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Ocriplasmin (Jetrea) (125 mcg Intravitreal Injection): For the Treatment of Symptomatic Vitreomacular Adhesion [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2014 Jan.

3RESULTS

3.1. Findings from the Literature

A total of three studies were identified from the literature for inclusion in the systematic review (Figure 1). The included studies are summarized in Table 3.

Figure 1. QUOROM Flow Diagram for Inclusion and Exclusion of Studies.

Figure 1

QUOROM Flow Diagram for Inclusion and Exclusion of Studies. QUOROM = Quality of Reporting of Meta-analyses.

Table 3. Details of Included Studies.

Table 3

Details of Included Studies.

3.2. Included Studies

3.2.1. Description of Studies

Three multicentre, randomized, parallel group, double-mask, placebo and sham controlled studies met the inclusion criteria for this systematic review. TG-MV-006 (N = 326) and TG-MV-007 (N = 326) are identically designed phase III studies which evaluated the safety and efficacy of a single 125 mcg dose injection of ocriplasmin compared with placebo injection for the treatment of sVMA (focal VMA leading to symptoms).

TG-MV-004 (N = 60) is a phase II study, which evaluated the safety and preliminary efficacy of ocriplasmin 75 mcg, 125 mcg, and 175 mcg single doses and repeated doses of ocriplasmin 125 mcg (up to two additional open-label injections) compared with a sham injection. Although TG-MV-004 met the inclusion criteria for this report, the study comprised a small sample size that was likely not sufficiently powered to detect differences in resolution of VMA, as it was a secondary end point and was analyzed in an exploratory manner. Furthermore, the primary analyses were pre-specified to pool data from the 125 mcg single-dose group with the treatment group, which received more than one dose of ocriplasmin 125 mcg; ocriplasmin is indicated for a single dose only. Given these important limitations of TG-MV-004, data from this study are not presented. Thus, the two pivotal phase III studies, TG-MV-006 and TG-MV-007, are the focus of this report.

Patients in both TG-MV-006 and TG-MV-007 were followed for 6 months. The allocation ratio was 2:1 (ocriplasmin:placebo) in TG-MV-006 and 3:1 in TG-MV-007. In both studies, patients in the treatment group received a single 0.1 mL intravitreal injection containing the study drug and 0.75 mL normal saline, while patients in the placebo group received only the intravitreal injection of the normal saline solution. The studies consisted of seven visits: baseline, injection day, post-injection day 7, post-injection day 14, post-injection day 28 (primary outcome assessment), post-injection month 3, and post-injection month 6.

3.2.2. Populations

a. Inclusion and Exclusion Criteria

The main inclusion criteria in TG-MV-006 and TG-MV-007 were patients 18 years of age or older with a presence of sVMA (i.e., central vitreal adhesion within 6 mm optical coherence tomography [OCT] field surrounded by elevation of the posterior vitreous cortex) related to decreased visual function as per the opinion of the investigator. Patients must have had a BCVA of 20/25 or worse in the study eye, and BCVA of 20/800 in the non-study eye. Both eyes were examined; the eye with the worst BCVA was selected as the study eye if both eyes met the inclusion criteria.

A patient was excluded from the studies if he or she had had previous treatment with intravitreal injections in the past three months in the study eye, rhegmatogenous retinal detachment in either eye, proliferative diabetic retinopathy, neovascular age-related macular degeneration (AMD), retinal vascular occlusion, aphakia, high myopia (greater than −8 diopters), uncontrolled glaucoma, MH > 400 mcm in diameter, vitreous opacification, or lenticular/zonular instability.

b. Baseline Characteristics

Baseline characteristics were generally well balanced across treatment groups in both studies (Table 4). Patients had a mean age of approximately 71 years and most (~65%) were female. The majority of patients were Caucasian (~92%), had VMA with a diameter of 1,500 mcm or smaller (~70%), and had an expected need for vitrectomy (~83%). Approximately 24% of patients had a baseline diagnosis of full-thickness macular hole (FTMH) and approximately 76% of patients had a baseline diagnosis of vitreomacular traction (VMT), including diabetic retinopathy. None of the patients, with the exception of one in the ocriplasmin group in TG-MV-006, had total posterior vitreous detachment (PVD) at baseline. The mean baseline BCVA letter scores ranged from 63.4 to 65.3 in both studies.

