Intravitreal Dexamethasone Implant as a Sustained Release Drug Delivery Device for the Treatment of Ocular Diseases: A Comprehensive Review of the Literature

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Abstract

Drug delivery into the vitreous chamber remains a great challenge in the pharmaceutical industry due to the complex anatomy and physiology of the eye. Intravitreal injection is the mainstream route of drug administration to the posterior segment of the eye. The purpose of this review is to assess the current literature about the widening use of the intravitreal 0.7 mg dexamethasone (Dex) implant, and to provide a comprehensive collection of all the ocular disorders that benefit from Dex administration. Although anti-vascular endothelial growth-factors (VEGFs) have been largely indicated as a first-choice level, the Dex implant represents an important treatment option, especially in selected cases, such as vitrectomized eyes or patients in whom anti-VEGF failed or are contraindicated. In this article, the safety profile as well as the list of the possible complications related to intravitreal Dex injection are also discussed.

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Guidelines for the Management of Diabetic Macular Edema by the European Society of Retina Specialists (EURETINA)

Anat Loewenstein, Ramin Tadayoni, Michael Larsen … (2017)

Diabetic retinal disease is envisioned to become the plague of the coming decades with a steep increase of worldwide diabetes incidence followed by a substantial rise in retinal disease. Improvements in diagnostic and therapeutic care have to cope with this dilemma in a clinically and socioeconomically efficient manner. Laser treatment has found a less destructive competitor in pharmacological treatments. As a consequence of recent rigorous clinical trials, laser photocoagulation is no longer recommended for the treatment of diabetic macular edema (DME), and anti-vascular endothelial growth factor therapy has emerged as first-line therapy. Steroids have maintained a role in the management of chronically persistent DME. The paradigm shifts in therapy are accompanied by a substantial break-through in diagnostics. The following guidance for the management of DME has been composed from the best updated knowledge of leading experts in Europe and represents another volume in the series of EURETINA recommendations for the management of retinal disease.

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Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results.

Julia A Haller, Francesco Bandello, Rubens Belfort … (2011)

To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO). Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension. We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO. At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was 250 μm. The primary outcome for the open-label extension was safety; BCVA was also evaluated. At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a ≥ 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A ≥ 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively. Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression. Proprietary or commercial disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis.

Careen Y. Lowder, Rubens Belfort, Sue Lightman … (2011)

To evaluate the safety and efficacy of 2 doses of dexamethasone intravitreal implant (DEX implant) for treatment of noninfectious intermediate or posterior uveitis. In this 26-week trial, eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with a 0.7-mg DEX implant (n = 77), 0.35-mg DEX implant (n = 76), or sham procedure (n = 76). The main outcome measure was the proportion of eyes with a vitreous haze score of 0 at week 8. The proportion of eyes with a vitreous haze score of 0 at week 8 was 47% with the 0.7-mg DEX implant, 36% with the 0.35-mg DEX implant, and 12% with the sham (P .05 at any visit). The incidence of cataract reported in the phakic eyes was 9 of 62 (15%) with the 0.7-mg DEX implant, 6 of 51 (12%) with the 0.35-mg DEX implant, and 4 of 55 (7%) with the sham (P > .05). In patients with noninfectious intermediate or posterior uveitis, a single DEX implant significantly improved intraocular inflammation and visual acuity persisting for 6 months. Application to Clinical Practice Dexamethasone intravitreal implant may be used safely and effectively for treatment of intermediate and posterior uveitis. Trial Registration clinicaltrials.gov Identifier: NCT00333814.

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Journal ID (nlm-ta): Pharmaceutics

Journal ID (iso-abbrev): Pharmaceutics

Journal ID (publisher-id): pharmaceutics

Title: Pharmaceutics

Publisher: MDPI

ISSN (Electronic): 1999-4923

Publication date (Electronic): 26 July 2020

Publication date Collection: August 2020

Volume: 12

Issue: 8

Electronic Location Identifier: 703

Affiliations

[1 ]Department of Surgical Sciences, Eye Clinic, University of Cagliari, 09124 Cagliari, Italy

[2 ]Institute of Ophthalmology, University of Modena and Reggio Emilia, 41121 Modena, Italy; rodolfo.mastropasqua@ 123456unimore.it

[3 ]Department of Surgical and Biomedical Sciences, Section of Ophthalmology, University of Perugia, S. Maria della Misericordia Hospital, 06129 Perugia, Italy; marco.lupidi@ 123456ospedale.perugia.it (M.L.); alessio.cerquaglia@ 123456studenti.unipg.it (A.C.)

[4 ]Fondazione per la Macula Onlus, DINOMGI., University Eye Clinic, 16132 Genova, Italy

[5 ]Centre de l’Odéon, 113 Boulevard St Germain, 75006 Paris, France

[6 ]Department of Neurosciences, Psychology, Drug Research and Child Health, Eye Clinic, University of Florence, AOU Careggi, 50139 Florence, Italy; d.bacherini@ 123456unifi.it (D.B.); luciafinocchio@ 123456gmail.com (L.F.)

[7 ]Ophthalmology Unit, S. Orsola-Malpighi University Hospital, University of Bologna, 40138 Bologna, Italy; marco.pellegrini9@ 123456studio.unibo.it (M.P.); federico.bernabei2@ 123456studio.unibo.it (F.B.)

[8 ]Department of Ophthalmology, Hospital San Raffaele, University Vita Salute San Raffaele, 20132 Milan, Italy; enrico.borrelli@ 123456hsr.it (E.B.); sacconi.riccardo@ 123456hsr.it (R.S.)

[9 ]Department of Ophthalmology, University “Magna Graecia,” 88100 Catanzaro, Italy; adrianocarnevali@ 123456unicz.it (A.C.); giuseppe.giannaccare@ 123456unicz.it (G.G.)

[10 ]Department of Medicine and Science of Ageing, Ophthalmology Clinic, University “G. d’Annunzio” Chieti-Pescara, 66100 Chieti, Italy; rossella.daloisio@ 123456unich.it

[11 ]Moorfields Eye Hospital NHS Foundation Trust, London EC1V2PD, UK

[12 ]Fatebenefratelli-Oftalmico Hospital, ASST-Fatebenefratelli-Sacco, 63631 Milan, Italy; andrea.govetto@ 123456UHBristol.nhs.uk (A.G.); stefano.erba@ 123456asst-fbf-sacco.it (S.E.); giacinto.triolo@ 123456asst-fbf-sacco.it (G.T.)

[13 ]Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol BS12LX, UK

[14 ]Ophthalmology Complex Operative Unit, Campus Bio Medico University Hospital, 00128, Rome, Italy; a.dizazzo@ 123456unicampus.it

[15 ]Domus Nova Hospital, 48121 Ravenna, Italy; matteo.forlini@ 123456iss.sm

[16 ]University Eye Clinic, DINOGMI, Polyclinic Hospital San Martino IRCCS, 16132 Genoa, Italy; aldo.vagge@ 123456unige.it

Author notes

[* ]Correspondence: claudioiovino88@ 123456gmail.com ; Tel.: +39-070-609-2319

[†]

Member of the Young Ophthalmologists Reviews Study Group (YORSG).

Author information

Claudio Iovino https://orcid.org/0000-0003-1984-0555

Marco Lupidi https://orcid.org/0000-0002-6817-2488

Lucia Finocchio https://orcid.org/0000-0003-1986-045X

Giacinto Triolo https://orcid.org/0000-0001-7681-8069

Article

Publisher ID: pharmaceutics-12-00703

DOI: 10.3390/pharmaceutics12080703

PMC ID: 7466091

PubMed ID: 32722556

SO-VID: 5225786d-a1e0-432e-9bd1-fbc58dbd637a

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Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

Intravitreal Dexamethasone Implant as a Sustained Release Drug Delivery Device for the Treatment of Ocular Diseases: A Comprehensive Review of the Literature

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Most cited references 170

Guidelines for the Management of Diabetic Macular Edema by the European Society of Retina Specialists (EURETINA)

Dexamethasone intravitreal implant in patients with macular edema related to branch or central retinal vein occlusion twelve-month study results.

Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis.

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