

Patients were followed during the 24-week treatment period; the primary end point was a 2-mm or greater improvement in proptosis at the end of the treatment period. Patients then were followed during an off-treatment period, Douglas said.

The drug met the primary end point, with 82.9% of patients achieving a significant decrease in proptosis, and all secondary end points, such as improved inflammation, diplopia, and quality of life (

The investigators then sought to determine if the beneficial results were maintained over the long term. The 34 patients who responded to teprotumumab were evaluated during the off-treatment follow-up period.

“Maintained responders” were defined as those patients who continued to meet the 24-week response definition and received no additional TED treatment at the time of the 72-week visit, Douglas explained. This continued during the study.

“We found that 56% of patients who were responders at week 24 were still responders at week 72,” he said.

Douglas also explained that the 15 patients who did not meet the definition of a maintained responder at week 72 fell into one of the following categories: discontinued the study prematurely (n = 4); worsened slightly but not enough to qualify for the open-label, extension study OPTIC-X (n = 2); or qualified for OPTIC-X because of flare before the 72-week time point (n = 9).

At the final follow-up evaluation, 73% had an improvement in proptosis.


The patients who did not have an initial response to teprotumumab with reduced proptosis had the option of enrolling in the OPTIC-X study and undergoing another 8 infusions of teprotumumab and evaluation at 24 weeks.

Douglas reported that during the second course of the drug, 62.5% (n = 8 for whom data were available) of patients responded and had marked reductions in proptosis (–1.9 mm at 24 weeks).

The overall decrease in proptosis from the OPTIC baseline was significant (–3.3 mm at week 24 of the OPTIC-X study).

This result prompted the investigators to determine if nonresponders can benefit from more infusions of teprotumumab.

As COVID-19 focuses attention on vaccine, medication shortages loom

Specifically, the 5 nonresponders in the OPTIC study went on to receive the drug again in the OPTIC-X study. 

At week 24 of the OPTIC-X study, 2 were responders, 1 was a nonresponder, and 2 were not measured and therefore considered nonresponders. The results for these 5 patients demonstrated the residual benefit from a second treatment course.


The investigators wanted to know if a longer disease duration impacted the response to teprotumumab. 

Thirty-six patients randomly assigned to placebo were nonresponders and eligible for enrollment in OPTIC-X for a course of active drug; these patients were approximately 1 year out from the point at which TED was diagnosed (compared with a TED diagnosis of approximately 6 months in those randomized to teprotumumab initially in the OPTIC study).

According to investigators, the study also examined the efficacy ad various points in treatment during the trial, and investigators said they were pleased with the results that they received.

When the efficacy was evaluated at 24 weeks, Douglas reported that the proptosis response was almost identical to that in the OPTIC study—in that 89.2% of patients who were initially randomized to placebo and went on to active treatment had a proptosis response.


The rates of improvement of diplopia in the 2 groups also were similar: 67.9% in the teprotumumab arm of the OPTIC study and 60.9% in the placebo-to- teprotumumab group in the OPTIC-X study.

The trend also carried through the efficacy of the candidate, according to investigators.

The safety of teprotumumab in the phase 3 study was the same as in the phase 2 study; one patient had a serious adverse event during the second treatment course that was unrelated to active treatment.

Considering use of teprotumumab in thyroid eye disease patients


Douglas concluded that most of the patients who responded to active treatment at week 24 of the phase 3 study were still responders at week 72 without receiving any additional TED treatment.

“No new safety signals were identified. Regarding the patients who did not respond to teprotumumab during the OPTIC study, many had improvements in proptosis during the OPTIC-X study, with a similar safety profile,” Douglas pointed out. “OPTIC-X data provided evidence that supported the use of teprotumumab in patients who had had TED for a longer time than that studied in the phase 2 and 3 clinical trials.” 

Douglas is a consultant for Horizon Therapeutics.

1. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active thyroid eye disease. 

. 2020;382(4):341-352. doi:10.1056/NEJMoa1910434

Patients show impressive proptosis and diplopia responses to teprotumumab.

A new tool to treat TED

Cheryl Guttman is a medical writer based in Deerfield, Ill.


