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07 May, 2025
Isarna Therapeutics presented final positive results from its Phase 2 BETTER trial at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting on May 6. The data, delivered by Isarna’s Chief Medical Officer, Professor Marion R. Munk, highlighted the potential of ISTH0036, a selective antisense oligonucleotide targeting TGF-β2, in patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The study investigated the antifibrotic therapy’s ability to address retinal fibrosis—an unmet need not adequately targeted by existing anti-VEGF treatments. Conducted across multiple international centers, the trial demonstrated that patients receiving intravitreal ISTH0036 injections every eight weeks (Q8W) maintained or improved best-corrected visual acuity (BCVA), along with meaningful anatomical improvements.
Across all treatment groups, a reduction in central retinal thickness (CRT) was observed. Particularly noteworthy were findings in nAMD patients with fibrosis-associated hyperreflective material (HRM), where ISTH0036 significantly reduced HRM volume, in contrast to volume increases in fellow eyes treated with standard anti-VEGF therapy. In DME patients, ISTH0036 led to reductions in intraretinal fluid volume in both treatment-naïve and previously anti-VEGF–treated eyes. The therapy was well tolerated, and intraocular pressure remained stable throughout the study.
Professor Munk emphasized that the BETTER trial results reinforce ISTH0036’s potential as a first-in-class antifibrotic agent specifically targeting TGF-β2-driven fibrosis—a key contributor to disease progression in both nAMD and DME. She noted that these findings represent a promising step toward improving outcomes for patients who continue to lose vision despite standard therapies. Isarna Therapeutics plans to engage with regulatory authorities in the U.S. and Europe to advance ISTH0036 into Phase 2b/Phase 3 pivotal clinical development.