Sanaregen™ Vision Therapeutics Receives FDA Clearance for Clinical Trial to Treat Retinal Degeneration

NASHVILLE, Tenn.--(BUSINESS WIRE)--Sanaregen Vision Therapeutics, a clinical-stage regenerative medicine company, today announced clearance by the U.S. Food and Drug Administration to conduct a Phase I/II clinical trial for SVT-001, its investigational cell therapy.

The trial will assess safety and effectiveness of SVT-001 to improve retinal function and restore vision in individuals with Familial Drusen, an inherited form of macular degeneration. There are currently no approved disease-modifying treatments for the condition.

“This is a pivotal moment not only for our company, but for the families that have endured generations of early-onset blindness,” said Anthony Oliva, Ph.D., Chief Scientific Officer and co-founder. “We believe SVT-001 provides true hope to prevent the almost inevitable vision loss caused by this devastating condition that has largely been overlooked.”

Doug Oliver, President and co-founder, reflects on forwarding SVT-001 into clinical trials. “This represents nearly a decade of advocacy, scientific groundwork, regulatory cooperation and mission focus.” Oliver, a global award-winning patient advocate who has Familial Drusen, is known for his personal experience of vision recovery following cell-based therapy, which fueled his work with lawmakers to craft the 21^st Century Cures Act. “I believe this cell therapy will ultimately be proven safe, easily administered, and highly effective at preventing and reversing vision loss. It’s a very exciting time for our company and patients alike.”

Rare Disease with Broader Market Implications

Familial Drusen is an aggressive retinal degeneration disorder characterized by early-age accumulation of waxy pathological deposits beneath the retina, called drusen. Many affected patients begin experiencing progressive central blindness around 40 years of age. While distinct from the much more prevalent disorder, dry age-related macular degeneration (AMD), the pathological similarities, including drusen accumulation and geographic atrophy, positions SVT-001 as a promising therapeutic candidate for AMD.

About Sanaregen Vision Therapeutics, Inc.

Sanaregen Vision Therapeutics is a U.S.-based biopharma company committed to developing affordable, accessible, and innovative cell-based therapies for degenerative retinal diseases.

Forward-Looking Statements

This release contains forward-looking statements subject to risks and uncertainties. Actual results may differ materially. We undertake no obligation to update this information, which speaks only as of this date, except as required by law.