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ABOUT XELPROS

Innovative delivery of latanoprost in a BAK-free formulation1,2

XELPROS is the first and only BAK-free latanoprost delivered with LIPIXELLE, a novel micelle microemulsion formulation.1,2

  • LIPIXELLE technology encapsulates latanoprost within polymer/castor oil micelles2
  • Allows for BAK-free delivery and improved solubility of latanoprost2
LIPIXELLE formulation in XELPROS

Following instillation2:

  • The micelles mix with the tear film
  • As the micelles migrate toward the ocular surface, they break apart, releasing latanoprost onto the ocular surface for easier penetration
  • Other components of the micelle structure (castor oil, polymer) then supplement both the lipid and aqueous layers of the tear film

THE PROVEN IOP-LOWERING POWER OF XELPROS1,2,a

In clinical trials, XELPROS demonstrated significant reductions in intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.1

  • The mean IOP-lowering effect was up to 6-8 mmHg in patients with mean baseline IOP of 23-26 mmHg1

Study CLR-08-01: Peak IOP-lowering effect (mmHg) for XELPROS and Xalatan®2

Proven efficacy in open-angle glaucoma

XELPROS demonstrated IOP-lowering power throughout the day (similar to Xalatan, branded latanoprost)2

aSTUDY DESIGN: The efficacy and safety of XELPROS were assessed in 2 randomized, active-controlled (vs Xalatan) clinical trials in patients with open-angle glaucoma or ocular hypertension. Study 1 (CLR-08-01) included 104 patients (53 received XELPROS) with IOP measured in the morning and evening over 4 weeks. Study 2 (CLR-09-12) included 578 patients (289 received XELPROS) with IOP measured at 8:00 am, 10:00 am, and 4:00 pm over 12 weeks. XELPROS was dosed once daily in the evening in both trials.2

INDICATIONS AND USAGE

XELPROS (latanoprost ophthalmic emulsion) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

XELPROS is contraindicated in patients with a known hypersensitivity to latanoprost, or any other ingredients in this product.

WARNINGS AND PRECAUTIONS

Pigmentation: XELPROS may cause changes to pigmented tissues. The most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as XELPROS is administered. After discontinuation of XELPROS, iris pigmentation is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.

Eyelash Changes: XELPROS may gradually change eyelashes and vellus hair in the treated eye, including increased length, thickness, pigmentation, and number of lashes. The changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation: XELPROS should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular Edema: XELPROS should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Herpetic Keratitis: XELPROS should be used with caution in patients with a history of herpetic keratitis. XELPROS should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.

Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.

Use with Contact Lenses: Contact lenses should be removed prior to administration of XELPROS and may be reinserted 15 minutes following administration.

ADVERSE REACTIONS

The most common ocular adverse reactions in clinical trials (incidence ≥5%) for XELPROS were eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.

DRUG INTERACTIONS

Precipitation may occur if drugs containing thimerosal are used concomitantly with XELPROS. If such drugs are used, they should be administered at least 5 minutes apart.

Please see the Full Prescribing Information.

BAK=benzalkonium chloride.

References: 1. XELPROS [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2018. 2. Data on file. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.