Plasma Pharmacokinetic Parameters of Dexamethasone Following Administration of a Dexamethasone Intracanalicular Insert in Healthy Adults

Blizzard, Charles D; McLaurin, Eugene; Driscoll, Arthur; Silva, Fabiana Q; Vantipalli, Srilatha; Metzinger, Jamie Lynne; Goldstein, Michael H.

doi:10.2147/opth.s307194

Cited by 5 publications

(1 citation statement)

References 21 publications

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“…First, it provides short-term pulsed therapy with a diminishing dose over time to minimize complications related to IOP and cataract formation 54 , 55 and with minimal systemic absorption. 56 Second, it is preservative-free, which is important given the pro-inflammatory nature of preservatives in ophthalmic formulations and their adverse effects on ocular surface disease. 57 Third, its anti-inflammatory mechanism of action is complementary to that of thermal pulsation therapy, favoring additivity of efficacy.…”

Section: Discussionmentioning

confidence: 99%

Thermal Pulsation with or without Dexamethasone Intracanalicular Insert for Meibomian Gland Dysfunction: A Prospective, Masked Trial

Dierker¹,

Hauswirth²

2022

OPTH

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Significance Meibomian gland dysfunction (MGD) is among the most common causes of dry eye disease worldwide. Few studies have compared treatment options, and the basis for an evidentiary approach to MGD management is lacking. We have conducted a non-randomized trial evaluating the additive benefit of a recently developed therapy. Purpose To compare the efficacy of thermal pulsation therapy alone or combined with the dexamethasone intracanalicular insert (Dextenza) on the signs and symptoms of MGD. Methods This was a prospective, patient-masked, sham-controlled, non-randomized trial. All subjects underwent thermal pulsation therapy using the LipiFlow system. The dexamethasone intracanalicular insert was placed in the inferior canaliculus of the more symptomatic eye (DEX group), while sham punctal dilation of the fellow eye was performed to preserve patient masking (SHAM group). Key outcomes were improvement in meibum expressibility at 1, 4, and 12 weeks and patient treatment preference at week 12. Results Nineteen subjects underwent thermal pulsation therapy and received the DEX insert. Meibomian gland expressibility scores improved significantly in both groups at 1, 4, and 12 weeks, with significantly greater improvement in DEX eyes than SHAM eyes at 12 weeks ( P =0.027). Improvement from baseline in TBUT was significant at all time points in DEX eyes and only at week 4 in SHAM eyes, with significantly greater improvement in DEX eyes over SHAM eyes at week 12 ( P =0.028). Mean best-corrected visual acuity and intraocular pressure remained unchanged from baseline throughout follow-up in both groups, and no adverse events were noted. Combined therapy with DEX was preferred by 61% of subjects. Conclusion This study demonstrated a significant benefit of combining thermal pulsation therapy with the dexamethasone intracanalicular insert on signs of MGD including TBUT and meibomian gland expressibility score. Consequently, a majority of patients preferred combination therapy to thermal pulsation therapy alone.

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Section: Discussionmentioning

confidence: 99%

Thermal Pulsation with or without Dexamethasone Intracanalicular Insert for Meibomian Gland Dysfunction: A Prospective, Masked Trial

Dierker¹,

Hauswirth²

2022

OPTH

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Development of a biodegradable polymer-based implant to release dual drugs for post-operative management of cataract surgery

Subhash,

Nair,

Srinivas

et al. 2024

Drug Deliv. and Transl. Res.

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Cataract surgery is followed by post-operative eye drops for a duration of 4–6 weeks. The multitude of ocular barriers, coupled with the discomfort experienced by both the patient and their relatives in frequently administering eye drops, significantly undermines patient compliance, ultimately impeding the recovery of the patient. This study aimed to design and develop an ocular drug delivery system as an effort to achieve a drop-free post-operative care after cataract surgery. An implant was prepared containing a biodegradable polymer Poly-lactic-co-glycolic acid (PLGA), Dexamethasone (DEX) as an anti-inflammatory drug, and Moxifloxacin(MOX) as an antibiotic. Implant characterization and drug loading analysis were conducted. In vitro drug release profile showed that the release of the two drugs are correlated with the clinical prescription for post operative eye drops. In vivo study was conducted on New Zealand albino rabbits where one eye underwent cataract surgery, and the drug delivery implant was inserted into the capsular bag after placement of the synthetic intraocular lens (IOL). Borderline increase in the intraocular pressure (IOP) was noted in the test sample group. Slit-lamp observations revealed no significant anterior chamber reaction in all study groups. Histopathology study of the operated eye revealed no significant pathology in the test samples. This work aims at developing the intra ocular drug delivery implant which will replace the post-operative eye drops and help the patient with the post-operative hassle of eye drops. Graphical abstract (created using BioRender.com)

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Topical ocular drug delivery systems: Innovations for an unmet need

Yang

Lockwood

2022

Experimental Eye Research

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Plasma Pharmacokinetic Parameters of Dexamethasone Following Administration of a Dexamethasone Intracanalicular Insert in Healthy Adults

Cited by 5 publications

References 21 publications

Thermal Pulsation with or without Dexamethasone Intracanalicular Insert for Meibomian Gland Dysfunction: A Prospective, Masked Trial

Thermal Pulsation with or without Dexamethasone Intracanalicular Insert for Meibomian Gland Dysfunction: A Prospective, Masked Trial

Development of a biodegradable polymer-based implant to release dual drugs for post-operative management of cataract surgery

Topical ocular drug delivery systems: Innovations for an unmet need

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