Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty

The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.

Start Date23 Nov 2021

Sponsor / Collaborator

Price Vision Group

[+1]

NCT04787471 / RecruitingPhase 2/3

Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection

The study objective is to assess safety and efficacy of photo-activation of riboflavin for treatment of corneal neovascularization with or without concomitant inflammation and/or infection.

Start Date03 May 2021

Sponsor / Collaborator

Price Vision Group

[+1]

NCT04141865 / TerminatedNot Applicable

Effect of Xen Implantation on the Aqueous Humor Proteome

The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma.

Start Date24 Oct 2019

Sponsor / Collaborator

Price Vision Group

100 Clinical Results associated with Price Vision Group

0 Patents (Medical) associated with Price Vision Group

138

Literatures (Medical) associated with Price Vision Group

01 Sep 2024·Diagnostic Microbiology and Infectious Disease

Utilizing confocal microscopy and topical natamycin in metarhizium keratitis of Caribbean origin

Article

Author: Relich, Ryan F ; Gang, Anjulie ; Lavik, John-Paul ; Chaleff, Alec

A 32-year-old contact lens-wearing man with recent travel history to the Caribbean was referred for a corneal infiltrate in the left eye that worsened following 1-week of steroid-antibiotic therapy. Corneal cultures were obtained and sent to our facility's clinical microbiology laboratory for analysis. Same-day in vivo confocal microscopy revealed fungal elements. Nucleic acid sequencing performed on the isolated determined it to be a member of the entomopathogenic genus Metarhizium. Over the course of 3 months, the patient's corneal infiltrate ultimately resolved following topical natamycin 5 % therapy. This is the first reported case to have originated in the Caribbean and to utilize in vivo confocal microscopy to aid diagnosis. Our case also supports previous reports of success with natamycin therapy in treatment of Metarhizium sp. keratitis.

01 Aug 2024·Cornea

Prospective Assessment of Loteprednol Etabonate 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty in Eyes With Fuchs Dystrophy

Article

Author: Feng, Matthew T ; Price, Marianne O ; Price, Francis W ; Gang, Anjulie

Purpose:The purpose of this study was to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension for prevention of immunologic rejection after Descemet membrane endothelial keratoplasty (DMEK).Methods:This prospective, open-label study enrolled 70 eyes of 70 participants without preexisting glaucoma 1 month after DMEK. Participants used topical loteprednol 0.25% 4 times daily for 2 months, tapered by 1 drop/month to once daily use, and continued use through 1 year after DMEK. Main outcomes were rate of intraocular pressure (IOP) elevation (defined as a relative increase of ≥10 mm Hg over the pretransplant IOP) and rate of initial allograft rejection episodes. The results were compared with historical data using the log-rank test.Results:All participants had Fuchs dystrophy, and 40 of 70 (57%) were female. None (0%) experienced an immunologic graft rejection episode, matching the previously reported efficacy of prednisolone acetate 1% suspension and loteprednol 0.5% gel (both 0% incidence). One study eye developed IOP elevation 3 months after DMEK (cumulative risk 1.5%). Compared with historical data, this was similar to the risk with loteprednol 0.5% gel (4%, P = 0.36) and significantly lower than the risk with prednisolone 1% suspension (18%, P = 0.0025). Two participants (3%) complained of instillation site discomfort, consistent with the 5% rate reported on package labeling.Conclusions:Loteprednol 0.25% suspension, approved for short-term treatment of dry eyes, effectively prevented immunologic rejection episodes with minimal risk of IOP elevation when used from 1 month until 12 months after DMEK in patients without preexisting glaucoma.

01 Apr 2024·Cornea

Innate Immune Cytokine Levels in Eyes With Late Endothelial Keratoplasty Failure

Article

Author: Dana, Reza ; Price, Marianne O ; Marzidovsek, Zala Luznik ; Price, Francis W

Purpose:The aim of this study was to compare aqueous humor cytokine levels in eyes with an initial endothelial keratoplasty (EK) that cleared and later decompensated versus control eyes.Methods:In this prospective case–control study, aqueous humor samples were collected under sterile conditions at the start of planned cataract or EK surgery in normal controls (n = 10), Fuchs dystrophy controls with no previous surgery (n = 10) or previous cataract surgery only (n = 10), eyes with Descemet membrane EK (DMEK) endothelial decompensation (n = 5), and eyes with Descemet stripping EK (DSEK) endothelial decompensation (n = 9). Cytokine levels were quantified with the LUNARIS Human 11-Plex Cytokine Kit and compared using the Kruskal–Wallis nonparametric test and post hoc Wilcoxon pairwise 2-sided multiple comparison test.Results:Levels of granulocyte-macrophage colony-stimulating factor, interferon gamma, interleukin (IL)-1β, IL-2, IL-4, IL-5, IL-10, IL-12p70, and tumor necrosis factorα did not differ significantly between groups. However, IL-6 was significantly increased in DSEK regraft eyes versus controls without previous ocular surgery. IL-8 was significantly increased in eyes with previous cataract or EK surgery versus eyes without previous surgery, and IL-8 was significantly increased in DSEK regraft eyes versus eyes with previous cataract surgery.Conclusions:The levels of innate immune cytokines IL-6 and IL-8 were elevated in the aqueous humor of eyes with failed DSEK, but not with failed DMEK. The differences between DSEK and DMEK may be related to the lower inherent immunogenicity of DMEK grafts and/or the more advanced stage of some of the DSEK graft failures at the time of diagnosis and treatment.

100 Deals associated with Price Vision Group

100 Translational Medicine associated with Price Vision Group

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Drug(Targets)	Indications	Global Highest Phase

Netarsudil Mesylate ( ROCK )	Fuchs' Endothelial Dystrophy More	Discontinued
Riboflavin 5'-Phosphate Sodium	Corneal Neovascularization More	Pending

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