A1 Diagnosis

Blood-based AMD risk stratification for ophthalmology practices

Emerging Treatment Landscape Alignment

Drugs targeting early/intermediate AMD — Ophthalmologist-first strategy — March 2026

Tier 1 Directly Targeting Early / Intermediate AMD 25% of AMD cases missed at dilated eye exam (Neely et al., JAMA Ophthalmology 2017) — A1 closes the diagnostic gap
Drug Sponsor Phase Route Enrollment Criteria Why A1 Diagnosis Matters
Iptacopan Novartis Phase 2 Oral Early/iAMD in study eye; requires wet AMD in fellow eye; high-risk OCT features; age 50+ Trial uses wet AMD in fellow eye as a workaround to find high-risk patients. A1 blood test could identify high-risk early AMD patients directly, expanding the eligible pool beyond this restrictive criterion.
Risuteganib Allegro Ophthalmics Phase 2a Complete Intravitreal Intermediate dry AMD; OCT threshold screening (EZ and photoreceptor layer thickness); SPA granted, Phase 2b/3 not yet started Phase 2b/3 pivotal trial needs to enroll intermediate AMD patients. A1 could help ophthalmologists identify and refer candidates who might otherwise be missed (25% miss rate at eye exams).
Ocustatin Drusolv Therapeutics Pre-Phase 2 Oral Intermediate AMD with soft lipid-like drusen; 300-patient Phase 2 planned; IND in preparation Small company (BrightFocus-funded) needs to find 300 intermediate AMD patients with drusen for Phase 2. A1 could accelerate enrollment by identifying candidates from ophthalmology practices.
Xiflam InflammX / B+L Phase 2 Planned Oral Intermediate AMD (iAMD); early stage prior to vision loss; iAMD trial initiating (active Phase 2 is for DME) Oral drug treating both eyes — ideal for asymptomatic iAMD patients. A1 blood biomarkers (complement, inflammation) could help stratify which patients are most likely to respond.
Valeda PBM Alcon FDA Authorized Light Early/intermediate dry AMD; drusen ≥63µm on imaging; BCVA 20/32–20/100; no wet AMD or central GA Patients are identified via standard imaging. However, most intermediate AMD patients are asymptomatic and never visit an ophthalmologist. A1 could flag high-risk individuals who should be referred for imaging.
ALG-1007 Allegro Ophthalmics Development Eye Drops Not yet defined for AMD (Phase 2 completed for dry eye disease only) Too early to determine. AMD-specific development has not started; enrollment criteria not yet defined.
Undisclosed OphtiMed Rx Preclinical TBD Early/intermediate dry AMD; criteria TBD; first-in-human planned mid-2026 Too early to determine. Preclinical stage with no published enrollment criteria yet.
IKAR-003 Ikarovec Preclinical Intravitreal Gene Therapy Intermediate AMD; designed to prevent progression to GA or wet AMD; VectorBuilder capsid deal Jan 2026 Too early to determine. Preclinical with lead program (IKAR-001 for GA) targeting clinical trials late 2026.
👁 The diagnostic gap in ophthalmology: 25% of AMD cases are missed during dilated eye exams (Neely et al., JAMA Ophthalmology 2017) — both ophthalmologists and optometrists miss at equal rates. Among missed cases, 30% had large drusen consistent with intermediate AMD. A1 Diagnosis provides a complementary blood-based risk stratification tool that helps eye care providers catch what imaging alone misses and prioritize high-risk patients for closer monitoring.
25%
AMD missed at eye exam
5
Drugs A1 clearly helps
0
Blood-based Dx exist