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Clinical

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Ehsan Rahimy, MD, speaks on the highlights of a study he presented at this year's virtual AAO 2020 meeting that aimed to integrate an artificial intelligence screening system for managing diabetic retinopathy referrals in a primary care setting — with limited specialty support.

Integrating AI to manage DR in a primary care setting

Davinder Grover, MD, MPH, speaks on the highlights of his presentation regarding outcomes of a 12-year study comparing ab externo vs ab interno xen gel stents in tertiary glaucoma practice. 

AAO 2020: Comparing outcomes of xen gel stents in glaucoma practice

Novartis has announced positive topline results from the phase 3 KITE study of brolucizumab 6 mg versus aflibercept for patients with diabetic macular edema.  

Novartis: Positive DME data for brolucizumab in KITE trial

The FDA has granted the fourth Orphan Drug Designation for a novel gene therapy product candidate (OCU400, Ocugen Inc.) in the treatment of PDE6B gene mutation-associated retinal diseases.

FDA grants fourth ODD for treatment of PDE6B gene mutation-associated retinal diseases

A team of Turkish investigators detected COVID-19 viral material on the environmental surfaces of an ophthalmology examination room despite triage systems to exclude patients with the virus. 

Investigators: Asymptomatic COVID-19 patients may have left viral material on surfaces of ophthalmology exam room

Patient enrollment for the NORSE 2 clinical trial has been completed, with safety and efficacy data expected to be reported in the third quarter of 2021. 


Company seeks first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications

Retina World Congress 2025 will take place May 8-11. As researchers prepare for their, presentation, we are highlighting the upcoming sessions that are scheduled for this meeting, which will be held in Fort Lauderdale, Florida.

Note: The following list of presentations are in alphabetical order by company. Updates will be added to this article as new information becomes available.

The company highlight Phase 2 results for migaldendranib (MGB), Ashvattha’s investigational subcutaneous treatment for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The presentation, entitled, "Emerging Data om Anti-angiogenic Nanomedicine (Migaldendranib MGB/D-4517.2) for AMD and DME" will be given by Michael Singer, MD on Sunday, May 11, 2025; 11:11 – 11:16 am ET.

Phase 2 clinical data demonstrated that MGB administration lowered production of subretinal fluid reducing or eliminating the need for intravitreal anti-VEGF treatment in both the study eye and fellow eye in wet AMD and DME subjects with bilateral disease. New data indicates that MGB may be the first safe systemic therapy for the treatment of wet AMD and DME without ocular adverse events.

Huma Qamar, Chief Medical Officer at Ocugen will represent Ocugen at Retina World Congress to share a presentation and join retinal surgeons and industry peers during a panel discussion.

Inherited and Rare Retinal Diseases Session
Moderated by Rishi P. Singh, MD, FASRS and Kourous A. Rezaei, MD on Thursday, May 8, 2025, 10:35 – 11:12 AM ET

Ocular Therapeutix will present information at the meeting in Fort Lauderdale regarding the axitinib intravitreal hydrogel clinical trials, the use of its candidate OTX-TKI for diabetic retinopathy, and the HELIOS clinical trial for diabetic retinopathy.

Axitinib Intravitreal Hydrogel: Update on Clinical Trials

Presented by Carl C. Awh, MD, FASRS, on Friday, May 9, 2025, 4:33 – 4:38 PM ET.

Presented by Dilsher S. Dhoot, MD, FASRS on Saturday, May 10, 2025, 8:44 – 8:49 AM ET

Volumetric Macular Fluid Analysis of the Impact of a Single Axitinib Intravitreal Injection (OTX-TKI) from the HELIOS Clinical Trial for Diabetic Retinopathy

Presented by Carl J. Danzig, MD on Saturday, May 10, 2025, 8:52 – 8:57 AM ET

The company will present further insights from Stage 1 of the Phase 3 DIAMOND program reinforcing the efficacy and safety profile of OCS-01 eye drops for DME will also be shared. OCS-01 is being developed to be the first non-invasive treatment for DME, addressing key unmet needs for earlier treatment intervention and for inadequate responders to the current standard of care.

