Medical Policies - Surgery


Drug-Eluding Intracanalicular Punctal Plugs and Ocular Inserts

Number:SUR713.035

Effective Date:07-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Drug-eluting intracanalicular punctal plugs and drug-eluting ocular inserts are considered experimental, investigational and/or unproven.

Description:

Intracanalicular Punctal Plugs

Intracanalicular plugs, also known as punctal plugs, lacrimal plugs, or occluders, are small, absorbable polyethylene glycol hydrogel plugs that are used to deliver a sustained, therapeutic level of medication to targeted ocular tissue. The intracanalicular plug is designed to be absorbed, and exit the nasolacrimal system without need for removal by the physician. The plugs contain a visualization agent for retention monitoring throughout the treatment period. (1, 2)

Physicians typically use a topical or local anesthetic prior to inserting a punctal plug. Each eyelid has one punctum, located at its inner margin near the nose. Punctal plugs can be inserted in the puncta of the lower lids, the upper lids or both. An instrument may be used to dilate the tear duct opening for easier insertion. Some punctal plugs are inserted just into the puncta so they still can be seen and mechanically removed if necessary. Other punctal plugs are inserted deeper into the canaliculus. This type of plugs, technically called intracanalicular plugs, does not protrude from the punctum. They are not visible or felt, and conform to the shape of the cavity. If removal is indicated, intracanalicular plugs are extracted by flushing them out. Once inserted, punctal plugs can last from several days to several months. Punctal plugs have been used for individuals with a diagnosis of dry eye syndrome (DES) and keratoconjunctivitis sicca (KCS) for many years and are actively being investigated as a way to deliver medications (drug eluting) for the treatment of post-operative inflammation and pain, allergic and bacterial conjunctivitis, and for the treatment of glaucoma and ocular hypertension.

The potential risks associated with the use of intracanalicular plugs include transient discomfort after insertion, infection, canaliculitis, and migration further into the drainage canal or stenosis (narrowing) of the intracanalicular canal. When the plug unexpectedly migrates outside the target area and deeper into the eye's drainage channels, this can create blockages leading to dacryocystitis which can cause inflammation of the nasolacrimal sac, infection with swelling, and pain and discomfort. Soft types of punctum plugs generally can be removed by flushing them out (irrigation). However, surgery might be needed when a punctum plug migrates into the eye drainage canal. (1)

Ocular Inserts

The manufacturer believes that an ocular insert represents a significant advancement in the therapy of eye disease. Ocular inserts are sterile, thin, multilayered, drug-impregnated, solid or semisolid consistency devices that are placed into the cul-de-sac or conjunctival sac. Inserts have a size and shape designed for ophthalmic application. They have a polymeric support that may or may not contain a drug initially. However, a drug can be incorporated later as dispersion or a solution in the polymeric support. Ocular inserts are classified according to their solubility as insoluble, soluble, or bio-erodible. Drug release from an insert depends on the diffusion, osmosis, and bio-erosion characteristics of the drug utilized. (2)

The manufacturer cites the following potential advantages of ocular inserts over traditional ophthalmic preparations (3):

Increased ocular residence, hence, prolonged drug activity and higher bioavailability;

Release of drugs at a slow, constant rate;

Accurate dosing (insert contains a precise dose, which is fully retained at the administration site);

Reduction of systemic absorption;

Better patient compliance, due to reduced frequency of administration and less incidence of visual and systemic side-effects;

Possibility of targeting internal ocular tissues through non-corneal (conjunctival scleral) routes;

Increased shelf life with respect to aqueous solutions;

Exclusion of preservatives, thus reducing the risk of sensitivity reactions;

Incorporation of various novel chemical / technological approaches, such as pro-drugs, mucoadhesives, permeation enhancers, micro particulates, salts acting as a buffer.

Potential risks of ocular inserts can include (3):

Sensation of a foreign body in the eye, a physical and psychological barrier to patient compliance;

Insert migration, making insert removal more difficult;

Unintentional loss during sleep or from rubbing the eyes;

Interference with vision.

Regulatory Status

Intracanalicular Punctal Plugs

The following drug-eluting intracanalicular punctal plugs are not actively approved by the U.S. Food and Drug Administration (FDA), although some are in clinical trials. (4-6)

Dexamethasone punctum plug (OTX-DP; Ocular Therapeutix, Bedford, MA.);

Travoprost punctum plug (OTX-TP2; Ocular Therapeutix, Bedford, MA.);

Punctal plug for the delivery of latanoprost (Mati Therapeutics, Austin, TX.);

ENV515 or travoprost XR (Envisia Therapeutics, Durham, NC; acquired by Aerie Pharmaceuticals, Inc. in 2017).

