Sep 24, 2020

FDA grants fast track designation to dry AMD gene therapy

The FDA has granted fast track designation to GT005 for the treatment of geographic atrophy secondary to dry age-related macular degeneration, according to a press release from Gyroscope Therapeutics.

The designation is for patients with specific mutations in the complement factor I gene and low levels of CFI protein in their blood. Enrollment is underway in the EXPLORE phase 2 study to evaluate GT005 in these patients.

“Dry AMD is a life-altering diagnosis, and there are currently no FDA-approved medicines available. Research suggests people with dry AMD who have certain CFI mutations that correlate with low CFI levels in the blood have a higher risk of developing AMD,” Nadia Waheed, MD, MPH, chief medical officer of Gyroscope Therapeutics, said in the release.

The company plans to begin a phase 2 trial in a broader group of patients before the end of the year.

Source: Healio

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