This article was reviewed by Geeta Lalwani, MD

Results from a study analyzing data from real-world patients with diabetes provided further evidence that the risk of both 

 (DME) development increase with higher DR severity.

Investigators also identified the existence of 3 distinct clinical subtypes among eyes with DR comprising a group at increased risk of clinically significant macular edema (CSME), a second group at increased risk of proliferative DR (PDR), and a third, smaller group at increased risk of developing both CSME and PDR within the same observation period of 5 years. 




The same pattern of 3 distinct progression subtypes was present in the overall population, as well as in the subsets by DR severity.

Geeta Lalwani, MD, of Rocky Mountain Retina Associates in Boulder, Colorado, presented the findings at the American Academy of Ophthalmology’s 2020 virtual annual meeting.

“In addition to DR severity, diabetes duration, hyperglycemia, hyperlipidemia, and hypertension are major drivers of DR progression,” Lalwani said. “However, these factors account for only about 10% of the risk of DR progression, which points to the potential involvement of other risk factors.”

Lalwani said the finding of different clinical subtypes among eyes with DR suggests that PDR and DME may represent 2 distinct disease processes driven by distinct genetic factors.

“Several candidate genes have been associated with DR pathogenesis, including those associated with angiogenesis and inflammatory pathways, and these appear to result in different phenotypes,” she said. “More research is needed on the clinical and genetic factors responsible for these distinct risks of DME versus PDR development in patients with type 2 diabetes.”

The study was conducted by reviewing clinical data and DR severity grades obtained from the assessments of 7-field color fundus photograph images collected between 1999 and 2016 in the Inoveon database of patients with diabetes who participated in a retina screening program at primary clinical centers.

Eligible patients selected for the current analyses had at least 2 gradable images in either eye from 2 different time points. 

The severity of DR, graded using the Early Treatment Diabetic Retinopathy Study, Diabetic Retinopathy Severity Scale (DRSS), and presence of CSME, was assessed by professional graders at a centralized reading center.

Aflibercept broadly effective for reducing DR severity in post-hoc analysis

The analyses included approximately 42,000 eyes of 22,000 patients. The patients were predominantly male (83%) and had type 2 diabetes (94%). Nearly 50% of the population was white, and Native Americans comprised 41% of the group.


A Kaplan-Meier analysis of data from the entire population showed that 2.7% of eyes developed at least 2-step worsening of DRSS by year 2, and the rate increased to just under 10% by year 5.

“Consistent with previous literature showing that baseline DR severity is an important predictor of DR progression, we found distinctly higher proportions of patients with higher DR severity at baseline developed an at least 2-step worsening over time,” Lalwani said.

At year 2, the rates of at least 2-step DR progression were 3.1% among eyes with mild nonproliferative DR (NPDR) at baseline and 8.4% to 12.9% for those with moderate to severe NPDR. 

At 5 years, more than 35% of eyes with moderate to severe NPDR at baseline experienced DR worsening.



dentifying biomarkers to predict diabetic retinopathy progression

Analyses of time to the first development of CSME and/or PDR showed more eyes developed either CSME or PDR alone versus both together. 

By year 5, the risk of developing CSME alone was 1.24%, the risk of developing PDR was just under 0.5%, and the risk of developing both CSME and PDR was 0.1% in the overall diabetes population.

The trend for distinct clinical progression subtypes was also observed in an analysis focused on subsets of eyes by DR severity at baseline, suggesting that factors other than DR severity at baseline are responsible for the distinct progression patterns.

Despite the similar pattern of clinical subtype progression, as expected, the overall rates of CSME and PDR development were much greater in the eyes with moderate to severe NPDR (DR severity levels 43, 47, and 53) than in the overall population.

By year 4, the risk of developing CSME alone was 18.7% in this group, and the risk of developing PDR alone was 10%, although both CSME and PDR developed in 2.5% of patients. 



Investigators see link between inflammation, diabetic retinopathy

The additional analysis investigating the moderately severe and severe NPDR (DR severity levels 47 and 53) subset also found the same pattern of clinical progression subtypes in the overall diabetes population, with patients developing either CSME or PDR alone, and relatively few developing both PDR and CSME.