Table 4. Summary of Baseline Characteristics — TG-MV-006 and TG-MV-007.

Table 4

Summary of Baseline Characteristics — TG-MV-006 and TG-MV-007.

3.2.3. Outcomes

The primary outcome in TG-MV-006 and TG-MV-007 was the proportion of patients with VMA resolution, determined by masked central reader center (CRC) by OCT at day 28. OCT measurements were made by a certified assessor of patients after dilating the pupil. Patients who experienced anatomical defects such as retinal holes or retinal detachments, resulting in vision loss, were considered treatment failures for the primary outcome. Success on the primary end point was defined as per the CRC OCT interpretation document, which was finalized prior to unmasking (Table 5). VMA was defined by categories 1, 2, and 4.

Table 5. Vitreomacular Adhesion Status Categories.

Table 5

Vitreomacular Adhesion Status Categories.

Table 6. Resolution of Vitreomacular Adhesion Progression Status Categories.

Table 6

Resolution of Vitreomacular Adhesion Progression Status Categories.

Secondary outcomes of interest included the proportion of patients with total PVD at day 28, as determined by masked investigator assessment of B-scan ultrasound; non-surgical closure of FTMH at day 28 and 6 months, evaluated during the masked CRC review of the OCTs; the proportion of patients who received vitrectomy at day 28 and 6 months; and change in baseline BCVA at day 28 and 6 months, measured as the proportion of patients achieving greater than 15 letters (3 lines) improvement or worsening in BCVA from baseline, without the need for vitrectomy. Severe vision loss (a loss of > 30 letters in BCVA) from baseline was also an outcome of interest.

VA was measured using Prevision Vision’s backlit Early Treatment Diabetic Retinopathy Study (ETDRS) charts that were set four metres away from the patient. A 12 mm vertex distance was set by a phoropter to obtain manifest refraction measurements. A patients was retested at 1 metre (following instructions provided for 1-metre testing) if he or she was unable to read 20 or more letters on the ETDRS chart at 4 metres.

Health-related quality of life (HRQoL) was measured using the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25). Specifically, the general health subscale and the composite score were the primary indicators of HRQoL. Changes from baseline in the general health subscale and composite scores were measured at six months.

Adverse events (AEs) were considered as events with an onset on or after the time of study drug injection. Serious adverse events (SAEs) were defined as an AE that either resulted in death, was immediately life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, or as a congenital anomaly or birth defect. Other safety outcomes of interest included lens subluxation, cataracts, eye infection, retinal detachment, vitritis, conjunctival hemorrhage, retinal hemorrhage, and vitreous hemorrhage

3.2.4. Statistical Analysis

a. Efficacy Criteria

The sample size for TG-MV-006 and TG-MV-007 was calculated assuming an event rate of 27.5% in the 125 mcg dose group and 10% in the placebo group. A total of 320 participants were expected to be sufficient to achieve 90% power with a two-sided significance level of 5%. The calculation was applied for a randomization ratio of 3:1, which was used in TG-MV-007. The original randomization ratio was also 3:1 in TG-MV-006, but was changed to 2:1 before the commencement of the study as per a recommendation by the United States Food and Drug Administration.36

The analysis for the primary end point (resolution of VMA) and key secondary end points (total PVD detachment, non-surgical closure of FTMH) was performed using the full analysis set (FAS) population, using the last observation carried forward (LOCF) approach for missing observations. The proportion of patients who had resolution of VMA was compared by treatment group using Fisher’s exact test. In TG-MV-006, the primary end point analyses were adjusted for the randomization ratios as 3:1 or 2:1 using conditional logistic regression (with randomization ratio as the factor for stratification) and Cochran-Mantel-Haenszel tests. The per-protocol (PP) population was used for supportive efficacy analyses.

