regulatory
confidence high
sentiment positive
materiality 0.85
Glaukos receives FDA approval for iDose TR; 2024 revenue guidance $350-$360M
GLAUKOS Corp
- FDA approved iDose TR (travoprost intracameral implant) for reducing IOP in OHT or OAG; launch expected late Q1 2024.
- Phase 3 trials randomized 1,150 subjects; iDose TR showed non-inferiority to timolol at 3 months (IOP reduction 6.6-8.4 mmHg).
- 81% of iDose TR subjects were free of topical IOP-lowering medications at 12 months; 98% subject retention at 12 months.
- Wholesale acquisition cost set at $13,950 per implant; Glaukos launches iDose Your Dose charitable donation initiative.
- Reaffirms 2023 net sales guidance of $307-$310M; introduces 2024 preliminary guidance of $350-$360M.