Anterior Segment Intraocular Nonbiodegradable Drug-eluting System

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The Protecting Access to Medicare Act (PAMA) of 2014, Section 218(b), established a new program to increase the rate of appropriate advanced diagnostic imaging services provided to Medicare beneficiaries.

42 CFR §414.92 codifies the Appropriate Use Criteria Program policies.

Associated policies

L38299 Micro-Invasive Glaucoma Surgery (MIGS)

Background

Glaucoma is the second leading cause of blindness worldwide.¹ Current treatments target a reduction in intraocular pressure (IOP). The condition is characterized by “acquired atrophy of the optic nerve with loss of retinal ganglion cells and their axons”.¹ Elevated IOP is considered a significant risk factor for glaucoma development with additional risk factors including advancing age, black or Hispanic race, family history of glaucoma, and diabetes.¹

IOP elevation is associated with risk of development of open angle glaucoma (OAG), although some patients may develop glaucoma without elevated IOP.² The Ocular Hypertension Study reported the 5 years cumulative probability of developing primary open angle glaucoma (POAG) in subjects with a baseline untreated IOP of 24-32 mm Hg was 4.4% in the treatment group and 9.5% in the control group. Those with thinner corneas, higher pressures and older age were at the highest risk. They concluded using medicated eye drops in patients with elevated IOP between 24-32 mm Hg reduces the incidence of eye damage from glaucoma.^2,3 The Early Manifest Glaucoma Trial demonstrates IOP reduction in patients with OAG showed significantly delayed progression compared to the untreated control arm.⁴ There is evidence that reduction in IOP also reduces the risk of progression to glaucoma in those with ocular hypertension (OHT).⁵ The American Academy of Ophthalmology (AAO) Preferred Practice Guidelines states, “A reasonable initial treatment goal in a POAG patient is to reduce IOP by 20% to 30% below baseline and to adjust up or down as indicated by disease course and severity”.¹ Research to identify more accurate modalities to determine progression, and earlier and more accurate identification of patients at risk for glaucoma is needed.⁶

Adherence with topical treatment for OHT and POAG can be challenging, with reports of nonadherence averaging 50% in developed countries and reported ranges from 5-80%. Efforts to target and improve adherence are under consideration.⁷

Selective laser trabeculoplasty (SLT) is considered a primary treatment option for OAG.^1,8,9 In 2023, the results of the LiGHT trial demonstrated that SLT is effective in reducing IOP, and diminishes the need for incisional glaucoma surgery.¹⁰ This trial showed SLT to be a clinical and cost-effective primary treatment option for OAG up to 6 years with 692 patients in the initial 3 year trial and 524 completing a 6 year extension.¹⁰ A systematic review/meta-analysis (SR/MA) by Wong et al. evaluated the efficacy of SLT compared to argon laser trabeculoplasty and medication and reported SLT as equally efficacious as first-line medication with rare complications.¹¹ The 2024 AAO Technology Assessment on SLT states that SLT is an effective long-term option for the treatment of OAG and is equivalent to glaucoma medication based on Level 1 evidence. The assessment explains that SLT can be used as a primary intervention, a replacement for medication, or as an additional therapy with glaucoma medications.¹²

A single Food and Drug Administration (FDA) approved anterior segment intraocular nonbiodegradable drug-eluting system is considered reasonable and necessary for the management of OHT or POAG, per eye, when ALL of the following criteria have been met:

1. History of failed medical management, defined as:⁹
   1. Tried at least 2 ophthalmic topical drops (given as sequential monotherapies or together simultaneously) for the treatment of OAG or OHT AND
   2. The ophthalmic drops did not achieve the initial treatment goal of a reduction of 20% to 30% from the patient’s baseline IOP measurement OR
   3. Adverse side effects from different ophthalmic drops severe enough to warrant discontinuation OR
   4. The patient is unable to physically place eye drops due to disability such as severe tremors or loss of use of dominant hand and there is no caretaker who is able to perform the administration of the drops