Ashvattha Therapeutics to Present at ARVO, Retina World Congress, and AOS Annual Meeting. Ashvattha Therapeutics. April 15, 2025. Accessed April 16, 2025. https://www.globenewswire.com/news-release/2025/04/15/3061682/0/en/Ashvattha-Therapeutics-to-Present-at-ARVO-Retina-World-Congress-and-AOS-Annual-Meeting.html

Ocugen to Present on Modifier Gene Therapy Platform at Association for Research in Vision and Ophthalmology 2025 Annual Meeting and Retina World Congress. Ocugen Inc. April 29, 2025. Accessed April 30, 2025. https://www.globenewswire.com/news-release/2025/04/29/3070074/0/en/Ocugen-to-Present-on-Modifier-Gene-Therapy-Platform-at-Association-for-Research-in-Vision-and-Ophthalmology-2025-Annual-Meeting-and-Retina-World-Congress.html

Ocular Therapeutix™ to Participate in Upcoming Investor and Scientific Conferences. Ocular Therapeutix. April 29, 2025. Accessed April 29, 2025. https://www.globenewswire.com/news-release/2025/04/29/3070022/0/en/Ocular-Therapeutix-to-Participate-in-Upcoming-Investor-and-Scientific-Conferences.html

Oculis to Present its Innovative Late-Stage Pipeline Candidates at Upcoming Ophthalmology Conferences. Oculis Holding AG. May 1, 2025. Accessed May 1, 2025. https://www.biospace.com/press-releases/oculis-to-present-its-innovative-late-stage-pipeline-candidates-at-upcoming-ophthalmology-conferences

Companies working in the retina space have announced that data from clinical trials will be shared at this year’s meeting in Fort Lauderdale, Florida.

RWC 2025: Companies to share data at meeting in Fort Lauderdale

jCyte recently announced the dosing of the first patients enrolled in the JC02-88 study for the evaluation of famzeretcel (jCell; jCyte) for the treatment of retinitis pigmentosa (RP).

 Famzeretcel consists of allogeneic retinal progenitor cells (RPCs) administered via intravitreal injection.

“The initiation of the patient dosing in this trial marks an important milestone in our mission to bring a breakthrough treatment to the majority of RP patients who currently have limited treatment options,” John Sholar, CEO of jCyte, said in a press release.

JC02-88 is a phase 2 trial evaluating the safety, tolerability, and efficacy of a single 8.8 million cell injection of famzeretcel. The famzeretcel dose being studied in the JC02-88 study is approximately 50% higher than the highest dose administered in previous jCyte clinical trials.

 Patients enrolled will receive either 1 famzeretcel dose or a sham treatment (control) and will be assessed for safety and vision changes over 6 months.

The trial is supported by the Gavin Herbert Eye Institute, the UCI GMP Facility, Lexitas, and the California Institute for Regenerative Medicine. A subsequent extension study is anticipated following the conclusion of the JC02-88 trial.

A couple of basics are needed to achieve a response to famzeretcel, 

 Based on the neurotrophic mechanism of famzeretcel, it was hypothesized in a phase 2b study that patients with RP need to have sufficient living photoreceptors to enable restoration of visual function.

 Photoreceptors cannot divide and replace dead adjacent photoreceptors. To benefit from neurotrophic factors, a photoreceptor may have lost its function but must still be alive. More specifically, sufficient living cone photoreceptors are needed to achieve a BCVA response to the famzeretcel injection.

Affecting an estimated 2 million people worldwide, with 100,000 in the United States, RP is a rare genetic disorder that leads to progressive loss of the rod and cone photoreceptors in the retina. Typically diagnosed in adolescence, it causes many patients to become legally blind by middle age.

“This is an exciting development for the RP community, and I am eager to see how this promising therapy advances toward providing a novel cell-therapy treatment for a patient population with vast unmet need,” Paul Sieving, MD, PhD, Neil and MJ Kelly Professor of Ophthalmology at UC Davis School of Medicine and immediate past director of the National Eye Institute at NIH, said in a press release.

jCyte Inc. Announces First Patients Treated in JC02-88 Trial for Retinitis Pigmentosa. August 18, 2025. Accessed August 18, 2025. 

https://www.businesswire.com/news/home/20250818947550/en/jCyte-Inc.-Announces-First-Patients-Treated-in-JC02-88-Trial-for-Retinitis-Pigmentosa

Charters L. Retinal progenitor cells: Targeting retinitis pigmentosa. 

https://www.ophthalmologytimes.com/view/retinal-progenitor-cells-targeting-retinitis-pigmentosa

jCyte initiates patient dosing in a new trial for famzeretcel, aiming to transform treatment options for retinitis pigmentosa.