Secondary analyses were calculated using the FAS with observed case approach, with missing data for any reason excluded. Other than the secondary end point for the proportion of patients with total PVD, no adjustments for multiple comparisons/end points were made for the secondary end points. The proportions of patients who had total PVD, who had non-surgical closure of FTMHs, who received vitrectomy, and categorical changes (improvement or worsening of ≥ 15 and ≥ 30 letters) in BCVA score, were compared by treatment group using Fisher’s exact test. Mean changes in BCVA letter scores were calculated using the Wilcoxon rank-sum test, comparing change from baseline between-treatment groups. Patients with total PVD at baseline were included as failures. Patients who achieved total PVD at two consecutive visits did not require an additional B-scan ultrasound at subsequent visits; thus, patients who had missing data at day 28 were considered successes if they had total PVD at day 7 and day 14.

Two subgroup analyses for resolution of VMA at day 28 were established a priori and performed for patients with and without FTMH determined by the CRC at baseline, and by baseline VA category. A post-hoc subgroup analysis for resolution of VMA at day 28 by age group (patients ≥ 65 years of age and < 65 years of age) was performed. A sensitivity analysis using a multiple imputation method for missing data for the resolution of VMA and the proportion of patients with total PVD was performed. Based on the conditional probabilities of success or failure using observed probabilities within the study, missing data were imputed with results using 100 iterations.

c. Analysis Populations

In TG-MV-006 and TG-MV-007, the following data sets were defined:

Full Analysis Set

All patients randomized to receive study medication (ocriplasmin and placebo). The full analysis set (FAS) was the primary population for all analyses.

Modified Full Analysis Set (FAS in patients with VMA)

FAS in patients with VMA included all patients who received treatment with the investigational drug and who were judged by the investigator as having sVMA at screening, which was confirmed by masked CRC OCT evaluation at baseline. The modified FAS (mFAS) excluded patients with either no or undetermined focal VMA status at baseline. Patients without VMA at baseline, by definition, had no possibility of being a success on the primary end point of VMA resolution. This population was of secondary importance and was utilized to determine the most accurate point estimate of event rates in both the active and placebo groups.

Per-protocol set

A subset of the FAS population that excluded patients with a protocol deviation that was of sufficient concern to warrant exclusion.

Safety data set

Patients in the FAS population who were randomized and received treatment. Patients were counted in the group in which they were actually treated.

3.3. Patient Disposition

Patient disposition is summarized in Table 7. A total of 326 patients in TG-MV-006 and 326 patients in TG-MV-007 were randomized. Overall, the number of premature discontinuations in both studies was low. In TG-MV-006, discontinuation was similar between both groups with rates of 8.7% and 8.4% for the ocriplasmin and placebo groups respectively. In TG-MV-007, discontinuation was lower among the ocriplasmin group (4.1%) compared with the placebo group (8.6%). Reasons for discontinuation were generally similar in all treatment arms, with the exception of three deaths in TG-MV-006 and one death in TG-MV-007.

Table 7. Patient Disposition.

Table 7

Patient Disposition.

3.4. Exposure to Study Treatments

In both studies, on day 0, all patients in the Safety Sets received a single intravitreal injection, administered using either a 30G or 27G-size needle, of ocriplasmin 125 mcg or matching placebo of equal volume.

3.5. Critical Appraisal

3.5.1. Internal Validity

a. Selection, Allocation, and Disposition of Patients

  • Both studies were randomized and double-masked.
  • The studies employed appropriate methods of allocation concealment. Patients were randomized centrally through a telephone-based, interactive voice response system (IVRS) to either ocriplasmin or placebo. Study personnel called IVRS on the day of the study and were informed which vial number to use for the patient’s injection. Vials containing placebo were identical in appearance, having the same components and concentrations without the ocriplasmin.
  • Baseline characteristics of both the ocriplasmin and placebo groups were generally similar in both studies. In study TG-MV-006, there was a greater proportion of individuals with FTMH and a smaller proportion of patients with VMT with an expected need for vitrectomy.
  • One patient was inadvertently treated with ocriplasmin after being randomized to receive placebo; this was unlikely to have influenced the efficacy results.
  • In both studies, the proportion of patients who discontinued was generally low and similar in all treatment groups with the exception of the ocriplasmin group in TG-MV-007, which, for an unknown reason, had fewer withdrawals (approximately half the proportion of the other treatment groups).

