ISTH0036 Shows Promise in Wet AMD and DME Trial

By Pune Media On May 13, 2025

Isarna Therapeutics presented the final results from its Phase 2 BETTER trial on May 6 at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, highlighting the clinical potential of its investigational therapy ISTH0036 in patients with wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

Targeting Retinal Fibrosis with ISTH0036

ISTH0036 is a selective TGF-β2-blocking antisense oligonucleotide designed to address retinal fibrosis, a key contributor to disease progression in wet AMD and DME that is not targeted by current anti-VEGF therapies.

“This is a promising advance toward transforming care for patients facing progressive vision loss despite optimal standard therapy,” said Prof. Marion R. Munk, Chief Medical Officer of Isarna Therapeutics. “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.”

Positive Visual and Anatomical Outcomes

The international multicenter study, conducted at sites in Austria and India, evaluated ISTH0036 in both treatment-naïve and anti-VEGF–pretreated but inactive patients. Patients received intravitreal injections every 8 weeks (Q8W).

Key findings included:

• Stable or improved best-corrected visual acuity (BCVA)

• Reduction in central retinal thickness (CRT) across all patient groups

• In wet AMD eyes with fibrosis-associated hyperreflective material (HRM), a significant reduction in HRM volume was observed with ISTH0036, in contrast to volume increases in fellow eyes treated with standard anti-VEGF therapy

• In DME patients, ISTH0036 led to a decrease in intraretinal fluid volume in both treatment-naïve and previously treated eyes

Additionally, intraocular pressure remained stable, and the treatment was well tolerated.

Moving Toward Pivotal Trials

Isarna now plans to engage with regulatory agencies in the U.S. and EU to discuss the BETTER trial findings and align on the development strategy for ISTH0036. The next steps include advancing the candidate into Phase 2b/Phase 3 pivotal clinical studies.

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