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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.

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

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

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

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 new Chinese report recognized that social media smartphone application–based interventions significantly improved follow-up adherence and increased parental knowledge among families of children with congenital ectopic lentis,

 according to Yiyuan Ma, MD, who is from the State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, China.

Congenital ectopia lentis is a rare ocular disease characterized by the dislocation or displacement of the lens.

The disease is most often attributed to disorders that disrupt the fibrillin-rich microfibrils of the ciliary zonule, affecting its structure and function. Ectopia lentis usually results in reduced visual acuity due to induced refractive error in the first instance. The most common causes of ectopia lentis include Marfan syndrome and related type-1 fibrillinopathies, trauma, homocystinuria, and Weill–Marchesani syndrome. In addition to the refractive effects, subluxation or luxation can lead to sectoral shallowing of the anterior chamber, subluxation of the lens into the anterior chamber, and glaucoma.

Ma and colleagues emphasized that ectopic lentis requires rigorous postoperative follow-up to reduce the risk of severe complications. However, follow-up rates often can be suboptimal, indicating an urgent need for effective interventions to improve adherence.

To fill this gap, the investigators assessed the effect of WeChat (Tencent Holdings Ltd.), a social media smartphone communication application, which delivers telephone reminders and health education to improve the families’ adherence to postoperative follow-up of children with congenital ectopic lentis.

They conducted a randomized clinical trial (

) at the Zhongshan Ophthalmic Center, a tertiary ophthalmic hospital in Guangzhou that included families with children who were scheduled for lens surgery to address congenital ectopic lentis. The families were randomized to either the social media group of the standard care group.

The parents were contacted before the scheduled appointments at 1 week and 1 and 3 months postoperatively, and at those times those randomized to the social media intervention group received phone reminders and health education via the smartphone application. The main outcome was the follow-up attendance at 3 months postoperatively.

The study included 110 children (58.2% males) divided equally into 2 study groups.

The investigators reported, “The intervention group exhibited higher attendance rates than the standard-care group across all three postoperative follow-up visits (3 months: 83.6% vs 41.8%; 1 month: 81.8% vs 58.2%; and 1 week: 92.7% vs 87.3%, respectively).” The difference at the 3-month evaluation reached significance (

The children in the social media group also had greater improvements in the accurate parental knowledge about congenital ectopic lentis (10.6%, 95% CI, 7.8%-13.5%) and higher rates of amblyopia treatments (RR, 2.40; 95% CI, 1.26-4.56).

“The results of this randomized clinical trial reveal that social media smartphone application–based interventions significantly improved follow-up adherence and increased parental knowledge among families of children with congenital ectopic lentis. These findings suggest that integrating mobile health technologies into standard care can enhance the management of progressive pediatric conditions with systemic risks, ultimately improving clinical outcomes,” Ma and colleagues concluded.

Ma Y, Zhang X, Jin L, et al. Social media interventions and postoperative follow-up in congenital ectopia lentis. A randomized clinical trial. 

 Published online April 10, 2025. doi:10.1001/jamaophthalmol.2025.0526

Xu P, Ng K, Jin L, et al. Visual prognosis and complications of congenital ectopia lentis: study protocol for a hospital-based cohort in Zhongshan Ophthalmic Center. 

Lambert SR, Lyons CJ, eds. The lens. Taylor and Hoyt’s Pediatric Ophthalmology and Strabismus. 2017;Chapter 36, 5th ed., pp.337-345.e1; Elsevier, Amsterdam, the Netherlands; https://doi.org/10.1016/B978-0-7020-6616-0.00036-0

Canonical

Effect of social media on follow-up in congenital ectopia lentis

Eyestem Research announced positive results from its phase 1 trial (

) evaluating its investigational drug product, Eyecyte-RPE, in patients with 

dry age-related macular degeneration (AMD).

 in its trial in August 2024. The trial treated 9 patients in 3 sequential, ascending dose-level (DL) cohorts. The 3 dose levels were Eyecyte-RPE at 100,000; 200,000; and 300,000 cells. Eyecyte-RPE is a suspension of hiPSCs (human induced pluripotent stem cells) derived retinal pigment epithelial (RPE) cells.