As expected, this subset of patients with moderately severe and severe NPDR had the highest risk of progression; however, 28.7% progressed to CSME alone, 19.8% progressed to PDR alone, and 6.6% developed both CSME and PDR within the same observation period of 4 years.

“Interestingly, these trends were also observed in the sham arm of the PANORAMA study (NCT02718326), where after a shorter 100-week follow-up (approximately 2 years), the majority of patients developed vision-threatening complications of PDR/anterior segment neovascularization or center-involved DME alone, but not both events simultaneously,” Lalwani said.

Lalwani observed that because of its nature, the Inoveon study had several limitations, including heterogeneous screening frequencies.

Ocular gene therapy offers hope for inherited retinal disease

Lalwani mentioned that results of a retrospective cross-sectional study found that the majority of eyes with newly diagnosed PDR did not have concurrent DME, and the majority of eyes with newly diagnosed DME did not have concurrent PDR.

 

In addition, Hobbs et al reported that several systemic risk factors, including sex, age, type of diabetes, glycated hemoglobin level, blood pressure, and low-density lipoprotein cholesterol control, had no significant effect on the development of DME in eyes with PDR.

“These findings also suggest that PDR and DME may present 2 distinct disease processes potentially driven by distinct genetic risk factors,” Lalwani concluded. “Further research, focusing on the clinical and genetic factors responsible for distinct risks of DME versus PDR development in patients with type 2 diabetes is warranted.” 


Lalwani has no relevant financial interests to disclose.


1. Nwanyanwu KH, Talwar N, Gardner TW, Wrobel JS, Herman WH, Stein JD. Predicting development of proliferative diabetic retinopathy. 

. 2013;36(6):1562-1568. Wykoff CC. Retinal nonperfusion (RNP) extent and its relationship with visual, anatomic and disease state outcomes among eyes treated for diabetic macular edema. Presented at: Association for Research in Vision and Ophthalmology 2019 Annual Meeting.

2. Hobbs S, Mehta A, Patel A, Das A. Proliferative diabetic retinopathy and diabetic macular edema: are these two different disease processes? A retrospective cross-sectional study.

Baseline diabetic retinopathy severity is an important predictor of its progression in patients.

Investigators find genetic factors may influence diabetic eye disease

Oyster Point Pharma, Inc. announced today that the U.S. FDA accepted its New Drug Application (NDA) for its OC-01 (varenicline) nasal spray to treat dry eye disease (DED).

The OC-01 nasal spray is a highly selective cholinergic agonist that is administered as a preservative-free, aqueous nasal spray taken in multiple doses. It targets the parasympathetic nervous system that controls tear film homeostasis partially by way of the trigeminal nerve — accessible within the nose.

The company’s latest submission follows safety and efficacy results from its Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials,

. The trials included more than 1,000 participants with mild, moderate, or severe symptoms of DED.

Results showed OC-01 nasal spray demonstrated statistically significant improvements, as compared to control, in Schirmer’s Score, which was the primary endpoint in all trials, according to the release. Further, key secondary endpoints in the ONSET-1 and ONSET-2 included a shift from baseline in symptoms as assessed by eye dryness score.

In both trials, a statistically or nominally statically significant improvement in symptom scores at Day 28, and in the ONSET-2 trial as early as Day 14, in patients treated with the OC-01 nasal spray as compared to control, the release stated.

No serious drug-related events were reported in the clinical trial program.

The company’s Prescription Drug User Fee Act (PDUFA) target action for the nasal spray is October 17, 2021, according to a news release. At present, the FDA is not planning on holding an advisory committee meeting regarding the application.

1. Oyster Point Pharma. Pipeline: OC-01. Available at: 

https://oysterpointrx.com/pipeline/oc-01/

2. Oyster Point Pharma announces FDA acceptance for filing new Drug Application for OC-01(varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. Global News Wire. Available at: 

https://www.globenewswire.com/news-release/2021/03/02/2185010/0/en/Oyster-Point-Pharma-Announces-FDA-Acceptance-for-Filing-New-Drug-Application-for-OC-01-varenicline-Nasal-Spray-for-the-Treatment-of-Signs-and-Symptoms-of-Dry-Eye-Disease.html

The FDA has accepted Oyster Point Pharma's New Drug Application (NDA) for its OC-01 (varenicline) nasal spray to treat dry eye disease.









