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An implantable solution fills the treatment gap for AMD patients

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

A study performed by Indian researchers found that children with retinoblastoma were diagnosed after a lag time of under 3 months, which in turn delayed treatment. They cited the need for training and awareness initiatives to improve management of these patients,

 according to the first author, Sima Das, MD. She is from the Oculoplasty and Ocular Oncology Services, Dr Shroff’s Charity Eye Hospital, New Delhi, India.

Retinoblastoma is the most common intraocular malignant cancer in children, and survival rates depend on the geographic location and the economic status of the country. Das and colleagues cited a study that reported that the 3-year survival rate in low- and middle-income countries was 50%, in contrast to almost 100% survival in patients in high-income countries.

The survival rates reported from high-income countries were 88% in the United Kingdom and 93% in the US.

 However, in countries like India, Nepal, Africa, and South American countries, the children with retinoblastoma present much later when the disease is more advanced, and their prognoses are significantly inferior. For example, orbital retinoblastoma has been reported to be 18% in Mexico, 36% in Taiwan, and 40% in Nepal, and ranges from 9% to 45% in India, Das and colleagues related.

“Delay in diagnosis of retinoblastoma has been associated with lower chances of globe salvage and higher mortality.

 Studies from South America have noted prolonged time to diagnosis to be more associated with extraocular disease at presentation.

 Reduced lag time to diagnosis has been associated with less advanced RB, as found in a Swiss study.

 A large proportion of the delay in diagnosis has been attributed to delayed referral to specialists,"

Ocular salvage and preservation of vision are essentially dependent on early diagnosis, and several studies have been conducted to identify the factors leading to delayed diagnosis at presentation.

It remains unclear the degree to which prolonged lag time is attributable to delayed presentation by the family (parental lag time) as opposed to delays in the health care system (system lag time). This prospective, multicentric study of newly diagnosed retinoblastoma was undertaken to investigate lag time and its correlation with various variables.

The study extended over 3 years and included 1120 patients from 20 centers.

The investigators reported, “Extraocular or metastatic disease was present in 25.2% of patients at diagnosis. The mean lag time from symptom onset to treatment initiation was 4.2 months (range, 0.5-61.6 months). Parental, diagnosis, and treatment lag times contributed to 44%, 26%, and 31% of the total lag time, respectively.

Parental lag time was the chief culprit in the delayed diagnosis of retinoblastoma and treatment. “Increased lag time was significantly correlated with the stage at presentation (

 = .006), increased distance from treating center (

 = .001), younger maternal age at pregnancy (

 = .031), and first consultation with a nonspecialist (

 = .001), and was negatively correlated with improved maternal education.

Das and colleagues concluded, “Parental lag time is the major contributor to the cascading delay in retinoblastoma diagnosis and treatment initiation. Efforts for earlier diagnosis, therefore, need to be directed towards community awareness and routine screening during contact with health care professionals, such as at immunization. The first consultation with a nonspecialist other than an ophthalmologist or pediatrician was associated with delayed diagnosis. Hence, training and awareness initiatives should be directed towards all cadres of health care workers and not be limited to specialists.”

Das S, Meel R, Mahajan A, et al. Lag time for diagnosis and treatment in 1120 retinoblastoma children: Analysis from InPOG-RB-19-01

Fabian ID, Abdallah E, Abdullahi SU, et al. Global Retinoblastoma Study Group Global retinoblastoma presentation and analysis by national income level. 

Sanders BM, Draper GJ, Kingston JE. Retinoblastoma in Great Britain 1969–1980: incidence, treatment and survival. 

Abramson DH, Niksarli K, Ellsworth RM, Servodidio CA. Changing trends in the management of retinoblastoma 1951–1965 vs 1966–1980. 

Leal-Leal C, Flores-Rojo M, Medina-Sanson A, et al. A multi-centre report from the Mexican retinoblastoma group. 

Kao LY, Su WW, Lin YW. Retinoblastoma in Taiwan: Survival and clinical characteristics 1978–2000. 