AND

2. History of failed SLT, defined as the procedure did not result in clinically significant reduction of IOP ^9,10

Limitations:

1. Device implantation cannot be performed concomitantly with other eye surgeries or procedures except phacoemulsification cataract surgery.¹³ If performed with cataract surgery all criteria above must be met, and no other eye surgery can be performed at the same time.
2. Device implantation is not permitted when contraindications (as stated in the FDA label) are present.¹⁴
3. Device cannot be re-administered within 2 years of insertion.¹⁴
4. Preimplantation, the patient Central Corneal Endothelial Cell Density must be at or above the FDA label recommended Minimum Central Corneal Endothelial Cell Density.¹⁴

Additional considerations:

1. Patients should be informed that the Travoprost intracameral implant is magnetic resonance imaging (MRI) conditional and may impact future MRIs and require additional precautions to scan safely.¹⁵
2. If re-administration is performed because patient meets coverage criteria as noted above the previous implant must be removed after the new implant is inserted.¹⁴

A literature search was conducted using the following key words: Travoprost, implant, glaucoma, iDose, OHT, ocular implant, sustained release implant. The literature search was filtered to locate full-text articles, clinical trials, and systematic reviews/meta-analyses (SR/MA) in the English language, published within the last 5-10 years.

The certainty of evidence supporting the change in outcome due to the product being investigated and improved patients’ outcomes was evaluated. Case reports, case series and review papers were not included but they were reviewed to gain additional insights pertinent to this subject. Editorials and unpublished reports were not included in the analysis.

A travoprost intracameral implant is a biocompatible titanium reservoir preloaded in a single dose inserter that is designed to provide a slow sustained release of preservative-free travoprost and has received FDA approval for re-administration under specified conditions.¹⁴ The previous implant must be removed after the insertion of the new implant.¹⁴ According to a randomized controlled trial (RCTs) from Berdahl and colleagues published in 2024, investigators reported a 3-year reduction in baseline IOP for patients using the slow eluting (SE) iDose®TR implant with placebo eye drops.¹⁶ Reductions in the implant group ranged from 7.3-8 mmHg as compared to 7.3-7.9 mmHg seen in the control group (topical timolol drops with sham procedure). The investigators also reported that 63-69% percent of patients in the implant group achieved IOP control at 3 years as compared to 45% of the timolol control group.^16-20 The evidence of these RCTs demonstrates moderate certainty that the travoprost implant is effective at reducing IOP as compared to placebo (see Tables 1-3).

Table 1: Randomized Controlled Trials

BID = two times per day, FE = fast-eluting implant, IOP = intraocular pressure, OAG = open angle glaucoma, OHT = ocular hypertension, SE = slow-eluting

Table 2: Quality of Evidence for RCT

ANOVA = Analysis of Variance, COI = Conflict of Interest, FE = fast-eluting implant, IOP = intraocular pressure, LS = Least Squares, OAG = open angle glaucoma, OHT = ocular hypertension, PGA = topical prostaglandin analog, SD = Standard Deviation, SE = slow-eluting, ITT = Intention to Treat

Table 3: Certainty of Evidence Assessment for RCTs

Question: Travoprost Intraocular Implant compared to Standard of Care (SOC)/sham in Patients with POAG or OHT

Mean Reduction in IOP at 12 Months

Mean Reduction in IOP at 36 Months

Serious TEAEs

CI: confidence interval; MD: mean difference

Explanations

1. Various medications before enrollment, varied washout periods, comparator not the same class of medication as the implant
2. Small sample size with wide CI.
3. The total number of events is extremely low, resulting in unstable estimates and could change significantly with just one or two more events.