The company stated that no serious adverse events were reported across all 3 cohorts, and the first 6 patients had an average improvement of 14.9 letters in early treatment diabetic retinopathy study (ETDRS) standard vision tests within 4 to 6 months post-transplantation. The company also noted that “retinal imaging scans revealed early signs of disease reversal in a handful of patients.”

Jogin Desai, founder and CEO of Eyestem commented on the results in a press release from the company.

“The substantial vision improvement, sustained over a 4-6-month period in all 6 patients, combined with an excellent safety profile, has been very encouraging and has the potential to reshape the landscape of GA treatment globally. It is especially rewarding to see the improvement in the quality of life in these patients. We look forward to exploring these early results further in our phase two study in India and the US," said Desai.

Eyestem plans to present data from the trial at the upcoming ARVO 2025 annual meeting.

Eyestem’s Eyecyte-RPE trial shows vision rescue for geographic atrophy patients. Published April 14, 2025. Accessed April 14, 2025. 

https://economictimes.indiatimes.com/small-biz/sme-sector/eyestems-eyecyte-rpe-trial-shows-vision-rescue-for-geographic-atrophy-patients/articleshow/120271413.cms

Safety & efficacy of Eyecyte-RPE™ in patients with geographic atrophy secondary to dry age-related macular degeneration. NCT06394232. Accessed April 14, 2025. 

https://clinicaltrials.gov/study/NCT06394232

Eyecyte-RPE is a suspension of human induced pluripotent stem cells derived from retinal pigment epithelial cells.

clinical

Eyestem reports promising phase 1 trial results in patients with geographic atrophy

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) from Regeneron for the high-dose (HD) formulation of aflibercept (EYLEA HD).

The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following 

, and for broadening the dosing schedule to include every 4-week, or monthly, dosing across approved indications. The company noted that the FDA target action date is August 19, 2025, following the use of a priority review voucher.

The HD formulation is a longer-acting version of the original aflibercept drug, and through less frequent injection, it is designed to be more convenient to the patient, reducing treatment burden. In August 2023, data from Regeneron’s Phase III PULSAR trial confirmed that even at dosing intervals at least 12 weeks long, high-dose Eylea did not sacrifice vision gains while also helping patients maintain their treatment schedules.

The sBLA is supported by data from the phase 3 QUASAR trial investigating EYLEA HD in RVO. As 

showed that it met its primary endpoint at 36 weeks, with both groups of EYLEA HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA (aflibercept) Injection 2 mg dosed every 4 weeks.

The safety profile of EYLEA HD in the QUASAR trial was similar to EYLEA and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials. The company did note that increased ocular pressure (5%) was the only ocular treatment-emergent adverse event that occurred in ≥5% of all EYLEA HD patients, compared to 1.7% of EYLEA patients.

Regeneron has also filed an application with the FDA for the use of pre-filled syringes (PFS) of high-dose aflibercept in the US. Approval and launch of these PFSs are expected by mid-2025.

 Additionally, Bayer announced the submission of an application to the European Medicines Agency (EMA) seeking to expand the indication for aflibercept 8mg. Aflibercept is being jointly developed by Bayer and Regeneron.

EYLEA HD (aflibercept) injection 8 mg sBLA accepted for FDA Priority Review for both the treatment of macular edema following retinal vein occlusion (RVO) and for monthly dosing in approved indications. Published April 17, 2025. Accessed April 17, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-sbla-accepted-fda-priority

FDA Action Alert: Regeneron, Sanofi and Abeona. BioSpace. April 14, 2025. Accessed April 15, 2025. 

https://www.biospace.com/fda/fda-action-alert-regeneron-sanofi-and-abeona

Harp M. Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg. 

 Published February 10, 2025. Accessed April 17, 2025. 

https://www.ophthalmologytimes.com/view/regeneron-reveals-positive-results-from-multiple-trials-evaluating-eylea-hd-aflibercept-injection-8-mg

Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference. Regeneron. January 13, 2025. Accessed April 15, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-business-updates-and-highlights-broad/

Hayes, H. Bayer files EMA application for aflibercept 8mg in third indication, retinal vein occlusion. 

