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NEW DAY trial of ILUVIEN for DME does not meet primary endpoint, post-hoc analysis suggests potential benefits

Sheryl brings a wealth of editorial experience to MJH Life Sciences’ Eye Care Network, having engaged with the readers and the greater ophthalmic community of 

for more than 20 years. As Group Editorial Director, Sheryl’s purview extends across the print and digital network of 

Ophthalmology Times, Ophthalmology Times Europe, Modern Retina 

 Prior to ophthalmology, Sheryl previously covered the fields of audiology and confectionery science/technology/manufacturing.

Sheryl is also passionate about the mission, vision and values of Ophthalmic World Leaders (OWL) and recently completed her term on its Board of Directors. She continues to volunteer as Editor-in-Chief of the organization’s 

Magazine. In 2013, she was honored with the group’s inaugural Rising Star Award.

In addition, she has served as a judge for 

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Q&A: Natalie Afshari, MD, FACS, championing on-label pediatric IOLs: turning advocacy into access

Vonaprument has received fast track designation from the US Food and Drug Administration.

Annexon completes enrollment in phase 3 ARCHER II trial of vonaprument for geographic atrophy

KIO-104 is for the treatment of a wide range of ocular diseases, including ocular inflammation, uveitis, age-related macular degeneration (AMD), and complications as a result of refractive surgery.

Kiora Pharmaceuticals Secures US Patent for KIO-104 

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Accreditation programs demonstrate a strong commitment to excellence in patient safety, standardized quality, fiscal responsibility, and collaboration between patients and health care workers. 

Importance of accreditation in global eye health care

The 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting will take place May 4-8, 2025, in Salt Lake City, Utah. Ahead of this exciting meeting, several companies have announced that data from clinical trials will be shared at this event.

As researchers prepare for their presentations, we are highlighting some of the scheduled sessions that will share important data and research from around the globe.

Note: The following list of presentations is in alphabetical order by company and will be updated as more information becomes available.

The company will share results from its clinical studies of investigational oral gildeuretinol for the treatment of Stargardt disease (TEASE) and geographic atrophy secondary to age-related macular degeneration (SAGA) at the 2025 ARVO annual meeting.

Safety and Efficacy of Oral Gildeuretinol for Stargardt Disease: TEASE-1 Trial

Presented by Benjamin Bakall, MD, PhD on Monday, May 5, 2025 at 4:30 PM to 4:45 PM MT

Oral Gildeuretinol Treatment in Geographic Atrophy Secondary to AMD in the SAGA Trial: Safety, Efficacy and Patient-reported Outcomes

Presented by David Boyer, MD, on Tuesday, May 6, 2025 at 4:45 PM to 5:00 PM MT

Jeff Cleland, PhD, CEO of Ashvattha Therapeutics, will present a poster entitled “Subcutaneous Migaldendranib Reduces Anti-VEGF Treatment Burden: A Unique Therapeutic Platform to Treat Retinal Vascular Disease” during the poster session on Wednesday, May 7, 2025, from 2:00-3:45pm MT.

This poster will highlight Phase 2 results for migaldendranib (MGB), Ashvattha’s investigational subcutaneous treatment for wet 

age-related macular degeneration (wet AMD)

. It was previously announced that the 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.

The company will have presentations that highlight its advancing ocular gene therapy, including the development of its proprietary VSaf AAV manufacturing platform and therapeutic candidate ABI-201, a single AAV vector carrying 3 functional genes to treat dry AMD.

A Fast and Robust VSaf AAV Platform Technology for Producing High Quality and Yield of AAV Vectors for Ocular Gene Therapy

Presented by Shengjiang Liu, PhD on Wednesday, May 7, 2025 from 2:15 PM to 2:30 PM MT.

Protective Efficacy of ABI-201 in a Sodium Iodate-Induced Retinal Damage Model of Dry AMD in Non-Human Primates

Presented by Sameera Peraramelli, PhD on Monday, May 5, 2025 from 3:00 PM to 4:45 PM MT

Advancing Retinal Disease Research: The Sodium Iodate NHP Model for Translational Therapeutic Evaluation

Presented on May 4, 2025 from 1:00 PM to 1:30 PM MT

At the meeting, Beacon Therapeutics is set to present 6-month interim safety and efficacy results from the Phase 2 DAWN trial of the Company's lead program, laru-zova (laruparetigene zovaparvovec), in patients with X-linked retinitis pigmentosa (XLRP). The presentation is titled, "Subretinal gene therapy laru-zova (AGTC-501) for X-linked retinitis pigmentosa (XLRP): Phase 2 DAWN preliminary month 6 results" and will be given by Mark Pennesi, MD, PhD, FARVO, on Tuesday, May 6, 2025.