Oyster Point Pharma receives FDA filing acceptance of NDA for OC-01 nasal spray to treat DED

The field of ophthalmology is full of interesting people who leave a lasting impression on everyone they meet. For many, George Marcellino was such a person.

Beyond the many innovations he brought to fruition that will have a lasting impact on ophthalmology for years to come, Marcellino’s quick smile and compassionate heart will be an important part of his lasting legacy. 

Marcellino, who became Iridex's vice president in 2017 after serving on its board of directors for 3 years, passed away unexpectedly on February 10, 2021.

Paul Chew, MD, an eye surgeon and professor at the National University of Singapore, remembered his colleague as a leader in the field of ophthalmology.

“It is my privilege to say that I worked with George on laser innovation and our paths crossed over the past two decades repeatedly,” he recalled. “The meetings were always pleasant, encouraging and reassuring. It made me have faith that there was a man of sense and substance in the ophthalmic laser industry.”

Chew recounted that as he discussed potential laser developments with Marcellino, he was always open minded, receptive to ideas and contributed back equally.

“His example encouraged me to go on to develop the MP3 laser therapy,” Chew said. “Later, when George joined Iridex, he worked to make a better MP3 Generation 2 device that made the therapy the way it should have been in the first place.”

Chew noted that Marcellino was always innovating. In fact, the last email that he received from his friend just days before he passed away focused on yet another idea that he was making into reality.

“He was clearly brilliant all through his life and I will miss his maturity, comfort and counsel sorely,” Chew said. “George uplifted the well-being of humanity with his work.”

Prior to joining Iridex, Marcellino co-founded OptiMedica Corp. There he led the development of PASCAL (pattern scanning laser photocoagulation) for the treatment of retinal disease and also the development of the CATALYS femtosecond laser cataract system subsequently acquired by Abbott Laboratories in 2013.

He then held the position of senior vice president of clinical affairs and general manager for Kedalion Therapeutics, a start-up dedicated to the development of semi-automated topical ocular drug delivery as an alternative to standard eye drop delivery.

Prior to co-founding OptiMedica, Marcellino held several senior management positions at the Medical Group of Coherent, Inc. where he served as director of the global sales and marketing organizations reporting to the division head and led the clinical applications research and market development efforts.

Marcellino is widely known in the medical community, having more than 35 years of experience in the medical device industry including high technology devices for sensory and motor impaired persons (Telesensory Systems), critical care monitoring utilizing reflection spectrophotometry imbedded within a pulmonary artery catheter (Oximetrix), KTP laser surgical applications including the development of laser cholecystectomy (Laserscope), and ophthalmic, surgical and dermatologic laser applications (Coherent).

Born April 28, 1949, in Brooklyn, New York, Marcellino graduated from City University of New York with BA, MS and PhD in sensory physiology and psychophysics. He moved to California in 1978 to begin a career that focused on solving unmet medical needs.

In the field of ophthalmology, he helped establish a number of products, including the Novus 2000 Photocoagulator, the Laser Indirect Ophthalmoscope System, the Selecta Selective Laser Trabeculoplasty system for Primary Open Angle Glaucoma, the OPAL Photoactivator (Photodynamic Therapy) for age-related macular degeneration, Selective Retinal Therapy for the treatment of diabetic retinopathy, the CATALYS femtosecond laser for cataract surgery, and Iridex's revised MicroPulse P3 Delivery Device for the treatment of glaucoma.
Marcellino also co-authored 31 peer-reviewed articles in ophthalmic journals, two textbook chapters, and was co-inventor on nine patents.

The George R. Marcellino, PhD, Memorial Fund has been established at the Glaucoma Research Foundation, where he served on the Research Committee. Donations may be made in Marcellino’s memory to the Glaucoma Research Foundation at 

George Marcellino, vice president of Iridex, is being remembered by colleagues as a man of substance. 