Observational studies

A prospective, open-label, single-arm trial (NCT06061718) at one site in Armenia followed 60 patients for 12 months with age-related cataracts and OAG or OHT with baseline unmedicated IOP between 24-36 mmHg.¹³ Patients underwent uncomplicated phacoemulsification cataract surgery and had a travoprost intracameral implant placed at the time of surgery. The baseline unmedicated mean diurnal IOP was 25.2 mmHg. At month 3, IOP change from baseline was −10.6 mmHg (95% confidence interval: −11.2, −9.9; p < 0.0001) representing a 20% or greater mean diurnal IOP reduction from baseline for 96.7% of patients. The mean diurnal IOP of 18 mmHg or less was achieved in 91% of patients. The authors reported no serious adverse events, only minor events in 8.3% of patients, most commonly dry eyes. This study is limited by a patient population representing a single site in Armenia (thus lacking generalizability), short term follow-up, small sample size, lack of randomization or control, and lack of comparison to IOP results after cataract surgery alone, altogether making it unclear if the results are attributed to the implant or cataract surgery or a combination of both procedures.

A 24 month long, prospective, single-centered, open-label study (NCT06582732) enrolled 210 subjects, administering a travoprost intracameral implant for OAG or OHT and then evaluating the levels of travoprost free acid (TFA) in the aqueous humor and the implant’s medication elution rate.²¹ The investigators reported that concentrations of TFA in aqueous humor remained above minimum thresholds throughout the 24 months and indicated that there is potential benefit beyond 24 months for efficacious drug delivery. Limitations include study performance at a single site in Armenia, thus lacking generalizability.

A retrospective case series evaluated 65 eyes with OAG or OHT implanted with the travoprost intracameral implant (iDose® TR).²² The investigator reported a reduction in IOP from 19.6±3.8 mmHg at baseline to 13.1±2.5 mmHg 1 month post-procedure, representing a 33.2% reduction (p=0.001). The percentage of eyes with IOP ≤15 mmHg increased from 11.1% to 83.3% at 3 months (p=0.001). The report was limited by retrospective design and small sample size.

Contractor Advisory Committee (CAC) Meeting

A multi-MAC CAC meeting was hosted by CGS Administrators, Noridian, National Government Services, Palmetto GBA and Wisconsin Physician Services on 11/12/2025 and can be accessed from each MACs’ websites. Subject matter experts (SMEs) stated the mainstay for treatment of glaucoma is lowering IOP with individualized targets. Examination findings including visual fields represent an important modality to measure glaucoma progression. The SMEs felt there is sufficient evidence to be confident that the bimatoprost sustained release and travoprost intracameral implants are effective for reduction in IOP for patients with OAG. They agreed that the standard of care (SOC) medical management for patients OAG starts with topical eye drops and SLT before other interventions are pursued. They overall felt that implants are useful in management of glaucoma but lack standardized criteria for determining who are optimal patients for these devices. The SMEs responses to voting questions regarding off-label use of travoprost intracameral implants included:

• To support the use of this implant beyond 24 months, SMEs voted the certainty of evidence as low (2/7), moderate (3/7), and high (2/7). A paper that demonstrated safety up to 3 years was cited.¹⁶
• For certainty of evidence to support the use of the device at the time of cataract surgery, SMEs voted very low (1/7), low (1/7), moderate (4/7) and high (1/7). A poster presenting the 12 month data from Singh’s study was cited as demonstrating safety.¹³
• For certainty of evidence regarding the use of the device coincidently with MIGs surgery or titanium stents, or following placement of a different intracameral implant, SMEs voted certainty of evidence as none (2/7), very low (3/7), and low (1/7). They explain the only evidence is in case reports, but studies are ongoing.
• For use in patients with permanently implanted titanium stents, SMEs rated certainty of evidence as no evidence (1/7), very low (4/7), low (1/7) and high (1/7). The only evidence is case reports, with one SME suggesting the effect may be complementary.
• For use in conjunction with another implant in a different segment of the eye, such as implant into the lacrimal canaliculus, SMEs rated certainty of evidence as no evidence (3/7), very low (3/7) and high (1/7). No supporting references were identified, but one SME stated they would not be concerned due to devices inhabiting different spaces.
• For certainty of evidence to support repeating the device after 24 months, SMEs rated the certainty of evidence as no evidence (3/7), very low (2/7), low (1/7) and high (1/7). Regarding the question whether repeat implantation provides equivalent efficacy in IOP lowering compared with the first implantation or if there is evidence of diminishing benefit, one SME shared an ongoing study with promising results in 33 subjects.
• Some SMEs would remove the device if re-implantation (4/7) was performed while others would leave the device in place (3/7). For the question regarding possible cumulative risks of multiple implants (e.g., endothelial health, inflammatory events, device retention) and if this should be a limitation of use until further investigations and longer-term outcome data is obtained, SMEs responded with mixed opinions. Some were conservative in awaiting data to understand the risk of repeat usage, while one SME stated concern with access to Schlemm canal for MIGs implants (the travoprost intracameral implant would already be present in this location but would not impact trabecular stents, goniotomy, canaloplasty or filtering surgeries), and another SME felt the risk of vision loss from glaucoma outweighs the risk from the unknowns of the implant. Several SMEs stated that the small size of iDose would not be expected to have cumulative adverse effects. These questions were asked prior to the FDA label change for iDose® TR.¹⁴.

