Condition Watch: Dry Eye Relief

Pharmacy TimesMarch 2024
Volume 90
Issue 3

Perfluorohexyloctane Ophthalmic Solution Proves Efficacious in Chronic Dry Eye Disease

Researchers have found that perfluorohexyloctane ophthalmic solution (Miebo; Bausch + Lomb) could be an effective and well-tolerated treatment to provide long-term relief for individuals with chronic dry eye disease (DED). DED is a chronic inflammatory ocular surface disease that can create dryness, stinging, burning, grittiness, and episodes of blurred vision. DED can be either evaporative, stemming from a deficient tear film of the lipid layer, or aqueous, which occurs when the eye does not produce enough tears.

Close up of the red eye of a man affected by an infection, copy space - Image credit: lenblr |

Image credit: lenblr |

The FDA granted approval for the use of perfluorohexyloctane following data from the Gobi Study (NCT04139798) and Mojave Study (NCT04567329), both of which were multicenter, randomized, double-masked, saline-controlled trials. Both studies met their primary and symptom efficacy end points of change in baseline in total corneal fluorescein staining and eye dryness scores, with the agent providing relief for patients from day 15 to day 57. The new data come from the phase 3 multicenter, single-arm, open-label Kalahari Study (NCT04140227), an extension trial that tested perfluorohexyloctane in 208 individuals reported to have symptoms of DED connected with meibomian gland dysfunction. Participants include in the KALAHARI Study were treated with saline in the GOBI Study.

The results from KALAHARI showed improvement in total corneal fluorescein staining (tCFS) and visual analog scale (VAS) eye dryness. By week 4 of treatment, participants showed improvements in tCFS and VAS scores

Adverse events included blurred vision, allergic conjunctivitis, and increased lacrimation, which arose in 1.4% of patients.—Kennedy Ferruggia

FDA Approves New LASIK Device Teneo for Vision Correction Surgery

The FDA has approved the Teneo excimer laser platform (Bausch + Lomb), a new laser-assisted in situ keratomileusis (LASIK) device, for vision correction surgery for individuals with myopia and myopic astigmatism, according to a press release. Teneo offers unique features that have not been previously offered by excimer laser platforms.

According to the release, Teneo has an advanced eye tracker, operating at 1740 Hz, which is designed to ensure the laser ablation pattern is not negatively affected by the patient’s eye movement. This is 3 times faster than the speed of the laser’s repetition and helps achieve better postoperative outcomes. Furthermore, the device contains a laser that operates at 500 Hz, which is the fastest ablation time for all excimer lasers currently available in the United States, operating at approximately 1.2 seconds per diopter.

The device is indicated for the reduction or elimination of myopic astigmatism up to –10.00 D mean refraction spherical equivalent, with sphere between –1.00 D and cylinder between 0.00 and –3.00 D, in individuals 22 years or older who have had stable refraction within the last 12 months confirmed by clinical records. Additionally, the spherical and cylindrical portions of the manifest distance refraction should not have progressed at more than 0.50 D per year prior to the baseline examination in order for the patient to qualify, according to the press release.—Ashley Gallagher

Adalimumab Biosimilar Shows Efficacy in Noninfectious Uveitis

Uveitis is a condition involving the inflammation of the uveal tissues of the eye, including the iris, ciliary body, and choroid. It can be associated with marked visual morbidity and impairment.1

Investigators conducted a retrospective study evaluating the efficacy and safety of adalimumab originator to SB5, an adalimumab biosimilar for the treatment of patients with noninfectious uveitis (NIU). The retrospective data analysis involved 15 patients (29 eyes) with NIU. The researchers switched these patients from adalimumab originator to SB5, with a follow-up of 6 months or longer. The data included best-corrected visual acuity (BCVA, logMAR), intraocular pressure (IOP, mm Hg), anterior changer (AC) cell grade, anterior vitreous (AV) cell grade, vitreous haze grade, central macular thickness (CMT, μm), and macular volume (MV, mm3) before switching and then at 2, 4, and 6 months after switching.2

Researchers observed no significant differences in BCVA, AC and AV cell grades, and vitreous haze grades at 2, 4, and 6 months post vs before switching and no significant differences in CMT and MV at 2 and 6 months post switching. Additionally, no recurrence of uveitis occurred as defined by AC cell grade, vitreous haze, or BCVA.2Bragadeesh R. Iyer, PharmD, BCGP, CSP

Perfluorohexyloctane Ophthalmic Solution Proves Efficacious in Chronic Dry Eye Disease
Bausch + Lomb announces publication of MIEBO (perfluorohexyloctane ophthalmic solution) phase 3 extension trial data in Cornea. News release. Bausch + Lomb. News release. November 7, 2023. Accessed November 7, 2023.
FDA Approves New LASIK Device Teneo for Vision Correction Surgery
Bausch +Lomb receives FDA approval for Teneo excimer laser platform for myopia and myopic astigmatism LASIK vision correction surgery. News release. Bausch +Lomb Corporation. January 8, 2024. Accessed January 9, 2024.
Adalimumab Biosimilar Shows Efficacy in Noninfectious Uveitis
1. Joltikov KA, Lobo-Chan AM. Epidemiology and risk factors in non-infectious uveitis: a systematic review. Front Med (Lausanne). 2021;8:695904.doi:10.3389/fmed.2021.695904 Published 2021 Sep 10.
2. Song SH, Woo SJ. Efficacy and safety of switching from adalimumab originator to SB5, adalimumab biosimilar for noninfectious uveitis. Ocul Immunol Inflamm. Published online January 9, 2024.doi:10.1080/09273948.2023.2295544
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