Canonical

clinical

First patients dosed in JC02-88 study

German researchers described a rare case of tubulointerstitial nephritis and uveitis (TINU) syndrome in a teenager,

 the management of which requires a multidisciplinary approach.

TINU is a rare autoimmune disorder that affects the kidneys and eyes concurrently; the most common presentation in the eyes is bilateral, nongranulomatous anterior 

 TINU predominantly affects adolescents and young adults, with a median onset time around 14 to 15 years of age,

 according to Markus Kerner, MD, a general practitioner in Neuffen, Germany, and colleagues.

The clinical presentation is heterogeneous and often nonspecific.

 Renal manifestations may include fatigue, flank discomfort, polyuria, or signs of acute kidney injury

; ocular symptoms are bilateral anterior uveitis with pain, photophobia, or visual disturbances.

 However, some patients can be asymptomatic, and uveitis may be discovered incidentally on ophthalmologic examination,

Renal and ocular symptoms can occur simultaneously or sequentially, which may delay diagnosis.

 Uveitis frequently persists or can relapse.

They described the case of a 15-year-old girl who presented to her general practitioner with complaints of fatigue and polyuria. She also reported a recent intentional weight loss. The onset of TINU occurred after she started treatment with sertraline for depression, suggesting a possible drug trigger.

Evaluation revealed acute kidney injury with elevated serum creatinine and a tubular pattern of proteinuria, mild anemia, elevated ferritin levels, and abnormal urinalysis with proteinuria, glucosuria, hematuria, and microalbuminuria; the patient was admitted to a pediatric hospital. A renal biopsy confirmed acute, nongranulomatous tubulointerstitial nephritis. An ophthalmologic examination revealed bilateral anterior uveitis, confirming the TINU syndrome diagnosis.

Regarding ocular involvement, Kerner and colleagues noted that while the patient had no ocular complaints at presentation, the ocular involvement was not clinically apparent. This agreed with previous reports that the uveitis can be mild, bilateral, and asymptomatic, underscoring the importance of proactive ophthalmologic assessment in patients with unexplained interstitial nephritis.

 “The temporally dissociated onset of renal and ocular findings remains one of the principal challenges in TINU diagnosis,"

Treatment included high-dose oral steroids that resulted in recovery of renal function and general well-being. The patient was followed by pediatric nephrology and ophthalmology.

Kerner and colleagues also noted, “Long-term outcomes in TINU syndrome are generally favorable when the condition is identified early and managed appropriately. Nevertheless, uveitis tends to relapse more frequently than nephritis and may persist or reappear months to years after the initial episode.

 Regular follow-up with both pediatric nephrology and ophthalmology remains essential.”

They concluded, “This case illustrates how clinical vigilance in primary care can facilitate the early recognition of TINU syndrome in an adolescent presenting with nonspecific systemic and renal symptoms.”

Kerner M, Todoroff J, Von Schnakenburg C, Amann K, Müller-Kühnle J. Fatigue, polyuria, and hidden uveitis: a case of tubulointerstitial nephritis and uveitis syndrome diagnosed in primary care. 

 12025;7: e89245. doi:10.7759/cureus.89245

Bograd A, Heiligenhaus A, Reuter S, Tappeiner C. 

A comprehensive review of tubulointerstitial nephritis and uveitis (TINU) syndrome

The syndrome of tubulointerstitial nephritis with uveitis (TINU)

Sanchez-Quiros J, Giralt L, Fonollosa A, Robles I, Carreño E. 

Diagnostic and management strategies of tubulointerstitial nephritis and uveitis syndrome (TINU): current perspectives

Matsumoto K, Fukunari K, Ikeda Y, et al. 

A report of an adult case of tubulointerstitial nephritis and uveitis (TINU) syndrome, with a review of 102 Japanese cases

The tubulointerstitial nephritis and uveitis syndrome

Tubulointerstitial nephritis and uveitis syndrome: case report and review of the literature

Course and outcome of tubulointerstitial nephritis and uveitis syndrome

Tubulointerstitial nephritis and uveitis syndrome

Classification criteria for tubulointerstitial nephritis with uveitis syndrome

Amaro D, Carreño E, Steeples LR, Oliveira-Ramos F, Marques-Neves C, Leal I. 

Tubulointerstitial nephritis and uveitis (TINU) syndrome: a review

Paroli MP, Cappiello D, Staccini D, Caccavale R, Paroli M. 