Ocular Inserts

Forsight Vision Incorporated (7) developed the Helios™ bimatoprost ocular insert which is a bimatoprost-laden polymer-matrix insert embedded in a compliant ring. The ring is positioned under the upper and lower eyelids and rests on the conjunctiva. It is visible only at the caruncle once it is in place. The ring is designed to be replaced by a physician every 6 months. This device is not approved by the U.S. FDA and is restricted to investigational use only.

Rationale:

This policy was originally created in July 2014 and has been updated regularly with searches of the Medline database. Most recently, the literature was searched through May 31, 2018. Following is a summary of the key literature to date.

Punctal Plugs

In 2012, Chee et al. published two phase 1 trials that evaluated moxifloxacin punctum plugs for sustained drug delivery. (8) The purpose was to assess the safety and feasibility of a moxifloxacin-loaded sustained drug delivery punctal plug (MP) following cataract surgery in 2 groups of cataract patients. Two prospective, single-arm, phase I studies were conducted with 20 cataract patients (10 per study). After cataract surgery, the MP was inserted into the punctum, and follow-up assessments were conducted at 1 hour, 24 hours, and on day 3, 7, 10, 20, and 30. Study endpoints included MP retention, ease of placement, and moxifloxacin concentrations in the tear fluid. Moxifloxacin concentrations were targeted to be ≥250 ng/mL through 7 days, with detectable levels through day 10. After the course of therapy, the plug would resorb and be absent from the punctum by day 30. Slit lamp evaluations were performed, and intraocular pressure measurements were performed on day 1, 3, 7, 10, 20, and 30. Patients were queried for the presence or absence of several ocular sensations in the operative eye. Due to the variability in tear film antibiotic concentrations observed in the first study, a second study was conducted with more stringent concomitant drop administration and tear sample collection criteria. The results revealed that the MP retention in the punctum was 95% (19/20) through day 10, and all plugs were absent at day 30. Average moxifloxacin concentrations in the tear film ranged from 155 to 785 ng/mL for Study 1 and 2,465 to 3,236 ng/mL for Study 2 through day 7. These values were above the target of 250 ng/mL for all time points except for day 1 of Study 1. For both studies, moxifloxacin concentrations in the tear film were above detectable levels at day 10. The plugs were well tolerated, and there were no adverse events as defined by the protocol, and no ocular complaints or findings other than normal post-cataract symptoms. The study concluded that the MP delivered and maintained moxifloxacin tear fluid concentrations at therapeutic levels above the MIC90 values for common susceptible conjunctivitis pathogens for 7 days (Study 2). The MP also exhibited a favorable safety and tolerability profile and, hence, may be a viable alternative to topical antibiotic drops for the treatment of bacterial conjunctivitis. Although moxifloxacin has shown high penetration in the ocular tissues, aqueous taps would be necessary to determine whether the drug’s levels are sufficient for prophylactic use following surgery. Even then, proof of efficacy could not be shown without examining thousands of patients to determine the prevention of endophthalmitis. Despite these issues, additional prospective studies are warranted to examine the full use and effect of the moxifloxacin punctal plug.

On October 1, 2013, Phase 2 sustained release dexamethasone (OTX-DP) study for the treatment of post-operative inflammation and pain was initiated. (4) A randomized, placebo-controlled clinical trial was conducted under an investigational new drug (IND) submission to the U.S. Food and Drug Administration (FDA). Sixty patients undergoing cataract surgery were administered OTX-DP or a proprietary placebo intracanalicular plug at the conclusion of surgery. Primary end points included reduction of inflammation as determined by absence of anterior chamber cells and absence of pain. Results showed that 34.5% percent of patients administered OTX-DP had an anterior chamber cell count of zero on Day 14, opposed to 3.4% of patients in the control group (p=0.0027). The OTX-DP group was statistically superior to the control group for absence of pain at all time-points evaluated through day 30. One hundred percent of OTX-DP plugs were retained through Day 14, and 96.6% of plugs were retained through Day 28. Results are comparable to commercially available ophthalmic corticosteroids. There were no increases in intraocular pressure related to OTX-DP. They thought reducing the number of post-surgical drops a patient must take while increasing dosing compliance could positively impact healing time and post-operative results. Ocular Therapeutix has consulted with the FDA to finalize plans to move the drug product into Phase 3 trials. This is the first randomized, controlled, multi-center clinical study of a sustained release anti-inflammatory agent delivered via intracanalicular plugs, to demonstrate compelling efficacy, ever to be conducted by any company in the U.S. The plugs were highly retained and with less than a 10% drug load compared to drops, and performed excellently in safety as well as efficacy, stated Ocular Therapeutix, Inc.