Six abstracts related to Clearside’s suprachoroidal drug delivery platform have been accepted for presentation at the 2025 ARVO meeting.

Top Line Results from ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-related Macular Degeneration

Presented by Robert Wang on Thursday, May 8, 2025, from 3:00 pm - 3:15 pm MT.

Suprachoroidal CLS-AX (Axitinib Injectable Suspension) Offers Durability, Safety, and Therapeutic Potential for Neovascular Age-Related Macular Degeneration (nAMD) Patients: Preclinical and Clinical Corroboration

Posterboard number A0125 presented by Viral Kansara, PhD on Wednesday, May 7, 2025, from 10:15 am - 12:00 pm MT

The Evolving Role of Suprachoroidal Drug Delivery in Macular Diseases: A Decade-Long Literature Review

Posterboard number B0517 presented by Victor Chong, MD, MBA on Monday, May 5, 2025, from 8:30 am - 10:15 am MT

Validation of Suprachoroidal Injection Training Program with a Synthetic Eye Model

Posterboard number B0415 presented by Chen-rei Wan on Thursday, May 8, 2025, from 8:00 am - 9:45 am MT

Dispensability Analysis of Suspension Formulations

Posterboard number B0515 presented by Darrin Rountree, MS on May 5, 2025, from 8:30 am - 10:15 am MT

Novel Deep Learning Algorithm for Suprachoroidal Space Segmentation and Measurement in Optical Coherence Tomography

Posterboard number A0229 presented by Oluwagbemisola Aderibigbe on May 4, 2025, from 1:00 pm - 2:45 pm MT

Doheny Eye Institute announced that more than 25 of its scientists and clinician-scientists will present their latest research at the 2025 ARVO Annual Meeting. In addition to a strong lineup of presenters, Doheny will also be well represented as SriniVas R. Sadda, MD, closes out his term as president of ARVO at the culmination of the 2025 meeting.

A complete list and schedule for all the Doheny Eye Institute and UCLA Stein Eye Institute research presentations is available 

Data from EyePoint has been accepted for presentation at the upcoming 2025 ARVO Annual Meeting. The company plans to showcase its clinical trial datasets for is phase 2 VERONA trial and phase 2 DAVIO 2 trial, which across multiple indications saw continued safety and efficacy, as well as the program’s de-risked study designs that reflect real-world patient populations.

Eyestem has recently shared that all patients across 3 cohorts in the company’s phase 1 trials of its investigational drug, Eyecyte-RPE, in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) were dosed without any serious adverse events. The first 6 patients showed an average 14.9-letter gain in ETDRS vision tests within 4–6 months, with early signs of disease reversal seen in some retinal scans. Data from this trial will be presented at the ARVO meeting.

The company will present new developments and updates on its lead candidate, ILYX-002, for immune-driven 

 from a recent Phase 2 clinical trial, ILYX-002-201. The presentation will take place during the Dry Eye: Clinical Aspects II session on May 8, 2025, 8:00 am – 9:45 am MST. Dr. Mark Hinds, principal investigator for the ILYX-002-201 trial, will be the presenter on the company’s behalf.

Luxa Biotechnology said it will present clinical results for its investigational dry age-related macular degeneration (AMD) cell therapy candidate, RPESC-RPE-4W, at the 2025 ARVO Annual Meeting. The data from cohort 1 of its phase 1/2a clinical trial evaluating RPESC-RPE-4W, a retinal pigment epithelium (RPE) cell therapy derived from adult retinal pigment epithelial stem cells (RPESCs).

The company is scheduled to participate at both the Eyecelerator and the 2025 ARVO annual meetings. Nanoscope's presentations will be centered around 126-week outcomes following treatment with its MCO-010 optogenetic therapy for retinitis pigmentosa (RP), the first and only therapy shown to restore vision in advanced RP patients via a one-time, standard intravitreal injection.

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.

