Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery

Tyson, S.; Bafna, Shamik; Gira, Joseph; Goldberg, Damien F.; Jones, Jason J.; Jones, Michael P.; Kim, Janet K; Martel, Joseph M.; Nordlund, Michael L.; Piovanetti-Perez, Ian K; Singh, Inder Paul; Metzinger, Jamie Lynne; Mulani, Deepa; Sane, Swati; Talamo, Jonathan H.; Goldstein, Michael H.

doi:10.1016/j.jcrs.2018.09.023

Cited by 53 publications

(98 citation statements)

References 13 publications

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“…The therapeutic efficacy of the dexamethasone intracanalicular insert for the treatment of post-surgical ocular pain and inflammation was demonstrated in three randomized, double-blind, phase III trials [OTX-13-002 (n = 247) [12], OTX-14-003 (n = 241) [12] and OTX-15-003 (n = 438) [13]; Fig. 1].…”

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

“…Patients were required to have a predicted post-surgical Snellen visual acuity of 20/200 or better in both eyes. Key exclusion criteria included corneal or retinal surgery or procedure within the previous 6 months or planned during the trial period, pre-existing ocular pain, macular disease (or oedema in OTX-13-002 and OTX-14-003), presence of ocular inflammation, history of or pharmaceutical treatment for glaucoma or ocular hypertension and spikes in intraocular pressure (IOP) in either eye [12,13]. The use of topical non-steroidal anti-inflammatory drugs (NSAIDs) was restricted to rescue therapy at the discretion of the investigator, however, the use of rescue medication was considered as treatment failure.…”

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

“…The use of topical non-steroidal anti-inflammatory drugs (NSAIDs) was restricted to rescue therapy at the discretion of the investigator, however, the use of rescue medication was considered as treatment failure. Systemic NSAIDs were permitted [12], but were restricted to 375 mg/day in OTX-15-003 [13]. The mean age of patients was 67.3-69.9 years across all treatment and placebo groups in the phase III trials, 48.8-62.8% of patients were female [12,13] and 31.5% of patients received cataract surgery for their second eye [15].…”

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

“…The proportion of patients with the absence of AC cells on day 14 (co-primary endpoint) was significantly higher in the dexamethasone treatment group in Fig. 1 Design of phase III trials (OTX-13-002 [12], OTX-14-003 [12] and OTX-15-003 [13]) evaluating the efficacy of the dexamethasone intracanalicular insert in post-surgical ocular pain and inflammation as assessed by the absence of AC cells, with the proportion of patients achieving an absence of pain or AC cells reported in the animated figure (available online). Dotted outlines indicate follow-up visits if the insert is detected on day 60.…”

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

“…*p ≤ 0.05 vs placebo in the respective trial. AC anterior chamber comparison to the placebo group in two of three trials (Table 2) [12,13].…”

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

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Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation

Lee

Blair

2020

Drugs

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Dextenza ® , an intracanalicular insert that is placed into the lower punctal opening of the eye, gradually releases dexamethasone for up to 30 days to alleviate pain and inflammation associated with ophthalmic surgery. A significantly higher proportion of patients treated with the dexamethasone intracanalicular insert than with the placebo insert had no pain at day 8 (co-primary endpoint, 7 days post-operation) across three pivotal phase III trials, and the inflammation co-primary endpoint (absence of anterior chamber cells) at day 14 (13 days post-operation) was met in two of three trials. Overall, the dexamethasone intracanalicular insert was effective and generally well tolerated for the treatment of post-surgical ocular pain and inflammation following cataract surgery. As low patient adherence is an issue for topical ophthalmic anti-inflammatory medications, the convenience (ease of insertion, single application with no patient input and typically no removal required) of the dexamethasone intracanalicular insert makes it a promising emerging option for the treatment of ocular inflammation and pain following ophthalmic surgery.

