secwatch.observer — SEC 8-K summary
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Issuer:     GLAUKOS Corp (GKOS)
CIK:        0001192448
Form:       8-K
Filed at:   2023-12-14T23:59:59+00:00
Accession:  0001104659-23-125872
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Glaukos receives FDA approval for iDose TR; 2024 revenue guidance $350-$360M
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1192448/000110465923125872/0001104659-23-125872-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1192448/000110465923125872/tm2332871d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-125872

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer