The Ocular Hypertension Treatment Study

OHTS was a long-term, multiphase clinical study to compare the onset of glaucoma in ocular hypertension (OHT) patients who received early topical glaucoma medication with those who did not.1

  • Began in 1994 and analyzed 20 years of patient follow-up data2
  • Included patients with ocular hypertension, defined as an IOP ≥24 mmHg in at least 1 eye, but no evidence of glaucomatous damage at baseline3

Patients were randomized to one of 2 groups1:

  • One group began receiving topical glaucoma medication at the beginning of the study
  • The other group received no glaucoma medication for the first 7.5 years, after which they received treatment

Lower rate of POAG

Patients with OHT who received early treatment had a 60% lower 5-year risk of developing POAG, compared with patients who received no treatment.2

A lower incidence of POAG was observed in the early-treatment group throughout 20 years of follow-up.3

OHT treatment goals

At the start of OHTS, a target IOP reduction of 20% from baseline was chosen. This was not considered an ideal target but was based on what was believed to be achievable with topical medications available at the time.1 However, according to AAO, if a patient’s baseline IOP is especially high, a 20% reduction may be insufficient to reduce the risk of developing POAG.4

Patients to treat early

  • Higher-risk patients in particular may benefit from more frequent examinations and from early treatment.1
  • Treating OHT patients with a ≥10% 5-year risk of developing POAG (about one-third of the patients in OHTS) resulted in the greatest net health benefit while remaining cost-effective.5*

Risk factors for developing POAG6

To help identify those patients who may benefit most from early treatment, OHTS also set out to identify risk factors associated with the development of POAG.

The 5 primary risk factors found in the study were:

  • Older age
  • Thinner central corneal thickness
  • Larger cup-to-disk ratio
  • Higher pattern standard deviation on visual field
  • Higher IOP

*The analysis compared 4 treatment strategies: treat no one, treat everyone, treat those with ≥5% annual risk, and treat those with ≥2% annual risk (~10% 5-year risk). Treating those with ≥2% annual risk resulted in an ICER of $42,430/QALY, and its cost-effectiveness was established on an assumption of a willingness-to-pay threshold of $50,000-$100,000/QALY.5

ICER=incremental cost-effectiveness ratio; QALY=quality-adjusted life year.

INDICATION

VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

IMPORTANT SAFETY INFORMATION

  • Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent
  • Gradual changes to eyelashes, including increased length, increased thickness, and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuation
  • Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). VYZULTA should generally not be used in patients with active intraocular inflammation
  • Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema
  • There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patients
  • Contact lenses should be removed prior to the administration of VYZULTA and may be reinserted 15 minutes after administration
  • Most common ocular adverse reactions with incidence ≥2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%)

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References: 1. Kass MA, Gordon MO, Gao F, et al. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch Ophthalmol. 2010;128(3):276-87. 2. Kass MA, Heuer DK, Higginbotham EJ, et al. Assessment of cumulative incidence and severity of primary open-angle glaucoma among participants in the Ocular Hypertension Treatment Study after 20 years of follow-up. JAMA Ophthalmol. 2021;139(5):558–566. 3. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial Determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120(6):714-720, 829-830. 4. Primary Open-Angle Glaucoma Preferred Practice Pattern. American Academy of Ophthalmology; 2020. 5. Kymes SM, Kass MA, Anderson DR, Miller JP, Gordon MO; Ocular Hypertension Treatment Study Group (OHTS). Management of ocular hypertension: a cost-effectiveness approach from the Ocular Hypertension Treatment Study. Am J Ophthalmol. 2006;141:997-1008. 6. Gordon MO, Beiser JA, Brandt JD, et al. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120(6):714-720, 829-830.

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INDICATION

VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

IMPORTANT SAFETY INFORMATION

  • Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent