Dexamethasone Sustained-Release Intracanalicular Insert for Control of Postoperative Inflammation After Pars Plana Vitrectomy

Abstract

Purpose

To evaluate the safety and efficacy of a dexamethasone sustained-release intracanalicular insert (DII) (Dextenza^® Ocular Therapeutix, Inc., Bedford, MA) for control of inflammation and pain after pars plana vitrectomy (PPV) compared to standard topical steroid therapy.

Methods

Retrospective, case-matched comparison of consecutive patients undergoing PPV. Control patients were matched by diagnosis and procedure performed. The primary outcome was the proportion of patients with complete anterior chamber cell clearance (ACCC) at postoperative day 7. Secondary outcomes included proportion developing intraocular pressure (IOP) >25 mmHg, change in mean optical coherence tomography central foveal thickness (OCT CFT), and proportion developing cystoid macular edema (CME) on qualitative analysis of OCT.

Results

The DII group had a statistically significant higher rate of complete ACCC compared to the topical steroid group (65% versus 35%, respectively, with p=0.01). No eyes had IOP >25 mmHg in the DII, compared to 2 eyes in the topical steroid group (not statistically significant). Overall, mean OCT CFT decreased in both groups; one patient had CME in the DII group, as compared to three in the topical steroid group (not statistically significant).

Conclusion

The dexamethasone intracanalicular insert provided excellent safety and efficacy in control of postoperative inflammation following PPV in this retrospective case-matched study.

Keywords:

• dexamethasone intracanalicular insert
• sustained-release drug delivery
• pars plana vitrectomy
• postoperative inflammation
• PPV

Ethics Approval

The current study was approved by the Western Institutional Review Board. Due to the retrospective nature of the study, patient consent to review the data was waived by the Western IRB. The data was de-identified after collection to protect patient confidentiality and privacy. The study adhered to the principles of the Declaration of Helsinki.

Acknowledgments

Editorial support in the development of this manuscript was provided by Tony Realini, MD and funded by Ocular Therapeutix, Inc. in accordance with Good Publication Practice (GPP3) guidelines. Presented at the 2020 ASRS Annual Meeting, 2020 Retina Society Annual Meeting, and 2020 Euretina Meeting.

Author Contributions

The authors contributed to this work in the following ways:

1. Made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas.

2. Have drafted or written, or substantially revised or critically reviewed the article.

3. Have agreed on the journal to which the article will be submitted.

4. Reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage.

5. Agree to take responsibility and be accountable for the contents of the article.

Disclosure

Dr. Suñer is a consultant for Ocular Therapeutix, Alcon, Alimera, Allergan, Genentech, Novartis, and Regeneron. Dr. Peden is a consultant for Genentech. The authors report no other conflicts of interest in this work.

Additional information

Funding

The study was supported in part by an unrestricted research grant from Ocular Therapeutix, Inc. The supporting source had no involvement in study design, collection, analysis, and interpretation of data.