Efficacy and Safety of Sustained Release Dexamethasone for the Treatment of Ocular Pain and Inflammation after Cataract Surgery: Results from Two Phase 3 Studies

Walters, Thomas R.; Bafna, Shamik; Vold, Steven D.; Wortz, Gary; Harton, Paul; Levenson, Jeffrey; Hovanesian, John; Mah, Francis S.; Gira, Joseph; Vroman, David T; Sampson, Reginald; Berdahl, John P.; Elmer, Thomas R.; Noecker, Robert J.

doi:10.4172/2155-9570.1000572

Cited by 41 publications

(93 citation statements)

References 27 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%

“…In the phase III trials, dexamethasone 0.4 mg or placebo intracanalicular inserts (i.e. an insert without dexamethasone) were placed during cataract surgery [9] Hydrolysis of the PEG polymer leads to degradation and clearance of the insert; removal via manual expression or irrigation with saline is not required [12] Ease of use Placement of the dexamethasone insert was deemed to be easy by investigators in 76.5% of pts across three phase III trials (n = 541) [36] and, when required, removal was reported to be easy or moderately easy in all removals of dexamethasone (n = 2) or placebo (n = 7) inserts [9] The fluorescent insert was easily visualized by investigators in 94.0% of pts on day 2 (day 1 post-operation) and 83.3% of pts in phase III trials by day 30 [9,36] on day 1 of the study (Fig. 2), and patients attended clinic visits up to day 120 in OTX-13-002, day 90 in OTX-14-003 and day 45 in OTX-15-003 ( Fig.…”

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%

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

Lee

Blair

2020

Drugs

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“…The steady levels of steroid medication in the tear film provided by the dexamethasone insert, as compared to short bursts of medication delivered via topical drop therapy, may also further explain the high patient-reported comfort scores. In the case of standard of care, initiation of corticosteroid drops after surgery may be delayed until a prescription is filled or due to recovery from anesthesia, while the dexamethasone insert is inserted at the completion of cataract surgery; this difference in time to initiation of therapy may be noteworthy as well, as pain relief in the dexamethasone insert clinical trials was found to be both rapid and pronounced 5. In aggregate, these seemingly minor differences in product profile may amount to major differences in outcomes from the patient perspective.…”

Section: Discussionmentioning

confidence: 99%

“…A sustained release hydrogel intracanalicular insert containing 0.4 mg of dexamethasone insert (Dextenza™; Ocular Therapeutix, Inc., Bedford, MA, USA) is currently in development for the treatment of ocular inflammation and pain following cataract surgery 5. It is a fluorescent yellow, 3 mm cylindrical-shaped preservative-free drug product.…”

Section: Introductionmentioning

confidence: 99%

“…A combination of objective and subjective measures (anterior chamber cells using the Standardization of Uveitis Nomenclature criteria, and a 10-point pain scale) was collected to evaluate the proportion of patients with an absence of cells in the anterior chamber and the proportion of patients with an absence of pain following surgery 5. A significantly greater percentage of patients receiving the sustained release dexamethasone insert were found to be free of ocular pain (score of 0) at 8 days after surgery in both studies (Study 1, 80.4% [131/164] vs 43.4% [36/83], P <0.0001; Study 2, 77.5% [124/161] vs 58.8% [47/80], P =0.0025), and a greater percentage of patients were found to have no inflammation (defined as the absence of anterior chamber cells) at day 14 in the first study (33.1% [54/164] vs 14.5% [12/83], P =0.0018); however, in the second study, this difference did not achieve statistical significance (39.4% [63/161] vs 31.3% [25/80], P =0.2182) 5. Despite missing the primary end point for inflammation in one study, other clinical assessments of inflammation, mean anterior chamber cell score, and absence of anterior chamber flare, which were collected and analyzed as secondary end points, supported the anti-inflammatory efficacy of the dexamethasone insert 5.…”

Section: Introductionmentioning

confidence: 99%

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Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza<sup>TM</sup>): results of a qualitative survey

Gira¹,

Sampson²,

Silverstein

et al. 2017

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PurposeThe purpose of this study is to evaluate the patient experience of sustained release dexamethasone intracanalicular insert (Dextenza™) following cataract surgery as part of a Phase III clinical trial program.MethodsThis cross-sectional, qualitative evaluation involved individual interviews lasting approximately 45 minutes. Patients from four US investigational study sites who had previously received an insert were enrolled. There were no predesignated end points; this was a qualitative survey seeking a deeper understanding of patient experience.ResultsTwenty-five patients were interviewed. Most patients (92%) reported the highest level of satisfaction grade with regard to overall product satisfaction. All patients described the insert as comfortable. Most patients (96%) described their overall experience with the insert as very convenient or extremely convenient. Twenty-two of 23 (96%) participants rated their experience with the insert as “very” or “extremely convenient”, compared to previous topical therapy, and 88% of patients stated that if they were to undergo cataract surgery again, they would request the insert. When asked if they would recommend the insert to family members or friends, 92% stated they would. The survey found that 84% of participants would be willing to pay more for the insert than for eye drop therapy.ConclusionThe dexamethasone insert was found by patients to be highly favorable with regard to overall satisfaction, convenience, and comfort. The insert was well received and largely preferred over topical therapy alternatives following surgery. More extensive evaluation of the patient experience is warranted, and future studies should help inform design of the next generation of sustained release drug delivery systems.

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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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Efficacy and Safety of Sustained Release Dexamethasone for the Treatment of Ocular Pain and Inflammation after Cataract Surgery: Results from Two Phase 3 Studies

Cited by 41 publications

References 27 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

Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza<sup>TM</sup>): results of a qualitative survey

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

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