 April 9, 2025. Accessed April 14, 2025. 

https://www.modernretina.com/view/bayer-files-ema-application-for-aflibercept-8mg-in-third-indication-retinal-vein-occlusion

The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion, and for broadening the dosing schedule to include every-4-week dosing across approved indications.

FDA accepts Regeneron's sBLA for Eylea HD as priority review

Regeneron has proposed a longer dosing duration for the high-dose (HD) formulation of aflibercept (EYLEA HD). The FDA is expected to release is decision on this dosing duration by April 20, 2025.

This dosing extension information was shared during Regeneron’s presentation at the J.P. Morgan Healthcare Conference in January of 2025, noting that at the time of the presentation FDA was already reviewing its application for 24-week dosing for Eylea HD in wet age-related macular degeneration (AMD) and diabetic macular edema (DME). 

The company has also filed an application with the FDA for the use of pre-filled syringes (PFS) of high-dose aflibercept with the US. Approval and launch of these PFS is expected by mid-2025.

It was also during this conference that the company noted that there are plans to submit a supplemental biologics license application (sBLA) for high-dose aflibercept with an up to 8-week dosing schedule for retinal vein occlusion (RVO). This comes after the completion of the phase 3 QUASAR trial of aflibercept 8 mg (EYLEA HD), which met its primary endpoint, in December of 2024.

QUASAR is a global, double-masked, active-controlled phase 3 trial evaluating the efficacy and safety of EYLEA HD, compared to EYLEA, in patients with RVO, including those with central, branch, and hemiretinal vein occlusions. In the trial, patients were treated with an 8-week dosing regimen of EYLEA HD, following 3 or 5 initial monthly doses, while EYLEA patients were treated every 4 weeks.

Bayer announced the submission of an application to the European Medicines Agency (EMA) seeking to expand the indication for aflibercept 8mg. Aflibercept is being jointly developed by Bayer and Regeneron.

The HD formulation is a longer-acting version of the original aflibercept drug and through less frequent injection, it is designed to be more convenient to the patient, reducing treatment burden. In August 2023, data from Regeneron’s Phase III PULSAR trial confirmed that even at dosing intervals at least 12 weeks long, high-dose Eylea did not sacrifice vision gains while also helping patients maintain their treatment schedules.

Positive 3-year results were shown from an extension study of the phase 3 PULSAR trial. According to the company, the longer-term wet age-related macular degeneration (wAMD) data demonstrated the vast majority of EYLEA HD patients who entered the extension study sustained the visual gains and anatomic improvements achieved by the end of the second year, while also achieving substantially longer treatment intervals. Additionally, patients who switched from EYLEA Injection 2 mg to EYLEA HD at the beginning of the third year were also able to maintain vision and anatomic improvements through the end of the third year, but with longer dosing intervals and fewer injections.

FDA Action Alert: Regeneron, Sanofi and Abeona. BioSpace. April 14, 2025. Accessed April 15, 2025. 

Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference. Regeneron. January 13, 2025. Accessed April 15, 2025. https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-business-updates-and-highlights-broad/

EYLEA HD® (aflibercept) Injection 8 mg Phase 3 Trial Meets Primary Endpoint Showing Improved Vision with Extended Dosing Intervals in Patients with Macular Edema following Retinal Vein Occlusion. Press Release; December 17, 2024. Accessed April 15, 2025. 

https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-phase-3-trial-meets-primary

Hayes, H. Bayer files EMA application for aflibercept 8mg in third indication, retinal vein occlusion. 

 April 9, 2025. Accessed April 14, 2025. https://www.modernretina.com/view/bayer-files-ema-application-for-aflibercept-8mg-in-third-indication-retinal-vein-occlusion

Harp, MD. Regeneron reveals positive results from multiple trials evaluating Eylea HD (aflibercept) injection 8 mg. 

 February 10, 2025. Accessed April 15, 2025. https://www.modernretina.com/view/regeneron-reveals-positive-results-from-multiple-trials-evaluating-eylea-hd-aflibercept-injection-8-mg

A decision on a longer dosing duration for the high-dose formulation is expected by April 20, 2025.

David Hutton

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