Sanaregen Vision Therapeutics, a clinical-stage regenerative medicine company, on Tuesday announced US Food and Drug Administration (FDA) clearance to begin a Phase I/II clinical trial of SVT-001, its investigational cell therapy.

The trial will evaluate the safety and effectiveness of SVT-001 in improving retinal function and restoring vision in patients with Familial Drusen, an inherited form of macular degeneration.

Familial Drusen is an aggressive retinal degeneration disorder marked by early accumulation of drusen deposits beneath the retina, often leading to progressive central blindness around age 40. There are currently no approved disease-modifying treatments for this condition.

Although distinct from dry age-related macular degeneration (AMD), the pathological similarities, including drusen accumulation and geographic atrophy, suggest that SVT-001 could have broader therapeutic potential for AMD.