Tubulointerstitial nephritis and uveitis syndrome (TINU): a case series in a tertiary care uveitis setting

Tubulointerstitial nephritis and uveitis syndrome: characterization of clinical features

Sobolewska B, Bayyoud T, Deuter C, Doycheva D, Zierhut M. 

Long-term follow-up of patients with tubulointerstitial nephritis and uveitis (TINU) syndrome

Khochtali S, Harzallah O, Hadhri R, Hamdi C, Zaouali S, Khairallah M. 

Neuroretinitis: a rare feature of tubulointerstitial nephritis and uveitis syndrome

A rare case of tubulointerstitial nephritis and uveitis syndrome in a teenager highlights the importance of multidisciplinary diagnosis and management.

Multidisciplinary insights into diagnosing tubulointerstitial nephritis, uveitis

An aging population combined with the increasing incidence of chronic disease has led to a steady rise in the number of patients requiring retinal care. 

Thankfully, modern diagnostic imaging and better access to health care have allowed us to catch disease earlier and intervene sooner. Such advances help us achieve better long-term outcomes for our patients, but they also add to the volume and complexity of care.

I practice in Asheville, North Carolina, a city with a large retired population. I manage a high volume of patients with retinal diseases, includ

ing age-related macular degeneration (AMD)

AMD represents approximately 80% of my clinical workload. Making sure these patients have a positive experience while they are in our care requires a fine balance of safety and efficiency. We achieve each element by establishing and following preinjection protocols and building trust with our patients. We believe in tailoring not only the procedure but also our anesthetic approach based on patient needs.

, intravitreal injections (IVIs) remain the gold standard of care. Anti-VEGF agents have revolutionized outcomes, helping preserve sight in millions of patients who would have otherwise lost significant vision. But the treatment comes with a catch: the burden of frequent and repeated injections.

On any given day, I may perform between 40 and 80 injections. That is not unusual in a busy retina practice. IVI schedules are overwhelming for our clinic, but also for our patients. Even those who have been through the process before may be anxious or worried before the injection. 

Particularly for those with bilateral disease, who sometimes require 2 different IVIs every month, there is a lot of associated emotional stress, transportation issues, and physical discomfort. As clinicians, we are always looking for ways to reduce the friction in this process. A smooth and efficient preinjection protocol not only ensures safe, effective, and consistent care but also may reduce patients’ stress and enhance their experience.

Discomfort during IVIs is one of the most common patient concerns. Although the injection only takes a few seconds, poor anesthesia or a rushed preinjection process may make those few seconds feel like a lifetime for a patient.

Over the years, I have explored myriad options to optimize anesthesia. Early in my practice, there were no FDA-approved anesthetics for IVIs. The standard approach was topical drops such as proparacaine and tetracaine, followed by povidone-iodine (Betadine) for antisepsis. Although fast and efficient, the method often left patients wincing in significant discomfort. More than occasionally, I found patients were reluctant to return for follow-up care and IVIs.

Viscous anesthetic gels offer better pain control. Products such as lidocaine hydrochloride ophthalmic gel (Akten; Théa Pharma) and tetracaine hydrochloride 0.5% ophthalmic gel (TetraVisc; OCuSOFT) help keep the anesthetic in place longer, allowing more effective numbing at the injection site. The trade-off, however, is that the thick gel may trap bacteria on the ocular surface, potentially increasing the risk of endophthalmitis.

 Additionally, prolonged exposure of the gel to the cornea, especially when clinic flow is delayed, can result in epithelial toxicity and delayed wound healing, which can lead to large corneal abrasions and days of discomfort.

Subconjunctival lidocaine provides the most complete pain relief but requires additional setup, an extra needle stick, and additional risk to the patient. This lengthens the preinjection process for our staff and reduces clinic efficiency. Even though the time difference may be only one minute per patient, the extra time in a long clinic day can add up to nearly an hour by the end of the day. Although patients feel less pain and discomfort during the injection, some experience anxiety around the numbing injection itself, and many have more prolonged discomfort when the anesthetic effect wears off.

chloroprocaine hydrochloride ophthalmic gel 3% (Iheezo; Harrow)

 and have incorporated it into my injection anesthetic routine. The preservative-free gel is formulated with a lubricating component and is the first FDA-approved ocular anesthetic gel in more than 10 years specifically labeled for ophthalmic use, including IVIs. 