Ocugen, Inc. will present on its modifier gene therapy platform, including OCU400 for the treatment of retinitis pigmentosa (Phase 3 LiMeliGhT clinical trial), OCU410ST for the treatment of Stargardt disease (Phase 2/3 pivotal confirmatory clinical trial), and OCU410 for the treatment of geographic atrophy (Phase 2 ArMaDa clinical trial) at the 2025 ARVO Annual Meeting.

Three abstracts on the company’s investigational gene therapy candidates have been accepted for presentation at the ARVO 2025 Meeting. The abstracts feature 12-month data from the first 3 adult patients in the ongoing Phase 1/2 trial of OPGx-LCA5, as well as preclinical results on OPGx-MERTK and OPGx-RDH12.

Evaluation of MERTK gene therapy in RCS rats following a single bilateral subretinal injection

Presented by Mayur Choudhary, PhD, on May 8, 2025, from 11:45 am to 1:30 pm MT.

Evaluation of ocular tolerability of OPGx-RDH12 by subretinal delivery in cynomolgus primates

Presented by Ash Jayagopal, PhD, on May 5, 2025, from 8:30 am to 10:15 am MT

LYNX-1 Phase 3 trial of the safety and efficacy of phentolamine ophthalmic solution for the treatment of reduced mesopic low contrast vision: A subset analysis of keratorefractive subjects

Presented by Kostas Charizanis, PhD on May 4, 2025 from 8:00 am to 9:45 am MT

The company's data will feature in several presentations at the ARVO annual meeting. These include new data on bevemipretide, the company's next-generation ocular topical investigational medicine, including protective effects observed in models of dry age-related macular degeneration (AMD) and glaucoma, and preclinical toxicology and exposure data informing the company's planned Phase 1 study.

TME Pharma N.V. and the Singapore Eye Research Institute (SERI) will present a poster highlighting data from preclinical studies performed with mNOX-E36 by SERI at the ARVO Annual Meeting. Preclinical data show that mNOX-E36 is as efficacious as standard-of-care mitomycin C (MMC) at attenuating postoperative inflammation and scarring (fibrosis) following glaucoma filtration surgery (GFS).

The poster will be titled “Inhibition of MCP-1 with mNOX-E36 reduces scarring in an experimental murine model of glaucoma filtration surgery” and will be posterboard number A0418. It will be presented by Professor Tina Wong on May 06, 2025, from 8:30 am – 10:15 am MT.

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

Clearside Biomedical Announces Six Abstracts Accepted for Presentation at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting. Clearside Biomedical. March 24, 2025. Accessed April 16, 2025. https://www.globenewswire.com/news-release/2025/03/24/3047721/0/en/Clearside-Biomedical-Announces-Six-Abstracts-Accepted-for-Presentation-at-Association-for-Research-in-Vision-and-Ophthalmology-ARVO-2025-Meeting.html

EyePoint Reports Fourth Quarter and Full-Year 2024 Financial Results and Highlights Recent Corporate Developments. EyePoint Pharmaceuticals. March 5, 2025. Accessed April 16, 2025. 

https://www.globenewswire.com/news-release/2025/03/05/3037277/0/en/EyePoint-Reports-Fourth-Quarter-and-Full-Year-2024-Financial-Results-and-Highlights-Recent-Corporate-Developments.html

Eyestem’s Eyecyte-RPE™ Trial Shows Vision Rescue for Geographic Atrophy Patients. Eyestem Research. April 15, 2025. Accessed April 16, 2025. https://www.businesswire.com/news/home/20250414346272/en/Eyestems-Eyecyte-RPE-Trial-Shows-Vision-Rescue-for-Geographic-Atrophy-Patients

Iolyx Therapeutics to Present at Multiple Upcoming Ophthalmology Conferences. Iolyx Therapeutics, Inc. March 12, 2025. Accessed April 16, 2025. https://www.globenewswire.com/news-release/2025/03/12/3041356/0/en/Iolyx-Therapeutics-to-Present-at-Multiple-Upcoming-Ophthalmology-Conferences.html

Opus Genetics Announces Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting. Opus Genetics. March 5, 2025. Accessed April 16, 2025. https://www.globenewswire.com/news-release/2025/03/05/3037375/0/en/Opus-Genetics-Announces-Presentations-at-Association-for-Research-in-Vision-and-Ophthalmology-ARVO-2025-Meeting.html