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Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

“…*p ≤ 0.05 vs placebo in the respective trial. AC anterior chamber comparison to the placebo group in two of three trials (Table 2) [12,13].…”

Section: Therapeutic Efficacy Of the Dexamethasone Insertmentioning

confidence: 99%

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Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation

Lee

Blair

2020

Drugs

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Use and Cost of Sustained-Release Corticosteroids for Cataract Surgery Under the Medicare Pass-Through Program

et al. 2023

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ImportanceSustained-release corticosteroids offer the potential of improved compliance and greater patient convenience for anti-inflammatory treatment after cataract surgery. However, they are substantially more expensive than postoperative corticosteroid eye drops, which have historically been standard care.ObjectiveTo examine the use and cost of sustained-release corticosteroids in patients with Medicare who underwent cataract surgery in the US during the temporary pass-through reimbursement program period.Design, Setting, and ParticipantsThis cross-sectional study examined Medicare fee-for-service (FFS) claims from beneficiaries with at least 12 continuous months of Medicare enrollment who underwent at least 1 cataract surgery from March 2019 through December 2021. Patients younger than 65 years, those with missing demographic information, those who had more than 1 cataract surgery on each eye, and those who received more than 1 corticosteroid on the day of surgery were excluded. Cataract surgeries with concurrent use of dexamethasone intraocular suspension 9% or dexamethasone ophthalmic insert were identified. Information on surgeon demographic characteristics and costs of surgery and drugs were extracted. Data were analyzed from June 15 to December 4, 2022.ExposureUse of dexamethasone intraocular suspension 9% or dexamethasone ophthalmic insert during cataract surgery.Main Outcome MeasuresUtilization rate and cost of dexamethasone intraocular suspension 9% and dexamethasone ophthalmic insert among Medicare FFS beneficiaries who underwent cataract surgery.ResultsA total of 4 252 532 cataract surgeries in Medicare FFS beneficiaries (mean [SD] age, 74.8 [5.8] years; 1 730 811 male [40.7%] and 2 521 721 female [59.3%]) were performed by 12 284 ophthalmologists (8876 male [72.3%], 2877 female [23.4%], and 531 sex unknown [4.3%]). In all, 34 627 beneficiaries (0.8%) received dexamethasone intraocular suspension 9% and 73 430 (1.7%) received a dexamethasone ophthalmic insert; the use of both drugs increased over the study period. The mean (SD) Medicare allowed charges for dexamethasone intraocular suspension 9% and dexamethasone ophthalmic insert were $531.47 ($141.52) and $538.49 ($63.79), respectively.Conclusions and RelevanceDespite offering the potential of improved compliance and greater patient convenience, findings of this study suggest that sustained-release corticosteroid use during cataract surgery was low and associated with cost increases to the health care system vs conventional postoperative eye drops. As these new products must be priced high enough to qualify for the Medicare pass-through program, unreasonable cost may have been a deterrent to their use, suggesting that the current Medicare reimbursement rules may not be appropriate for sustained-release postoperative corticosteroids in cataract surgery.

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Liposomal drug delivery system for anti-inflammatory treatment after cataract surgery: a phase I/II clinical trial

Wong

Metselaar

et al. 2021

Drug Deliv. and Transl. Res.

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Liposomes as a drug delivery system may overcome the problems associated with non-compliance to eyedrops and inadequate control of inflammation after cataract surgery. We evaluated the safety and efficacy of a single subconjunctival injection of liposomal prednisolone phosphate (LPP) for the treatment of post-cataract surgery inflammation. This is a phase I/II, openlabel non-comparative interventional trial of patients undergoing cataract surgery. All patients received a single injection of subconjunctival LPP intraoperatively. The primary outcome measure was the proportion of eyes with an anterior chamber cell count of 0 at postoperative month 1. Ocular and non-ocular adverse events, including elevated intraocular pressure, rebound iritis and pseudophakic macular edema were monitored. Five patients were enrolled in this study. The mean age was 66.6 ± 6.2 and 4 (80%) were male. The proportion of patients with AC cell grading of 0 was 0%, 80%, 80%, and 100% at day 1, week 1, month 1, and month 2 after cataract surgery, respectively. Mean laser flare photometry readings were significantly elevated at week 1 after cataract surgery (48.8 ± 18.9, p = 0.03) compared with baseline, decreasing to 25.8 ± 9.2 (p = 0.04) at month 1 and returned to baseline by month 2 (10.9 ± 5.1, p = 1.0). No ocular or non-ocular adverse events were observed. Liposomal prednisolone phosphate, administered as a single subconjunctival injection intraoperatively, can be a safe and effective treatment for post-cataract surgery inflammation. The delivery of steroids with a liposomal drug delivery system could potentially replace eyedrops as anti-inflammatory therapy following cataract surgery.

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Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery

Cited by 53 publications

References 13 publications

Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation

Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation

Use and Cost of Sustained-Release Corticosteroids for Cataract Surgery Under the Medicare Pass-Through Program

Liposomal drug delivery system for anti-inflammatory treatment after cataract surgery: a phase I/II clinical trial

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