In 2007, Mazow et al. researched complications and success of treatment of migrated or lodged intracanalicular and punctal plugs. (9) A retrospective chart review of all cases having either a dacryocystorhinostomy or surgical removal of an intracanalicular or punctal plug from 1992 to 2006, in a single physician referral oculoplastics practice, was performed to identify cases in which a retained lacrimal plug required surgical intervention. Patients presented with symptoms of tearing, infection, or granuloma formation. The charts of 998 surgical cases were reviewed, from which 66 eyes (6.6%) were determined to have had lodged lacrimal plugs that required surgical removal. Patients were followed after surgery until reconstructive silicone tubing was removed (range, 6 weeks to 6 months), and each patient was questioned regarding symptoms. A comparison group of 336 eyes that had collared punctal plugs placed served as the control group. All cases were noted to have complications from intracanalicular plugs. No complications were noted from other forms of lacrimal plugs. All eyes in this series required a canaliculotomy or a dacryocystorhinostomy after office irrigation failed to dislodge the plug. Five eyes presented with canaliculitis, 28 eyes presented with epiphora, and 29 eyes presented with dacryocystitis. Four of 66 eyes (6%) in this cohort presented with a pyogenic granuloma. Five eyes (8%) presented with canaliculitis. Forty-nine of 66 eyes (74%) were asymptomatic following treatment, with no observable infection or epiphora. Seven of 66 eyes (11%) had some improvement in symptoms and another 10 of 66 eyes (15%) had no change in symptoms after treatment. No complications requiring surgical intervention were encountered in the control group of collared punctal plugs. The study determined that intracanalicular-type plugs may lodge in the lacrimal outflow system. This may result in epiphora, canaliculitis, or dacryocystitis that may require major reconstructive surgery. Despite surgical intervention, these symptoms do not always resolve (26% of eyes in this study had persistent epiphora). Intracanalicular plugs were observed to be associated with a higher rate of granulation tissue formation in the lacrimal outflow tract when compared with other forms of punctal plugs. As a result of the increased number of complications seen with intracanalicular plugs, caution is advised with respect to use of these devices. The relative infrequency of complications seen with collared punctal plugs suggests a safer alternative. Data from this study lead the authors to advocate the consideration of other forms of lacrimal occlusion due to the high number of complications noted with intracanalicular plugs, and the availability of other reversible forms of punctal occlusion.

In January 2015, a phase 3 clinical trial (NCT02089113) was completed that compared OTX-DP (resorbable hydrogel dexamethasone punctum plug) as a sustained release drug depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain. (10) Inclusion criteria comprised of individuals 18 years of age or older who have a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens and has a potential post-operative pinhole corrected Snellen Visual Acuity of at least 20/200 or better in both eyes. Individuals were excluded if any intraocular inflammation in the study eye was present during the screening slit lamp examination, scored greater than "0" on the ocular pain assessment in the study eye at screening or had any intraocular inflammation in the study eye present during the screening slit lamp examination. The primary outcome measure was absence of inflammatory cells in the anterior chamber at day 2, 4, 8, 30; the secondary outcome measure was the presence of cells in the anterior chamber at day 2, 4, 14, 30. One hundred sixty-one participants were in the OTX-DP arm and 80 participants were in the placebo arm (n=240). One individual in the OTX-DP arm did not complete the study. On day 14, the primary efficacy measures were met as evidenced by the absence of cells in anterior chamber of the study eye, achieving a statistically significant improvement in the reduction of inflammatory cells and pain in the cataract patients. No adverse events were identified in the OTX-DX arm and 1 adverse event was noted in the placebo arm. No additional information was identified in the published literature.

