KB803 is an investigational redosable eye-drop gene therapy from Krystal Biotech for treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa. It is in Phase 3 IOLITE development and is designed to provide local type VII collagen production in the eye by delivering COL7A1 transgene copies to corneal epithelium. The program remains unapproved.
Krystal Biotech said IOLITE enrollment for KB803 is complete and it remains on track for KB803 and KB801 registrational data readouts in 2026. The company also reported FDA platform technology designations for KB407 and KB111 and continued VYJUVEK expansion.
Krystal Biotech is set to report fourth-quarter results with analysts expecting $1.58 a share on $106.16 million in revenue. Investors are watching Vyjuvek growth and pipeline programs including KB801, KB407 and KB707.
Krystal Biotech posted Q4 2025 net revenue of $107.1 million from Vyjuvek sales, with full-year revenue reaching $389.1 million. The company expanded to over 90 patients across Germany, France, and Japan while advancing its pipeline with new FDA designations.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07016750 |
A Study Comparing KB803 and Matched Placebo in Patients With Dystrophic Epidermolysis Bullosa |
RECRUITING | PHASE3 |
