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Rx Insider

Novel therapy for IOP reduction

How Vyzulta may help patients who have open-angle glaucoma or ocular hypertension.

My glaucoma practice may have my name on the door, but every member of my team is critical to our mission: helping our patients retain their vision so they can lead fulfilling lives. It is important that my staff is aware of novel medical therapies as they come into our practice. That way, when patient issues come to the attention of the staff — whether patients are struggling with complicated drop regimens, not reaching target intraocular pressure (IOP), not tolerating therapies, or simply curious about additional treatments — staff know to say, “Ask the doctor. There are other medications that may treat your glaucoma.”

In this article, I will describe latanoprostene bunod ophthalmic solution 0.024% (Vyzulta, Bausch + Lomb).

What the research tells us

Vyzulta is available for IOP reduction in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).1 It is a single molecule metabolized into two moieties — the prostaglandin analog (PGA) latanoprost acid and butanediol mononitrate, which releases gaseous nitric oxide (NO).2 This allows for a dual mechanism of action, enhancing both trabecular and uveoscleral aqueous outflow.2 In LUNAR, a six-month phase 3 trial of OAG/OHT patients, IOP reduction with Vyzulta dosed once daily at night was noninferior to that with timolol 0.5% dosed twice daily.3 In a 12-month phase 3 trial of OAG/OHT patients (APOLLO), IOP reduction with Vyzulta dosed once daily at night was superior to timolol 0.5% dosed twice daily.4 And, in a phase 2, 29-day dose-ranging study of OAG/OHT patients, Vyzulta led to an IOP reduction of 9 mm Hg from baseline.5 In clinical studies of subjects with OAG or OHT, Vyzulta showed substantial IOP-lowering efficacy and an acceptable safety profile.1

The role of nitric oxide

The NO-releasing aspect of Vyzulta makes it novel among IOP-lowering medications. NO is synthesized in tissues throughout the body; in the eye, endogenous NO is thought to play an important role in regulating IOP.2 In glaucomatous eyes, however, ocular NO levels are reduced relative to normal eyes.2,6 The NO released by Vyzulta facilitates aqueous outflow via the trabecular meshwork, the primary outflow pathway in the eye.2

Product Profile

Vyzulta (latanoprostene bunod ophthalmic solution) 0.024%

Indication:

Reduction of 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%).

Full prescribing information is available at www.vyzulta.com .

Effective IOP control

Vyzulta is dosed once daily in the evening. While the unopened bottle should be kept refrigerated, once opened, it can be kept without refrigeration for up to eight weeks.1 Patients who are not responding to treatment with another IOP-lowering agent may benefit from moving to Vyzulta for additional IOP-lowering. I also frequently turn to Vyzulta for first-line treatment of OAG or OHT. (Please see “Important Safety Information,” on p. 40).

Indeed, thus far in my practice, prescribing Vyzulta has resulted in effective IOP control across a range of adult patient types, ages, starting IOP levels, and stages of disease. Recently, I prescribed Vyzulta to a 55-year old patient with newly diagnosed glaucoma, high IOP, and a very busy lifestyle on track to undergo selective laser trabeculoplasty. Over the ensuing months, given the amount of his IOP lowering, we reconsidered his plan for procedural intervention.

Stories such as these buoy my staff and me and highlight the rewards of providing care to our patients. When the whole eyecare team projects confidence and enthusiasm around innovative treatments, patients notice. OP

REFERENCES:

  1. Vyzulta Prescribing Information. June 2018. Bausch & Lomb Incorporated.
  2. Cavet ME, DeCory HH. The role of nitric oxide in the intraocular pressure lowering efficacy of latanoprostene bunod: review of nonclinical studies. J Ocul Pharmacol Ther. 2018;34:52-60.
  3. Medeiros FA, Martin KR, Peace J, et al. Comparison of latanoprostene bunod 0.024% and timolol maleate 0.5% in open-angle glaucoma or ocular hypertension: the LUNAR study. Am J Ophthalmol. 2016;168:250-9.
  4. Weinreb RN, Scassellati Sforzolini B, Vittitow J, et al. Latanoprostene bunod 0.024% versus timolol maleate 0.5% in subjects with open-angle glaucoma or ocular hypertension: The APOLLO study. Ophthalmology. 2016;123(5):965-73.
  5. Weinreb RN, Ong T, Scassellati Sforzolini B, et al; VOYAGER study group. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. 2015;99(6):738-45.
  6. Doganay S, Evereklioglu C, Turkoz Y, et al. Decreased nitric oxide production in primary open-angle glaucoma. Eur J Ophthalmol. 2002;12:44-8.