George Marcellino remembered as innovator


This article was reviewed by Bennie H. Jeng, MD

There is a place for the use of autologous serum and blood products in the treatment of dry eye disease, and access to these products is improving. However, investigators must first address a few unanswered questions.

This treatment approach has been around for some time but was not popularized until 1999, when Tsubota et al

 reported that the growth factors and vitamins in the autologous serum eye drops made them beneficial.

“Since that time, there has been a great deal of interest in using autologous eye drops to treat various conditions of the ocular surface,” said Bennie H. Jeng, MD, professor of ophthalmology and chair of the Department of Ophthalmology and Visual Sciences at the University of Maryland School of Medicine in Baltimore.

 with autologous serum tears is an area of interest. The disorder is associated with diseases such as Sjögren syndrome, chronic graft- vs-host disease, Stevens-Johnson syndrome, and postkeratorefractive surgery.

A retrospective study showed that fluorescein staining improved in almost 75% of eyes after use of 20% autologous serum and improved subjective symptoms.

Another retrospective study that evaluated 50% autologous serum also showed improved fluorescein staining, Shirmer, and ocular surface disease index (OSDI) scores.

 

A more recent study of 100% autologous serum used to treat severe chronic ocular graft-vs-host disease found no issues with immune complex accumulation and ocular surface inflammation.

A prospective study that compared 20% autologous serum with preservative-free artificial tears showed that at the 1-month evaluation, the eyes treated with autologous serum had significantly longer tear film breakup time (TBUT) and a greater decrease in the OSDI scores, but the Schirmer scores and Oxford conjunctival and corneal vital dye grading scores did not differ between the 2 treatments, Jeng recounted.

Glaucoma and dry eye present double trouble for patients, ophthalmologists

To date, only 5 randomly assigned controlled studies (92 patients total) were included in a Cochrane review

 that evaluated autologous serum drops to treat 

“This study found that there may be some benefit to using autologous serum, but the available evidence was not definitive, and further studies are needed,” he reported.

A 2019 report by the American Academy of Ophthalmology

 agreed that autologous serum drops likely provide some benefit for patients with severe 

, but the lack of clinical trials precludes a more definitive role for this therapy.


The studies performed so far appear to show positive results for the use of autologous serum drops for patients with

, more work must be done before definitive results are reached.

Jeng pointed out areas to be studied, including the best way to process serum, which includes a determination of centrifugation time/speed and clotting time, the serum factors that are most beneficial; and optimal serum concentration.

Examining ocular allergy, quality of life

In addition to the benefits of the serum, harmful effects must be ruled out. 

A prospective cross-sectional study

 found that patients with primary Sjögren syndrome treated with autologous serum had significant improvement in ocular symptoms, ocular surface staining, and TBUT, but patients with secondary Sjögren syndrome had no improvement, likely because of the higher serum proinflammatory cytokine levels in those patients, which inhibited a benefit.

Complications such as immunoglobulin deposition, microbial contamination, and viral transmission to processing technicians, cost, and regulatory and legislative restrictions must be considered, Jeng said.


These have changed over time, in that little more than a decade ago, autologous serum tears were recommended for use in severe 

 cases. 

In contrast, the Dry Eye Workshop Study II elevated the use of autologous serum tears to step 3 from the previously recommended last treatment step.

Myths and misconceptions about autologous serum for dry eye

Other blood products in addition to autologous and allogeneic serum are umbilical cord serum and plasma products that include platelet releasate, plasma rich in growth factors, platelet-rich plasma, and fresh frozen plasma. 

These have had, in various studies, positive effects in the treatment of 

The future directions in this area of research include establishing a standardized protocol to manufacture autologous/allogeneic serum eye drops with more consistency and designing large high-quality randomized clinical trials to determine objective markers of success.

“However, even now, I can say that autologous serum and blood products have a role in treating dry eye and access to these products is improving. However, more investigations are needed into the components in the serum to determine which are the most efficacious,” Jeng concluded. 



1. Tsubota K, Goto E, Shimmura S, Shimazaki J. Treatment of persistent corneal epithelial defect by autologous serum application. 

. 1999;106(10):1984–1989. doi:10.1016/S0161-6420(99)90412-8

2. Lee GA, Chen SX. Autologous serum in the management of recalcitrant dry eye syndrome. 

. 2008;36(2):119-122. doi:10.1111/j.1442-9071.2008.01680.x

3. Hussain M, Shtein RM, Sugar A, et al. Long-term use of autologous serum 50% eye drops for the treatment of dry eye disease. 

. 2014;33(12):1245-1251. doi:10.1097/ICO.0000000000000271

4. Tahmaz V, Gehlsen U, Sauerbier L, et al. Treatment of severe chronic ocular graft-versus-host disease using 100% autologous serum eye drops from a sealed manufacturing system: a retrospective cohort study. 

 2017;101(3):322-326. doi:10.1136/bjophthalmol-2015-307666

5. Celebi ARC, Ulusoy C, Mirza GE. The efficacy of autologous serum eye drops for severe dry eye syndrome: a randomized double-blind crossover study. 

 2014;252(4);619-626. doi:10.1007/s00417-014-2599-1

7. Pan Q, Angelina A, Marrone M, Stark WJ, Akpek EK. Autologous serum eye drops for dry eye. 

. 2017;2(2):CD009327. doi:10.1002/14651858.CD009327.pub3

8. Shtein RM, Shen JF, Kuo AN, Hammersmith KM, Li JY, Weikert MP. Autologous serum-based eye drops for treatment of ocular surface disease: a report by the American Academy of Ophthalmology. 

. 2020;127(1):128-133. doi:10.1016/j.ophtha.2019.08.018

Autologous serum eye drops and blood products offer hope to patients. 


Investigators zoom in on future of dry eye treatment

This article was reviewed by Judy E. Kim, MD



Many imaging modalities are available for ophthalmologists to use in clinical care, but whether a specific technology is essential for individual clinicians depends on a variety of factors, according to Judy E. Kim, MD.

Kim, a professor of ophthalmology and director of teleophthalmology at the Medical College of Wisconsin in Milwaukee. 

She also offered her perspectives on how the features influence whether a particular device might be deemed a “need” versus a “want” for ophthalmologists in different practice situations.

“The discussion of determining whether anything is a need versus a want centers on 1 issue: Is it essential or just something that is desired or wished for,” she said. “However, the definition of essential is subjective and differs in different situations.”

Kim pointed out that with imaging devices, as in life, ophthalmologists have to prioritize their needs and wants.

“It can be a tricky balancing act that involves weighing what is necessary to provide best care for patients versus the cost, ease of use, accuracy, and the additional information provided by the device along with the needs of other clinicians in a practice, among many other considerations,” she explained.


The needs for imaging modalities vary between general ophthalmologists and different subspecialists. 

As a retina specialist, Kim said that if she had to choose just 1 imaging modality, it would be spectral domain (SD) OCT. SD OCT platforms generate high-resolution cross-sectional and 

 images of the retina, anterior segment, and optic nerve head.



OCTA a hope for diagnosing, managing ophthalmic diseases

This noninvasive imaging modality has revolutionized the diagnosis and management of retinal diseases by providing information that is often not readily visible on clinical evaluation.

Swept-source (SS) OCT is a newer technology that affords better imaging of the choroid and vitreous, improved imaging through blood and media opacity, and a wider field of view compared with SD-OCT.

However, Kim classified SS-OCT as a want rather than a need because of its cost and the fact that the information provided by SD-OCT currently suffices for patient management.


Ultrasound is not often used by retina specialists, but Kim still considered it a need because it allows visualization of the posterior segment when other imaging is not possible. 

As a result, it allows diagnosis of retinal detachment, intraocular foreign body, posterior scleritis, optic nerve head drusen, and other issues. 

It is also essential for ocular oncologists, who use it more often to differentiate various types of tumors and to monitor for tumor growth, but it may not be essential for general ophthalmologists, she said.

Although some ophthalmologists feel there is no longer a need for color fundus imaging, Kim said she still finds it useful for documentation and education. However, she is relying more on widefield and ultra-widefield systems that image between 50º and 200º field, respectively.