Badhu B, Sah SP, Thakur SK, et al. Clinical presentation of retinoblastoma in Eastern Nepal. 

Kaliki S, Patel A, Iram S, Ramappa G, Mohamed A, Palkonda VAR. Retinoblastoma in India: clinical presentation and outcome in 1,457 patients (2,074 eyes). 

Hazarika M, Kumar G, Saikia BJ, et al. Clinicoepidemiological profile and treatment outcomes in children with retinoblastoma: Experience from a cancer care center in Northeast India. 

Singh U, Katoch D, Kaur S, Dogra MR, Bansal D, Kapoor R. Retinoblastoma: a sixteen-year review of the presentation, treatment, and outcome from a tertiary care institute in Northern India. 

Pant G, Verma N, Kumar A, Pooniya V, Gupta SK. Outcome of extraocular retinoblastoma in a resource limited center from low middle income country. 

Chawla B, Hasan F, Azad R, et al. Clinical presentation and survival of retinoblastoma in Indian children. 

Kaliki S, Ji X, Zou Y, et al. Lag time between onset of first symptom and treatment of retinoblastoma: An International collaborative study of 692 patients from 10 countries. 

Fabian ID, Stacey AW, Foster A, et al. Travel burden and clinical presentation of retinoblastoma: Analysis of 1024 patients from 43 African countries and 518 patients from 40 European countries. 

Chantada G, Fandino A, Manzitti J, Urrutia L, Schvartzman E. Late diagnosis of retinoblastoma in a developing country. 

Canturk S, Qaddoumi I, Khetan V, et al. Survival of retinoblastoma in less-developed countries impact of socioeconomic and health-related indicators. 

Wallach MBA, Munier F, Houghton S, Pampallona S, von der Weid N, Beck-Popovic M. Shorter time to diagnosis and improved stage at presentation in swiss patients with retinoblastoma treated from 1963 to 2004. 

Sethi S, Pushker N, Kashyap S, et al. Extraocular retinoblastoma in Indian children: clinical, imaging and histopathological features. 

Goddard AG, Kingston JE, Hungerford JL. Delay in diagnosis of retinoblastoma: risk factors and treatment outcome. B

Butros LJ, Abramson DH, Dunkel IJ. Delayed diagnosis of retinoblastoma: Analysis of degree, cause, and potential consequences. 

Canonical

clinical

Parental delay largely causes late retinoblastoma diagnosis, treatment

A recent exploratory analysis has found key predictive factors of improved best-corrected visual acuity (BCVA) a year and a half after patients with Leber hereditary optic neuropathy (LHON) (caused by mt-ND4) receive GenSight Biologics’ investigational gene therapy lenadogene nolparvovec (Lumevoq) at least 6 months after disease onset.

Better BCVA values and baseline thicker ganglion cell layer (GCL) and retinal nerve fiber layer (RNFL) at optical coherence tomography (OCT) measurements were found to be the key factors. The analysis was published in 

Investigational Ophthalmology and Visual Science.

Linking structure and function "improves our understanding of the factors influencing vision recovery after lenadogene nolparvovec administration in patients with MT

ND4 LHON, showing that better baseline BCVA values and thicker baseline OCT retinal layers in the dynamic phase of the disease, particularly the outer segments of macular GCL, are the key predictive factors associated with better BCVA 1.5 years after treatment in patients who received gene therapy at least 6 months after disease onset,” stated study authors, led by Robert C. Sergott, MD, from the Departments of Ophthalmology and Neurology at Wills Eye Hospital and Thomas Jefferson University, as well as the head of the Central Reading Center at William H. Annesley, Jr, EyeBrain Center.

“This relationship between preservation of retinal structures and response to treatment strongly supports an effect of lenadogene nolparvovec on [retinal ganglion cell, or] RGC survival and function. These findings should facilitate optimization of patient selection for future clinical trials.”

Researchers conducted univariate analyses on 113 eyes of patients in GenSight’s 3 phase 3 studies—RESCUE, REVERSE, and REFLECT—with BCVA and 1.5 years post treatment as the dependent variable.