TME Pharma Announces Filing of Patents for Use of CCL2 Inhibitor NOX-E36 in Ophthalmology and Presentation at ARVO 2025 of Preclinical Data Showing Benefit in Glaucoma Filtration Surgery. TMR Pharma N.V. March 13, 2025. Accessed April 16, 2025. https://www.businesswire.com/news/home/20250313839845/en/TME-Pharma-Announces-Filing-of-Patents-for-Use-of-CCL2-Inhibitor-NOX-E36-in-Ophthalmology-and-Presentation-at-ARVO-2025-of-Preclinical-Data-Showing-Benefit-in-Glaucoma-Filtration-Surgery

Avirmax Biopharma Inc. to Present at the 2025 ARVO Annual Meeting in Salt Lake City. Avirmax Biopharma Inc. April 23, 2025. Accessed April 24, 2025. https://www.prnewswire.com/news-releases/avirmax-biopharma-inc-to-present-at-the-2025-arvo-annual-meeting-in-salt-lake-city-302436454.html

Doheny Eye Institute Announces Upcoming Presentations at the Association for Research in Vision and Ophthalmology 2025 Annual Meeting. Doheny Eye Institute. April 16, 2024. Accessed April 24, 2025. https://www.globenewswire.com/news-release/2025/04/16/3062586/0/en/Doheny-Eye-Institute-Announces-Upcoming-Presentations-at-the-Association-for-Research-in-Vision-and-Ophthalmology-2025-Annual-Meeting.html

Alkeus Pharmaceuticals Announces Presentations of Gildeuretinol Data During the Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting May 4-8, 2025. Alkeus Pharmaceuticals. April 24, 2025. Accessed April 25, 2025. https://www.globenewswire.com/news-release/2025/04/24/3067634/0/en/Alkeus-Pharmaceuticals-Announces-Presentations-of-Gildeuretinol-Data-During-the-Research-in-Vision-and-Ophthalmology-ARVO-2025-Annual-Meeting-May-4-8-2025.html

Beacon Therapeutics Announces ARVO 2025 Presentation on Preliminary 6-Month Data from its Phase 2 DAWN Trial of laru-zova in Patients with X-linked Retinitis Pigmentosa (XLRP). Beacon Therapeutics. April 24, 2025. Accessed April 25, 2025. https://www.prnewswire.com/news-releases/beacon-therapeutics-announces-arvo-2025-presentation-on-preliminary-6-month-data-from-its-phase-2-dawn-trial-of-laru-zova-in-patients-with-x-linked-retinitis-pigmentosa-xlrp-302437302.html

Stealth BioTherapeutics to Present New Bevemipretide Data at ARVO Annual Meeting. Beacon Therapeutics. April 24, 2025. Accessed April 25, 2025. https://www.prnewswire.com/news-releases/stealth-biotherapeutics-to-present-new-bevemipretide-data-at-arvo-annual-meeting-302436558.html

Luxa Biotechnology to present interim clinical data for dry AMD cell therapy at ARVO 2025. Luxa Biotechnology. April 28, 2025. Accessed April 28, 2025. https://www.koreabiomed.com/news/articleView.html?idxno=27413

Nanoscope Therapeutics Announces Participation at Eyecelerator and ARVO 2025 Annual Meetings. Nanoscope Therapeutics. April 25, 2025. Accessed April 28, 2025. https://firstwordpharma.com/story/5953086

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

Ocugen to Present on Modifier Gene Therapy Platform at Association for Research in Vision and Ophthalmology 2025 Annual Meeting and Retina World Congress. 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

The 2025 ARVO Annual Meeting in Salt Lake City will feature presentations from various companies showcasing significant advancements in ophthalmology. Ashvattha Therapeutics will present Phase 2 results for migaldendranib, a treatment for retinal vascular diseases. Clearside Biomedical will discuss its suprachoroidal drug delivery platform. EyePoint Pharmaceuticals will share data from its Phase 2 trials. Eyestem Research will present promising results from its Eyecyte-RPE trial. Iolyx Therapeutics, Opus Genetics, and TMR Pharma N.V. will also present their latest research findings and developments in ophthalmic treatments.

The annual ARVO meeting will be held in Salt Lake City, Utah and feature presentation on clinical trials from around the globe. 