FAF shedding light on patterns related to disease chronicity in CSC

“Why limit ourselves to a small field of view when we can see so much more with widefield or ultra-widefield imaging,” she said, adding that being able to image a widefield with a single shot is useful for imaging children, who often cannot sit for long periods.

As a major benefit, ultra-widefield imaging allows documentation and evaluation of a multitude of retinal conditions that affect the periphery as well as the posterior pole.

Furthermore, whereas images acquired with conventional fundus cameras can be suboptimal in eyes with small or undilated pupils, systems that utilize confocal scanning laser ophthalmoscopy can photograph the peripheral retina in eyes with pupil diameters as small as 2.5 mm.

“Imaging through an undilated pupil may be especially useful for teleretinal screening and for allowing faster flow of patients in the clinic, which has become especially important during the [coronavirus disease 2019] pandemic,” Kim said.

“In addition, several studies have established the equivalence in sensitivity between nonmydriatic ultra-widefield scanning laser ophthalmoscopy images and dilated [Early Treatment Diabetic Retinopathy Study] standard 7-field stereo photographs for evaluating the severity of 

,” she said. “Being able to see [farther] out to the peripheral can improve staging and diagnosis.”



OCT: Illuminating the retina layer by layer

Kim said she considers ultra-widefield fundus fluorescein angiography (FA) to be another essential tool for managing patients with retinal vascular disease.

According to Kim, for most ophthalmologists, fundus autofluorescence (FAF) may be desirable but not essential.

She explained that FAF is a useful modality for assessing progression of geographic atrophy in patients with dry age-related macular degeneration and for studying and managing eyes with rare inherited retinal degenerative diseases. 

In addition, FAF is useful adjunctive imaging to SD-OCT as a screening tool for hydroxychloroquine toxicity because it can detect early as well as late stages of this condition.

“For Asian patients, widefield fundus autofluorescence may be useful given evidence that changes in the paracentral macula may be present early in the development of hydroxychloroquine toxicity within this racial group,” Kim noted.




OCT angiography (OCT-A) is another type of OCT that allows noninvasive visualization of retinal and choroidal vessels without the use of intravenous dye. It is ideal for patients who are allergic to fluorescein dye or who are pregnant. 

Compared with FA, evaluation of the foveal avascular zone and different layers of blood vessels are improved with OCT-A.

The fact there is no leakage of dye with OCT-A may make visualizing retinal neovascularization more difficult compared with conventional FA, and this newer technology is also hampered by variable image quality, smaller field of view, and difficulty in interpretation. 

Together these issues make OCT-A more of a want than a need, Kim said. “Of course, swept-source devices can provide an unparalleled field of view with OCT-A, but still cost is a deterrent,” she said.


“We now have many imaging options that allow us to visualize the retina [as] never before, and more innovations are expected in the future,” Kim said. “Each physician and the practice should evaluate which imaging modalities and what combination of these in a device will best serve the patients and the practice.” 

e: jekim@mcw.edu
This article is based on a presentation from the American Academy of Ophthalmology’s virtual 2020 annual meeting that provided an overview of the capabilities and limitations of a number of imaging modalities.


Kim receives research support from Optos.

Physicians should evaluate which options best meet the needs of their practices.

Do you 'need' or just 'want' that new diagnostic imaging device?

In recent years, intermittent shortages of Phospholine Iodide (echothiophate iodide) ophthalmic drops have created issues for ophthalmologists, and the American Academy of Ophthalmology, American Glaucoma Society and the American Association for Pediatric Ophthalmology and Strabismus have often stepped up to work with Pfizer to correct the issue.

Ultimately, an unstable supply chain proved to be too great of a hurdle, and Pfizer announced recently it will discontinue the drops. The medication is used to treat IOP in glaucoma patients and also is prescribed for other issues, such as accommodative esotropia. There is no generic equivalent available, and Pfizer is the only manufacturer. 

Citing an unstable supply chain, Pfizer is discontinuing the ophthalic drops. 

Do you 'need' or just 'want' that new diagnostic imaging device?

Drugmaker pulling the plug on Phospholine Iodide

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