 Age, gender, timing of treatment, baseline BCVA value, and baseline OCT parameters were noted as covariates. BCVA was assessed by using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 1 or 4 meters.

 Findings from the analysis indicated that “patients treated during the dynamic phase of the disease achieve better visual outcomes than patients treated during the subacute phase of the disease,” according to a GenSight news release.

Given these results, study authors hypothesize that RNFL swelling during the subacute phase may hamper the diffusion of the viral vector to RGCs. However, during the dynamic phase, study authors state that stabilized retinal layers are instead preserved, allowing for successful transfection efficiency of RGCs—and the effects of gene therapy as a result.

“Our results support the existence of a relationship between better GCL and RNFL preservation at baseline and final visual outcome in MT

 patients treated with gene therapy at least 6 months after disease onset, unequivocally linking structure with function,” the authors stated.

“The study is the first to use spectral domain-optical coherence tomography (SD-OCT) and other clinical outcomes to identify predictive factors of BCVA changes 1.5 years after treatment,” said Sergott in the release.

“The structural and functional evidence concurs that direct injection of lenadogene nolparvovec may be more effective than the contralateral therapeutic effect, thus supporting a recommendation to treat LHON patients bilaterally when possible.”

Study authors noted that limitations of the study include its exploratory nature, in addition to the absence of a pure sham/placebo control group. The inclusion of this group could provide insights into predictive factors of the outcome of the spontaneous evolution of MT-ND4 LHON disease. Findings were also limited to the administering of gene therapy during the subacute and dynamic phases of the disease.

GenSight Biologics announces publication of predictors of final visual outcome in patients treated with Lumevoq gene therapy. News release. GenSight Biologics. July 17, 2025. Accessed July 24, 2025. 

https://www.businesswire.com/news/home/20250717701196/en/GenSight-Biologics-Announces-Publication-on-Predictors-of-Final-Visual-Outcome-in-Patients-Treated-with-LUMEVOQ-Gene-Therapy

Sergott RC, Carelli V, Newman NJ, et al. Predictors of final visual outcome in patients with Leber hereditary optic neuropathy treated with lenadogene nolparvovec gene therapy. 

New research identifies key factors influencing visual recovery in Leber hereditary optic neuropathy patients treated with gene therapy, enhancing treatment strategies.

Exploratory analysis identifies predictors of improved BCVA in LHON

At the ASRS 2025 meeting, Jennifer I. Lim, MD, presented on the DAVIO-2 study comparing EYP-1901 with aflibercept for patients with neovascular AMD. She shared with 

 that the noninferiority trial showed that a single dose of EYP-1901 provided comparable vision results to repeated aflibercept treatments. The therapeutic candidate demonstrated a unique bioerodible, sustained-release mechanism potentially allowing 6-month dosing. Participants were high-need patients with extensive prior treatment, and the ongoing phase 3 study aims to further validate these promising initial findings.

Note: The following transcript has been lightly edited for clarity.

 Can you share a few highlights from your presentation at the 2025 ASRS meeting in Long Beach, California?

The DAVIO-2 study was a noninferiority study that compared EYP-1901 to aflibercept. Basically, it compared 1 dose of either low-dose EYP-1901, which is 2 mg, or high-dose EYP-1901, which is a 3-mg dose, to aflibercept, given every 8 weeks. These were the 3 arms of the study, and they were given in a randomized fashion, after 3 loading doses of aflibercept were given. During this study, which took 1 year, patients were allowed supplemental aflibercept based on prespecified criteria. 

Now, the primary end point was an average of weeks 28 and 32 best-corrected visual acuity for each of the arms. And basically, what was found was that despite the fact that only 1 dose of EYP-1901 was given, those arms had noninferior vision, as compared to the aflibercept arms, which received aflibercept every 8 weeks.

 How might this study inform future research?