Societal Input

The AAO Preferred Practice guidelines utilize the Scottish Intercollegiate Guideline Network (SIGN) for rating of studies and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for making recommendations. Glaucoma Summary Benchmarks⁹ state target range of IOP may be individualized and is typically aiming for 25% reduction of IOP from pretreatment IOP levels using medication and/or laser or incisional surgery. The guidelines state SLT may be used as initial or adjuvant therapy in management of POAG. The guidelines do not mention intraocular implants for delivery of medication.

Using GRADE methodology, the analysis of evidence determines there is moderate certainty evidence that the travoprost intracameral implant is effective at reduction of IOP as compared to placebo for OHT and OAG for up to 36 months based on 3 RCTs. While the initial studies report safe use of the implant up to 36 months, there is a lack of long-term data or understanding how the travoprost intracameral implant affects patients or impacts future procedures on their eyes. We do not consider the travoprost intracameral implant a first line therapy. There is high quality evidence and societal support for glaucoma medication and SLT for first line management. While the travoprost intracameral implant does deliver medication it requires a corneal incision which is a surgical procedure for insertion and removal and an implant which is not free from risk. Additionally, there are a lack of studies comparing iDose to the standard of care that utilizes both topical medications and SLT.” Therefore, the LCD limits coverage to patients who fail primary management with topical medication and SLT. This approach ensures access to novel new technologies but does not replace first line treatment in the absence of evidence or societal support that this device is equivalent. The limited coverage does not permit off-label use outside of the areas in which it has been investigated.

There is low certainty evidence to support the use of the travoprost intracameral implant at the time of cataract surgery for 12 months, although there was no evidence of serious harm in the one study evaluating this combined procedure.¹³ Insertion of travoprost intracameral implant coincident with cataract surgery was supported by the majority of SMEs. Moreover, since it is clinically optimal to perform procedures at the same time and reduce the risks associated with multiple surgeries/procedures, if a patient meets all criteria for the travoprost intracameral implant, it may be inserted at the time of cataract surgery. However, no other stent or MIGs procedure can be performed coincident with the travoprost intracameral implant insertion since these combination procedures are not currently supported by evidence.

