XLRP, RP, and wet AMD trial data slotted for presentation at EURETINA 2025

Ahead of the 2025 European Society of Retina Specialists (EURETINA) Congress and Retina Society Annual Scientific Meeting, three more companies have announced the presentation of new data.

Beacon Therapeutics Holdings Limited will present 9-month phase 2 DAWN and 36-month phase 2 SKYLINE trial data for laru-zova in patients with X-linked retinitis pigmentosa (XLRP)¹, Nanoscope Therapeutics will present 3-year REMAIN trial data for patients with retinitis pigmentosa (RP)², and Valitor will present new data for the company’s long-acting anti-VEGF drug candidate for the treatment of wet age-related macular degeneration (AMD).³

Beacon Therapeutics to present phase 2 DAWN trial and phase 2 SKYLINE trial data

Biotechnology company Beacon Therapeutics, focused on saving and restoring patient vision with blinding retinal disease, recently announced the company’s upcoming presentations during the 2025 EURETINA Congress being held September 4-7 in Paris, France.

The company will be presenting data from two phase 2 trials: the SKYLINE and DAWN studies, both assessing the use of laruparetigene zovaparvovec (laru-zova). Laru zova is a gene therapy treatment currently being evaluated for the treatment of patients with XLRP. Delivering a functional copy of the RPGRORF15 gene, the drug has the potential to restore the natural function of both rods and cones in XLRP.

Laru-zova has regenerative medicine advanced therapy (RMAT) and fast track designations from the US Food and Drug Administration (FDA), as well as priority medicines (PRIME) designation from the European Medicines Agency (EMA), innovative licensing and access pathway (ILAP) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and orphan drug designation (ODD) from both the FDA and EMA.¹

SKYLINE (NCT06333249) is an ongoing, fully enrolled, phase 2, randomized, controlled study investigating the safety, efficacy, and tolerability of laru-zova in 14 male patients with XLRP.¹ The primary endpoint is the proportion of response to microperimetry between the study and fellow eye at month 12.¹

DAWN (NCT06275620) is an ongoing, fully enrolled, phase 2, open-label study of laru-zova in the fellow eye of male patients with XLRP previously treated with an AAV vector-based gene therapy delivering the full-length RPGR protein.

Laru-zova is investigational and has not been approved by the FDA for use.

Beacon Therapeutics presentations at EURETINA 2025

Presentation title: Subretinal gene therapy laru-zova for X-linked retinitis pigmentosa (XLRP): Phase 2 DAWN trial, preliminary month 9+ results

• Presenter: Rajiv Anand, MD, FRCS, FRCOphth, Texas Retina Associates and Retina Foundation of the Southwest
• Date: September 4, 2025

Presentation title: Subretinal laru-zova gene therapy for XLRP: 36-month results of the randomized, controlled, multicenter Phase 2 SKYLINE trial

• Presenter: Paul Yang, MD, PhD, Chief, Payl H. Casey Ophthalmic Genetics Division, Casey Eye Institute, OHSU
• Date: September 4, 2025

Nanoscope Therapeutics to highlight MCO therapy platform

Focused on the development and commercialization of novel disease-agnostic therapies for patients with photoreceptor loss and vision impairment caused by retinal degeneration, Nanoscope announced it will be presenting new data on its RESTORE (NCT04945772) long-term follow-up study, REMAIN, at both the 2025 EURETINA Congress and the Retina Society Annual Meeting.²

RESTORE is a phase 2b multicenter, randomized, double-masked, sham-controlled clinical trial for RP.² Nanoscope has submitted a rolling BLA submission to the FDA for MCO-010. If approved, MCO-010 is a one-time, in-office injection as a potential standard of care for RP patients.

Nanoscope at 2025 EURETINA Congress

Title: REMAIN: 152-Week Extended Analysis from the RESTORE Study of MCO-010 Optogenetic Therapy for Retinitis Pigmentosa

Presenter: Jodi Mones, MD, PhD, Director, Institut de la Macula, Barcelona, Spain

Session title: Free Paper 11 – Inherited Retinal Diseases

Date: September 5

Time: 5:24 p.m. CEST

Nanoscope at 2025 Retina Society Annual Meeting

Title: REMAIN: 152-Week Extended Analysis from the MCO-010 Optogenetic Therapy for Retinitis Pigmentosa RESTORE Study

Presenter: Christine Kay, MD, Vitreoretinal Associates, Director of Clinical Research and Retinal Genetics

Session title: Genetic Diseases, Dystrophies, Degenerations

Date: September 10

Time: 3:44 p.m. CEST

Valitor to share new data on its wet AMD candidate, VLTR-559

Valitor announced the presentation of new data on VLTR-559, the company’s anti-VEGF therapy being evaluated for the treatment of wet AMD. Wesley Jackson, PhD, president and chief scientific officer of Valitor, will present the data at the Ophthalmology Futures Retina Forum and EURETINA Innovation Spotlight (EIS).³

VLTR-559 uses the company’s proprietary multivalent polymer (MVP) technology platform to enable reliable dosing twice yearly.³ The goal of the drug is to improve long-term efficacy. Preclinical studies have concluded VLTR-559 is consistent with approved anti-VEGF therapies and remained in the ocular tissues 3 to 4 times longer.³ Valitor is advancing VLTR-559 through IND-enabling activities with the goal of initiating a phase 1 clinical study in 2026.

Valitor at EURETINA 2025

• 2025 Ophthalmology Futures Retina Forum: Panel titled “The Future of Tyrosine Kinase Inhibitors & Other Adjunctive Agents for AMD: Exits or Bust?” at 11:50 a.m. CEST
• 2025 Ophthalmology Futures Retina Forum: Company presentation at 1:50 p.m. CEST
• EURETINA Innovation Spotlight (EIS): Presentation titled “Engineering a New Generation of Durable Ophthalmic Medicines Based on Multivalent Conjugation to Hyaluronic Acid” at 5:46 p.m. CEST

Reference:

1. Beacon Therapeutics Announces EURETINA 2025 Presentations on 9+-Month Phase 2 DAWN and 36-Month Phase 2 SKYLINE Trial Data for laru-zova in Patients with X-linked Retinitis Pigmentosa (XLRP) - Beacon Therapeutics. Beacon Therapeutics. Published August 21, 2025. Accessed August 29, 2025. https://www.beacontx.com/news-and-events/beacon-therapeutics-announces-euretina-2025-presentations-on-9-month-phase-2-dawn-and-36-month-phase-2-skyline-trial-data-for-laru-zova-in-patients-with-x-linked-retinitis-pigmentosa-xlrp/

2. PJ W. Nanoscope Announces Groundbreaking 3-Year REMAIN Trial Data for Patients with Retinitis Pigmentosa at 2025 Euretina Congress and Retina Society Annual Scientific Meeting - Nanoscope Therapeutics. Nanoscope Therapeutics. Published August 26, 2025. Accessed August 29, 2025. https://nanostherapeutics.com/2025/08/26/nanoscope-announces-groundbreaking-3-year-remain-trial-data-for-patients-with-retinitis-pigmentosa-at-2025-euretina-congress-and-retina-society-annual-scientific-meeting/

3. Press Release | Valitor. Valitorbio.com. Published August 21, 2025. Accessed August 29, 2025. https://www.valitorbio.com/news/press-releases/08-21-25/