 This is a really interesting study, I think, because it helps frame the treatment algorithm for the future, phase 3, which is actually ongoing right now and fully enrolled. So we're waiting to see what happens. Because of what we saw in the phase 2 studies, in phase 3, patients are dosed every 6 months, because this drug can last for 6 months. It's bioerodible. It's nonpegylated, and actually it results, actually, in a sustained release over the 6 months, which is also zero-order kinetics, and it's a very continuous dose. And I think it gives our patients another treatment option, in the future, that will prevent [these patients from having to have] redosing.

Were the patients in this study previously treated?

 The patients who were included in DAVIO-2 were patients who were previously treated for their neovascular AMD, and in fact, on average, they had had 10 prior anti-VEGF injections in the year prior to the enrollment. So these were high-needs patients.

The DAVIO-2 study reveals EYP-1901's potential as a 6-month treatment for neovascular AMD, matching aflibercept's vision outcomes with fewer doses.

Q&A: Jennifer I. Lim, MD, shares insights from the DAVIO-2 study

4D Molecular Therapeutics announced positive results from the SPECTRA clinical trial evaluating 4D-150 in patients with 

. The data, including 52-week primary end point and 60-week analyses, were presented at this year's Annual American Society of Retina Specialists (ASRS) Scientific Meeting.

4D-150 is an investigational agent designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. It utilizes the company’s customized and evolved intravitreal vector, R100.

David Almeida, MD, MBA, PhD, who presented the data at the event, commented, “The positive results from the SPECTRA trial demonstrate the tolerability and consistent, durable clinical activity of 4D-150 in DME, […] 4D-150 has the potential to fundamentally transform the treatment of DME by reducing treatment burden with a product that has adherence by design while providing meaningful, lasting vision improvement. This is especially important in DME, which frequently occurs in a working-age population.”

For the SPECTRA trial, the primary objective was to evaluate safety and tolerability and identify the dose level for further evaluation. The study enrolled 22 patients across 3 dose levels, including the phase 3 dose of 3E10 vg/eye (n=9) and supplemental doses of 1E10 vg/eye (n=12) and 5E9 vg/eye (n=1). It was noted that 2 patients dosed in the 1E10 vg/eye missed over 50% of study visits and were considered not evaluable for injection burden or other efficacy parameters.

According to the data, 4D-150 is well tolerated with no intraocular inflammation at any timepoint over 60 weeks. Additionally, no patients required any modification to the topical corticosteroid regimen.

Patients in the phase 3 dose (3E10 vg/eye [n=9]) sustained a gain of best corrected visual acuity (BCVA) of +9.7 letters, with a reduction of CST, as measured by optical coherence tomography (OCT), of -174 µm.

Additionally, patients treated with the phase 3 dose required substantially fewer supplemental injections compared with patients receiving lower doses or projected on-label aflibercept 2 mg Q8W.

The mean supplemental injections per patient were 1.6 for those who received the phase 3 dose and 3.7 for those on the lower doses. Of the 11 valid participants in the lower doses, only 1 patient was injection-free, whereas 4 of the 9 in phase 3 were.

David Kirn, MD, cofounder and CEO of 4DMT, commented, “The consistency of dose response, safety, and efficacy data we’ve seen with 4D-150 across all patients evaluated in both DME and wet AMD reinforces our belief that 4D-150 has the potential to become a true backbone therapy and may significantly improve the lives of millions of patients living with retinal vascular disease.”

Following US Food and Drug Administration (FDA) alignment, as communicated in 

, the EMA is also aligned that a single phase 3 clinical trial, based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials combined with data from the 2 planned phase 3 clinical trials in the 4FRONT wet AMD program, would be acceptable as the basis for a marketing authorization application (MAA) submission for 4D-150 in DME.

4DMT Presents Positive 60-Week Results from 4D-150 SPECTRA Clinical Trial in DME and Regulatory Update. Published July 31, 2025. Accessed August 4, 2025. 

https://www.globenewswire.com/news-release/2025/07/31/3125378/0/en/4DMT-Presents-Positive-60-Week-Results-from-4D-150-SPECTRA-Clinical-Trial-in-DME-and-Regulatory-Update.html

4D Molecular Therapeutics showcases promising SPECTRA trial results for 4D-150, highlighting its potential to revolutionize diabetic macular edema treatment.