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1. AAO. Primary Open-Angle Glaucoma Preferred Practice Pattern®. https://www.aaojournal.org/action/showPdf?pii=S0161-6420%2820%2931024-1. Published 2021. Updated 2021. Accessed 12/29/25.
2. Deborah S Jacobs M. Open-angle glaucoma: Epidemiology, clinical presentation, and diagnosis. https://www.uptodate.com/. Published 2025. Accessed 12/17/25.
3. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: A Randomized Trial Determines That Topical Ocular Hypotensive Medication Delays or Prevents the Onset of Primary Open-Angle Glaucoma. Archives of Ophthalmology. 2002;120(6):701-713.
4. Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120(10):1268-1279.
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6. Naik V OS, Fernandez E, Mwanza J-C, Fleischman D Changes in individuals’ glaucoma progression velocity after IOP-lowering therapy: A systematic review. PLoS One 2025;5: e0324806.
7. Bott D, Subramanian A, Edgar D, Lawrenson JG, Campbell P. Barriers and enablers to medication adherence in glaucoma: A systematic review of modifiable factors using the Theoretical Domains Framework. Ophthalmic and Physiological Optics. 2024;44(1):96-114.
8. Deborah S Jacobs M. Open-angle glaucoma: Treatment. https://www.uptodate.com. Published 2025. Updated 8/12/25. Accessed 9/19/25.
9. AAO. Summary Benchmarks For Preferred Practice Pattern® Guidelines. www.aao.org. Published 2024. Updated 12/2024. Accessed 12/29/2025.
10. Gazzard G, Konstantakopoulou E, Garway-Heath D, et al. Laser in glaucoma and ocular hypertension (LiGHT) trial: six-year results of primary selective laser trabeculoplasty versus eye drops for the treatment of glaucoma and ocular hypertension. Ophthalmology. 2023;130(2):139-151.
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12. Takusagawa HL, Hoguet A, Sit AJ, et al. Selective laser trabeculoplasty for the treatment of glaucoma: a report by the American Academy of Ophthalmology. Ophthalmology. 2024;131(1):37-47.
13. Singh IP, Voskanyan LA, Barber KM, et al. Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery. Therapeutic Advances in Ophthalmology. 2025;17:25158414241310275.
14. FDA. NDA 218010. IDose Web site. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218010s004lbl.pdf. Published 2001. Updated 01/26. Accessed 2/3/26.
15. Glaukos. iDose® TR Prescribing Information. Glaukos. https://www.glaukos.com/prescribing-information/idosetr. Accessed 2/3/2026.
16. Berdahl JP, Sarkisian SR, Jr., Ang RE, et al. Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension. Drugs. 2024;84(1):83-97.
17. Sarkisian SR, Ang RE, Lee AM, et al. Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmology. 2024;131(9):1021-1032.
18. Sarkisian SR, Ang RE, Lee AM, et al. Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial. Ophthalmol Ther. 2024;13(4):995-1014.
19. Singh IP, Berdahl JP, Sarkisian Jr SR, et al. Long-term safety and efficacy evaluation of travoprost intracameral implant based on pooled analyses from two phase III trials. Drugs. 2024;84(10):1299-1311.
20. Bacharach J, Doan LV, Stephens KG, et al. Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmology and Therapy. 2024;13(9):2357-2367.
21. Szekely G, Voskanyan LA, Stephens KG, et al. Aqueous Humor Concentrations of Travoprost Free Acid and Residual Drug in Explanted Implants from Patients Administered a Travoprost Intracameral Implant. Ophthalmology and Therapy. 2025:1-15.
22. Teymoorian S, Kaur J. Travoprost Intracameral Implant in Eyes with Glaucoma or Ocular Hypertension: Early Short-Term Real-World Outcomes. Clinical Ophthalmology. 2025:157-166.
23. Cheng CM, Rehmani C, Chin J. Prostaglandin Intracameral Implants for Ocular Hypertension and Open-Angle Glaucoma. Journal of Pharmacy Technology. 2025;41(3):144-150.
24. Elhusseiny AM, Aref AA. Sustained Release Therapies with the Prostaglandin Analogues Intracameral Implants. Ophthalmology and Therapy. 2024;13(7):1833-1839.
25. Ichhpujani P, and Thakur, S. . iDose TR Sustained-release Travoprost Implant for the Treatment of Glaucoma. US Ophthalmic Review. 2023;17(1):4-6.
26. Chan L, Moster MR, Bicket AK, et al. New Devices in Glaucoma. Ophthalmol Ther. 2023;12(5):2381-2395.

Reviewed but not cited: Cheng²³, Elhusseiny²⁴, Ichpujani²⁵, Chan²⁶

• Provider Education/Guidance