Companies announce presentations at upcoming 2025 ARVO Annual Meeting

A new therapeutic approach that combines eyelid pressure patching with the application of decellularized, dehydrated pure amniotic membrane basement membrane (AMBM), a type of amniotic membrane tissue (AMT), was highly successful and safe for healing persistent corneal epithelial defects,

 according to Kyle Linsey, MD, who is from the Cornea Service, Clearwater Eye and Laser Center, Clearwater, FL, and HCA Florida Bayonet Point Hospital, University of South Florida, Tampa.

Managing persistent corneal epithelial defects can be tricky, and, according to Linsey, typically consists of treatments such as frequent lubrication, immunomodulators, steroids, autologous serum or platelet-rich plasma tears, bandage contact lens, punctal occlusion, and in more advanced disease, pressure patching, epithelial debridement, scleral contact lenses, cenegermin, and AMT.

AMT offers a number of advantages to patients that includes rapid re-epithelialization of the persistent corneal epithelial defects in cases refractory to treatment,

 by addressing the ocular surface inflammation,

 at rates of re-epithelialization of 45.5% to 74.7%, independent of ulcer etiology.

 The treatment does not transfer viable stem cells

 but “supports damaged tissue, protects and shields defects from further degeneration or breakdown from external factors and promotes re-cellularization,

In addition, AMT stimulates proliferation and migration of limbal stem cells, suppresses neo-angiogenesis, inflammation, and scarring, contributes to AMT’s ability to support the healing of ocular surface disease

 and physically acts as a substrate for epithelial cell growth.

Multilayer AMT has been proposed for treating deep neurotrophic corneal ulcers

 and is more effective than autologous serum at healing corneal ulcers resulting from herpetic neurotrophic keratitis.

In his retrospective study, Linsey analyzed 144 eyes treated with either a single-layer or three-layer decellularized AMBA (Biovance 3L Ocular; Verséa Ophthalmics, Inc.) combined with a 24-hour eyelid pressure patch; 90% were treated with a single layer of AMBM and 10% with three layers of AMBM.

In the single-layer group, Linsey reported, all cases healed completely and the AMBM dissolved. In the three-layer group, all cases had improvements in the corneal staining; however, the AMBM did not dissolve in 20% to 30% of cases. No patients reported pain, discomfort, or infection.

This study found that combining eyelid pressure patching with AMT is a safe and effective approach for healing persistent corneal epithelial defects.

“AMT promotes epithelial cell proliferation, reduces inflammation and neuropathic pain, and limits scar formation.

 AMT can act as a mechanical barrier to protect the ocular surface, prevent evaporation and dryness, and maintain a stable tear film while serving as a scaffold for donor–recipient cell migration and integration.

 The integration of an eyelid pressure patch with dehydrated, decellularized AMBM treatment for advanced ocular surface disease leads to accelerated corneal healing and increased patient comfort,” Linsey concluded.

Linsey K. Use of an eyelid pressure patch concomitantly with a decellularized dehydrated amniotic membrane for ocular surface disease management. 

https://doi.org/10.1007/s40123-025-01094-2

Katzman LR, Jeng BH. Management strategies for persistent epithelial defects of the cornea. 

Ljubimov AV, Saghizadeh M. Progress in corneal wound healing. 

Rodríguez Calvo-de-Mora M, Domínguez-Ruiz C, Barrero-Sojo F, et al. Autologous versus allogeneic versus umbilical cord sera for the treatment of severe dry eye disease: a double-blind randomized clinical trial. 

Sánchez-González JM, Alonso-Aliste F, Borroni D, et al. Plasma rich in growth factors (PRGF) in transepithelial photorefractive keratectomy (TPRK). 

A novel therapeutic strategy combining eyelid pressure patching with amniotic membrane tissue (AMT) has proven effective and safe for treating persistent corneal epithelial defects. Traditional management of these defects includes various treatments, but AMT offers advantages such as rapid re-epithelialization, inflammation reduction, and support for healing. A retrospective study of 144 eyes showed complete healing with single-layer AMT and improvement with three-layer AMT, with no reported pain or infection. This approach enhances corneal healing, reduces inflammation, and increases patient comfort, making it a promising option for ocular surface disease management.

Amniotic membrane tissue offers a number of advantages to patients.

Noelle Whitestone, MHA

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