Isarna Therapeutics presented final positive results from its Phase II BETTER trial at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting on 6th May.
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Positive results concept.
Isarna’s chief medical officer, Prof. Marion R. Munk, shared data on ISTH0036, a selective TGF-β2-blocking antisense oligonucleotide, in patients with wet age-related macular degeneration (nAMD) and diabetic macular edema (DME). The study evaluated the potential of ISTH0036 to address retinal fibrosis, an unmet medical need not targeted by current anti-VEGF therapies.
In the international multicentre study, patients who received intravitreal injections of ISTH0036 every eight weeks (Q8W) experienced stable or improved best-corrected visual acuity (BCVA), along with meaningful anatomical improvements in the retina. All patient groups showed a reduction in central retinal thickness (CRT). Notably, eyes with nAMD and fibrosis-associated hyperreflective material (HRM) exhibited a significant decrease in HRM volume following ISTH0036 treatment, contrasting sharply with increases seen in fellow eyes receiving standard anti-VEGF therapy. In DME patients, ISTH0036 reduced intraretinal fluid volume in treatment-naïve and previously anti-VEGF–treated eyes. Intraocular pressure remained, and the treatment was well tolerated.
“The results from the BETTER trial underscore the potential of ISTH0036 as a first-in-class antifibrotic agent that directly targets TGF–β2–driven fibrosis—a key driver of disease progression in nAMD and DME,” said Prof. Marion R. Munk, CMO of Isarna Therapeutics. “This is a promising advance toward transforming care for patients facing progressive vision loss despite optimal standard therapy. Isarna’s next step will be to discuss the results and our development strategy with regulators in the US and EU to move ISTH0036 into Phase 2b/ Phase 3 pivotal clinical studies.”