4DMT reports positive SPECTRA results in DME trial

The 2025 annual meeting of the American Society of Retina Specialists was held in Long Beach, California, from July 30 through August 2, 2025. At this event, Robert A. Sisk, MD, FACS, FASRS, gave a presentation titled, "Subretinal Laru-zova Gene Therapy for XLRP: 24-Month Results of the Randomized, Controlled, Multicenter Phase 2 SKYLINE Trial."

caught up with Sisk at the meeting to discuss these trial results and how they might impact future candidates and research into X-linked retinitis pigmentosa (XLRP).

Note: The following conversation has been lightly edited for clarity.

Can you share key highlights from your presentation on the phase 2 SKYLINE trial at ASRS 2025?

SKYLINE was a phase 2 trial looking at the dose-dependent response of laru-zova, which is a full-length RPGR gene therapy, and trying to look at groups from the previous phase 1/2 study that showed some benefit, groups 2 and 5 from HORIZON. Ultimately, we're trying to see with a larger patient base, does that stratify out to a benefit that's greater in 1 group than the other? And we did see that in the high-dose group, there was a significant improvement in microperimetry response, which is essentially visual sensitivity in the central retina, the portion that's treated with the gene therapy, compared to the low-dose group.

What patient population makes up this study?

Males aged 8 to 50 years, who had a demonstrated pathogenic variance in the gene 

, which is the most common gene that causes X-linked retinitis pigmentosa, were able to participate, but they also had to have measurable microperimetry sensitivity so that they could demonstrate an increase with treatment or a decrease if there was a safety issue. And an intact foveal ellipsoid band, which is an anatomic marker that shows the integrity and health of the light-catching cells, or photoreceptors, at the area of the retina that provides the best vision?

Were there any surprising or unexpected results in these data?

Well, I think not so much from this particular study, but when we look at the HORIZON patients, it was clear that those patients who had the measurable microperimetry and the intact ellipsoid band were those who were more likely to benefit from the gene therapy. And that has been something that we've seen in a variety of other gene therapy trials. It seems like the ellipsoid zone is important. Having near-normal retinal anatomy in that area is important to see the benefit of the gene therapy.

How might these results shape a phase 3 trial or future XLRP research?

 So the exciting thing is that the phase 3 [VISTA] trial is not just under way, but it's actually already fully recruited. So this trial was important in verifying the vision benefit from microperimetry. An almost parallel trial called DAWN helped to establish low luminance visual acuity is another important metric of potential visual improvement, and both of those are being looked at as primary end points for the VISTA study.

Did this study provide any insights into retinitis pigmentosa as a disease state? If so, what have we learned?

I think what we're learning is that there is, at least, with the gene therapy trials, somewhat of a narrow window in which we can treat these patients. Patients have to have some diminished vision. In the trial, it was 20/32 to 20/200. They have to have some diminished vision. Otherwise, there's a ceiling effect in terms of being able to see improvement in visual acuity. But as the visual acuity declines, there's also typically loss of the ellipsoid band. So if there's total loss of the ellipsoid band, those patients are not candidates. So from a clinical trial perspective, it's a narrow window where there's a beginning of vision decline, but not so much that it's taken away that anatomic parameter that would allow the vision to benefit. I'm hopeful that if this gets approved, following the phase 3 study, that we'll be able to treat patients at an earlier age who may be able to benefit rather than having such a narrow recruiting window.

 As you consider the pipeline potential therapeutics for treating patients with retinitis pigmentosa, what do you hope the future holds?

 I'm hopeful that we'll see a variety of different therapeutic options. It's very exciting to see one trial making it all the way to phase 3. But we really want patients to not just have gene augmentation therapy, but also, we want some gene agnostic approaches, like stem cell studies, optogenetic gene therapy for patients with really late-stage disease. So I think in the end, in clinical practice, we'll have therapies that harmonize and really give a more complete outcome for those patients.

Federico Badalà, MD

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