I began using chloroprocaine hydrochloride ophthalmic gel because of its potential to offer more comfort than traditional drops while streamlining the process compared with subconjunctival injection.

 Findings from a phase 3 trial showed that 1 dose (3 drops) achieved sufficient ocular surface anesthesia in less than 90 seconds and lasted approximately 21.5 minutes.

 This is much easier than other protocols that involve the use of multiple drugs and application methods.

Chloroprocaine hydrochloride ophthalmic gel has an established safety profile comparable to other local ocular anesthetics.

 Additionally, it is 75% less viscous than other FDA-approved anesthetic gels (

) and has demonstrated no barrier to the bactericidal actions of povidone-iodine 5%.

In my hands, chloroprocaine ophthalmic gel is preferred to other anesthetic approaches because it is safe, easy to apply, remains localized at the site of administration, and provides consistent anesthesia for most patients. 

I appreciate that chloroprocaine hydrochloride ophthalmic gel is a single-use, sterile product, reducing concerns about cross-contamination from other patients as well as endophthalmitis rates compared with multiuse ophthalmic anesthetics. It also washes out quickly due to the lower viscosity, allowing patients to return to normal activity sooner. 

With that said, ophthalmic gel is not a perfect solution for everyone. There is a theoretical risk of surface toxicity, infection, and delayed wound healing.

 Although the data are not conclusive, it is a valid point of concern and underscores the importance of weighing the risks and benefits of anesthetic methods in each clinical context.

Balancing comfort, safety, and efficiency

Ultimately, every anesthetic approach comes with trade-offs:

 are fast and efficient but provide the least amount of comfort for patients.

 offers complete anesthesia but slows clinic flow.

 can strike a balance but may raise questions about surface toxicity or infection risk depending on the product and protocol.

In my practice, I tailor anesthesia to patient needs and the clinic day’s demands. For patients with high anxiety or those with a history of discomfort, I lean toward chloroprocaine ophthalmic gel with subconjunctival lidocaine. 

chloroprocaine hydrochloride ophthalmic gel

 has become the standard of care for me. It has significantly improved patient satisfaction and adherence without significantly affecting efficiency.

As we continue to manage the growing burden of retinal disease, helping to improve the patient’s quality of life and experience matters more than ever. Streamlining the injection process while prioritizing comfort is key to building trust and ensuring adherence over years of ongoing retinal care.

Vitreoretinal Surgeon, Carolina Ophthalmology, P.A., Asheville, North Carolina.

1. Lad EM, Maltenfort MG, Leng T. Effect of lidocaine gel anesthesia on endophthalmitis rates following intravitreal injection. 

. 2012;43(2):115-120. doi:10.3928/15428877-20120119-01

2. Stem MS, Rao P, Lee IJ, et al. Predictors of endophthalmitis after intravitreal injection: a multivariable analysis based on injection protocol and povidone iodine strength. 

. 2019;3(1):3-7. doi:10.1016/j.oret.2018.09.013

3. Miller DD, Wagner IV, Ten Hulzen RD, et al. Delayed corneal healing after the use of topical ophthalmic anesthetics. 

. 2024;16(9):e70455. doi:10.7759/cureus.70455

4. Iheezo. Prescribing information. Harrow IP LLC; 2022.

6. Chloroprocaine hydrochloride ophthalmic gel 3%. Pharmaceutical development. Sintetica; 2022.

7. Han J, Rinella NT, Chao DL. Anesthesia for intravitreal injection: a systematic review. 

. 2020;14:543-550. doi:10.2147/OPTH.S223530

8. Akten. Material safety data sheet. Akorn Pharmaceuticals; 2010.

9. Ilyas H, Costine R. The effects of low viscosity preservative-free chloroprocaine ophthalmic gel 3% versus BAK-containing tetracaine 0.5% on the bactericidal action of povidone-iodine. 

. 2024;18:825-831. doi:10.2147/OPTH.S454496

The role of anesthetics in streamlining efficiency and elevating patient care.

Improving patient experience with intravitreal injections

Now is an exciting time to be a retina specialist. A wave of innovations and regulatory approvals has emerged in the past year that has the potential to change our practice patterns. Although it can be difficult to keep up with what often seems like an endless font of presentations and publications, I would like to highlight a few recent developments that I think are particularly noteworthy.

Catch up on recent advancements in retina care, including new therapies for age-related macular degeneration and macular telangiectasia, enhancing patient outcomes.

David Hutton

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