In January 2015, Ocular Therapeautix Incorporated completed a single center, randomized, double-masked, controlled phase 2/3 study (NCT02062905) to evaluate the efficacy and safety of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid of 60 patients for the treatment of chronic allergic conjunctivitis. (11) Enrollment was by invitation only. Inclusion criteria comprised of individuals 18 years of age or older, have a positive history of ocular allergies and a positive skin test reaction to a perennial allergen, and have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Individuals were excluded if the participant had known contraindications or sensitivities to the use of any of the product medication or components or had ocular surgical intervention within 3 months prior to visit 1 or during the study and/or a history of refractive surgery within the past 3 months. Sixty-eight participants (n=68) were enrolled. The primary outcome measure was evaluation of ocular itching at 14 days’ post insertion using the Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0-4 with 0.5 unit increments allowed; "0" = no itching). The secondary outcome measure was evaluation of conjunctival redness 14 days post insertion using the Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness). Twenty-eight participants (n=28) were in the OTX-DP arm and 31 participants were in the placebo arm. Ocular itching (primary outcome measure) in the treatment arm was 1.80 at 3 minutes, 1.72 at 5 minutes and 1.65 at 7 minutes. Ocular itching in the placebo arm was 2.58 at 3 minutes, 2.70 at 5 minutes and 2.52 at 7 minutes. Conjunctival redness (secondary outcome measure) was evaluated by units on a scale 0–4. The OTX-DP treatment arm (n=28) was 1.60 at 7 minutes (14 days post-insertion), 1.53 at 15 minutes and 1.54 at 20 minutes. The placebo arm (n=31) were 2.11 at 7 minutes, 2.23 at 15 minutes and 2.21 at 20 minutes. One adverse event of depression was noted in the OTX-DP treatment arm (3.23%). Other adverse events included 1 participant with eye drainage in the treatment arm (3.23%) and 2 in the placebo arm (6.06%).

In 2016, Walters et al. (12) evaluated the safety and efficacy of OTXDP, a sustained-release dexamethasone punctum plug when placed in the canaliculus of the eyelid for the treatment of post-surgical pain and inflammation in patients who had undergone cataract surgery. Two prospective, phase 3, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled studies (referred to as Study 1 and Study 2) were conducted across 32 private practice sites in the U.S. Patients were randomized (2:1) on Day 1 to receive a sustained release dexamethasone depot, (0.4 mg; Study 1, n=164; Study 2, n=161) or placebo vehicle depot (Study 1, n=83; Study 2, n=80) in the inferior canaliculus. The primary endpoint for ocular pain was met in both studies; statistically higher proportions of patients in OTX-DP groups, compared with placebo groups, had no ocular pain at day 8. However, the inflammation endpoint was met only in study 1. The authors suggest that this endpoint failed to reach statistical significance in study 2 because of an unusually high percentage of placebo group patients without anterior chamber cells at day 14. Significantly fewer OTX-DP group than placebo group patients required rescue medications on study days 8 and 14; this endpoint did not statistically differ on study days 1, 2, and 4. No treatment-related adverse events were reported. OXTDP is currently undergoing U.S. FDA review.

In 2017, Torkildsen et al. (13) conducted a randomized, double-masked, vehicle-controlled, phase 2 study to evaluate the efficacy and safety of a sustained-release dexamethasone intracanalicular insert (Dextenza™) for treating allergic conjunctivitis. The subjects included in the study had to have a positive conjunctival allergen challenge (CAC) reaction to allergen at Visit 1, and for 2 of 3-time points on subsequent visits. Subjects who met entry criteria were randomized to receive Dextenza or PV (vehicle insert). Challenges occurred over 42 days, with efficacy assessed at 14 (primary endpoint visit), 28, and 40 days postinsertion. Outcome measures included the evaluation of ocular itching, redness, tearing, chemosis, eyelid swelling, rhinorrhea, and congestion. Twenty-eight subjects completed the study in the Dextenza group and 31 in the vehicle group. At 14 days postinsertion, Dextenza was statistically superior to PV. Clinical significance, defined as a 1-U decrease from PV, was not met for primary efficacy. Secondary endpoints, including number of subjects reporting itching and conjunctival redness, indicated superior performance of Dextenza compared with vehicle. Eleven Dextenza-treated (35.5%) and 10 vehicle-treated (30.3%) subjects each experienced a single adverse event. The authors concluded that this Phase 2 study demonstrated preliminary efficacy and safety data of Dextenza for treatment of allergic conjunctivitis. Additional well-designed randomized clinical trials with extended follow-up are necessary to evaluate the long-term efficacy and late complications of these intracanalicular inserts.

Professional Guidelines and Position Statements

American Academy of Ophthalmology (AAO)

The AAO 2015 Conjunctivitis Summary Benchmark (14) and the 2016 Preferred Practice Pattern Guideline for Primary Open-Angle Glaucoma (15) do not indicate drug-eluting intracanalicular punctal plugs as a treatment modality.

Ongoing and Unpublished Clinical Trials

A clinical trial with the sponsorship of Ocular Therapeutix, Inc. included the non-significant risk feasibility study (NCT01800175) which is an interventional study to evaluate the retention and replacement of the OTX Punctum Plug when placed in the canaliculus of the eyelid. (16) Subjects will be followed for up to 1 year. Primary Outcome Measures include Punctum Plug retention for 90 days post insertion and retention of the first OTX Punctum Plug through Day 90, retention of the second OTX Punctum Plug through Day 180, retention of the third OTX Punctum Plug through Day 270, and retention of the fourth OTX Punctum Plug through Day 360. The estimated completion date is December 2016. As of May 31, 2018, no results have been posted.

Ocular Inserts

In 2016, Brandt et al. (17) completed a parallel-arm, multicenter, double-masked, randomized, controlled trial comprised of 130 adult open-angle glaucoma (OAG) orocularhypertension (OHT) patients that were treated for 6 months. Eligible patients were randomized 1:1 to receive a bimatoprost insert plus artificial tears twice daily or a placebo insert plus timolol (0.5% solution) twice daily for 6 months after a screening washout period. Diurnal IOP measurements (at 0, 2, and 8 hours) were obtained at baseline; weeks 2, 6, and 12; and months 4, 5, and 6. Key eligibility included washout intraocular pressure (IOP) of 23 mmHg or more at time 0, IOP of 20 mmHg or more at 2 and 8 hours, and IOP of 34 mmHg or less at all-time points; no prior incisional surgery for OAG or OHT; and no known nonresponders to prostaglandins. The primary efficacy end point examined the difference in mean change from baseline in diurnal IOPs (point estimate, 95% confidence interval) across 9 coprimary end points at weeks 2, 6, and 12 comparing the bimatoprost arm with the timolol arm using a noninferiority margin of 1.5 mmHg. Secondary end points were diurnal IOP measurements at months 4, 5, and 6 and adverse events (AEs). A mean reduction from baseline IOP of -3.2 to -6.4 mmHg was observed for the bimatoprost group compared with -4.2 to -6.4 mmHg for the timolol group over 6 months. The study met the noninferiority definition at 2 of 9 time points but was underpowered for the observed treatment effect. Adverse events (AEs) were consistent with bimatoprost or timolol exposure; no unexpected ocular AEs were observed. Primary retention rate of the insert was 88.5% of patients at 6 months. The study concluded clinically relevant reduction in mean IOP was observed over 6 months with a bimatoprost ocular insert and seems to be safe and well tolerated. The topically applied bimatoprost insert may provide an alternative to daily eye drops to improve adherence, consistency of delivery, and reduction of elevated IOP.

To date, the Helios™ bimatoprost ocular insert is not U.S. FDA approved and is restricted to investigational use only. (7)

Professional Guidelines and Position Statements

The AAO 2015 Conjunctivitis Summary Benchmark (14) and the 2016 Preferred Practice Pattern Guideline for Primary Open-Angle Glaucoma (15) do not indicate ocular inserts as a treatment modality.

Ongoing and Unpublished Clinical Trials

A search of clinicaltrials.gov identified there are multiple studies in progress to evaluate the use of ocular inserts for primary open-angle glaucoma and ocular hypertension.

Summary of Evidence

Drug eluting punctal plugs and ocular inserts are an emerging technology developed to potentially improve compliance in individuals with post-operative inflammation and pain, allergic and bacterial conjunctivitis, glaucoma and ocular hypertension. To date, drug-eluting punctal plugs and ocular inserts are not approved by the U.S. Food and Drug Administration (FDA). There is insufficient evidence that demonstrate that drug-eluting punctal plugs and ocular inserts improves the long-term net health outcome in patients. FDA approval and long-term, high quality studies are needed to determine the overall safety, efficacy and long-term improvement on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0356T, 0444T, 0445T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Haddrill M. Punctal Plugs For Dry Eyes. 2017. Available at <http://www.allaboutvision.com> (accessed May 20, 2018).

2. Kumari A, Sharma PK, Garg VK, et al. Ocular Inserts-Advancement in Therapy of Eye Disease. J Adv Pharm Technol Res. July 2010; 1(3):291-296. PMID 22247860

3. Deivasigamani K, Mithun B, Vijay Prakesh P, et al. The Concept of Ocular Inserts As Drug Delivery Systems: An Overview. Asian Journal of Pharmaceutics. October-December 2008; 194. Available at <http://www.asiapharmaceutics.info> (accessed May 25, 2018).

4. Ocular Therapeutix Inc. - Drug Eluting Punctum Plugs. Bedford, MA. 2018. Available at <http://ocutx.com> (accessed May 25, 2018).

5. Mati Therapeutics Inc. - Punctal Plug Delivery System. Austin, Tx. 2018. Available at <http://www.matitherapeutics.com> (accessed May 25, 2018).

6. Aerie Pharmaceuticals Announces Drug Delivery Asset Acquisition to Further Advance Its Retinal Disease Program. October 2017. Available at <https://seekingalpha.com> (accessed May 25, 2018).

7. Forsight VISION5s Clinical Data Demonstrating 6-month IOP Lowering From A Single Dose Presented At World Glaucoma Congress: Company Completes Enrollment of Phase 2 Dose-Ranging Study. June 11, 2015. Available at <http://www.prnewswire.com> (accessed May 25, 2018).

8. Chee, Soon-Phalk. Moxifloxacin punctum plug for sustained drug delivery. Journal of Ocular Pharmacology and Therapeutics. 2012 August; 28(4):340-349. PMID 22191856

9. Mazow ML, McCall T, Prager TC, et al. Lodged Intracanicular Plugs as A Cause of Lacrimal Obstruction, Opthal Plast Reconstru Surg. 2007 March-April; 23(2):138-42. PMID 17413630

10. Clinical Trial- Second Phase Three Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery (NCT02089113). Ocular Therapeutix. Available at <http://www.clinicaltrials.gov> (accessed May 31, 2018).

11. Clinical Trial- Phase 2/3 Study Evaluating Efficacy and Safety of OTX-DP for Treatment of Chronic Allergic Conjunctivitis (NCT02062905). Ocular Therapeutix. Available at <http://www.clinicaltrials.gov> (accessed May 31, 2018).

12. Walters T, Bafna S, Vold S, et al. Efficacy and Safety of Sustained Release Dexamethasone for the Treatment of Ocular Pain and Inflammation after Cataract Surgery: Results from Two Phase 3 Studies. J Clin Exp Ophthalmol. 2016; 7:1000572

13. Torkildsen G, Abelson MB, Gomes PJ, et al. Vehicle-controlled, phase 2 clinical trial of a sustained-release dexamethasone intracanalicular insert in a chronic allergen challenge model. J Ocul Pharmacol Ther. 2017 Mar; 33(2):79-90.

14. American Academy of Ophthalmology. Conjunctivitis Summary Benchmarks for Preferred Practice Pattern® Guideline. San Francisco, CA: American Academy of Ophthalmology (2015). Available at <http://www.aao.org> (accessed May 31, 2018).

15. American Academy of Ophthalmology. Preferred Practice Pattern® Guidelines for Primary Open-Angle Glaucoma. San Francisco, CA: American Academy of Ophthalmology (2017). Available at <http://www.aao.org> (accessed May 31, 2018).

16. Clinical Trial- Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug (NCT01800175). Ocular Therapeutix. Available at <www.clinicaltrials.gov> (accessed May 31, 2018).

17. Brandt JD1, Six-Month Intraocular Pressure Reduction with a Topical Bimatoprost Ocular Insert: Results of a Phase II Randomized Controlled Study. Ophthalmology. 2016 May 5. PMID 27157843

Policy History:

DateReason
7/15/2018 Document updated with literature review. No change in coverage. Added references 5, 6, 12, 13.
4/15/2017 Reviewed. No changes.
7/1/2016 Document updated with literature review. The following change was made to Coverage: Added drug-eluting ocular inserts as considered experimental, investigational and/or unproven. Title changed from “Drug-Eluting Intracanalicular Punctal Plugs”.
9/15/2015 Reviewed. No changes.
7/1/2014 New medical document A drug-eluting intracanalicular punctal plug is considered experimental, investigational and/or unproven.

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