b. Intervention and Comparator

  • A placebo injection instead of sham injection was used as the comparator treatment in both studies. Based on discussion with the clinical expert involved in the review, insertion of a needle and administration of saline may affect the natural history of VMA, including precipitating vitreous detachment. Moreover, placebo injection (versus sham injection where no needle is inserted into the eye) may increase the likelihood of causing SAEs, such as serious ocular infections and retinal detachment. However, these concerns are somewhat mitigated by the much larger (and statistically significant) rate of VMA resolution at day 28 in favour of ocriplasmin versus placebo in both studies, and the very low rate of eye infection and retinal detachment in the placebo group in both studies.
  • Although subgroup analyses for the primary end point among patients with and without FTMH at baseline and by baseline VA category were established a priori, analyses of two other subgroups of interest (≥ 65 years of age and < 65 years of age) were performed post hoc. It was unlikely that there was sufficient statistical power to detect differences in the primary end point among these subgroups and randomization would have been broken.
  • Other than the secondary end point of total PVD at 28 days, the authors did not adjust for the multiplicity of additional secondary end points. The authors stated that the additional secondary end points were of a supportive nature only and were interpreted as such.
  • The use of LOCF in the context of the differential withdrawal rates could have biased the FAS results of the primary end point among the ocriplasmin group in TG-MV-007. However, this concern is mitigated to an extent by the fact that the multiple imputation sensitivity analysis (Table 18) and per protocol set (PPS) results (Table 15) were consistent with the FAS.

3.5.2. External Validity

a. Patient Characteristics

  • The FAS included a small proportion of patients who did not have VMA as determined by masked CRC OCT evaluation at baseline. Therefore, the FAS comprised patients who, by definition, had no possibility of achieving the primary end point of VMA resolution. The mFAS was considered to be a secondary efficacy population, as it did not contain enough patients, thereby lacking statistical power according to the sample size calculation.
  • With only one extension study (TG-MV-012) with a small sample size (N = 24) assessing patients approximately 2.5 years after initial intravitreal injection (Appendix 6: SUMMARY OF FOLLOW-UP STUDY TG-MV-012), there is limited long-term efficacy and safety data for ocriplasmin.
  • With no head-to-head trials comparing ocriplasmin with “watchful waiting” or vitrectomy alone, ocriplasmin could not be compared with other current treatments used in Canada for VMA.
  • The generalizability of the findings is somewhat limited by specific inclusion and exclusion criteria. For example, participants were excluded — in part — based on specific baseline BCVA scores; hence, the study populations were not wholly inclusive of all patients with VMA. However, this limitation is somewhat mitigated given the broad criteria of including patients with BCVA scores of ≤ 20/25 in the study eye and ≥ 20/800 in the non-study eye.

3.6. Efficacy

Only those efficacy outcomes identified in the review protocol are reported below (Section 2.2, Table 2).

3.6.1. Prevention of Blindness

Prevention of blindness was not evaluated in TG-MV-006 and TG-MV-007.

3.6.2. Resolution of Vitreomacular Adhesion

Results for resolution of VMA are summarized in Table 8 for the FAS population. In both studies, ocriplasmin revealed statistical superiority over placebo for the achievement of VMA at day 28, 3 months, and 6 months. At day 28, the percentage of patients achieving VMA resolution were 27.9% and 25.3% in the ocriplasmin groups, and 13.1% and 6.2% in the placebo groups for TG-MV-006 and TG-MV-007 respectively. The between-group difference of patients achieving resolution of VMA with ocriplasmin versus placebo was greater in TG-MV-007 (19.1%) compared with TG-MV-006 (14.8%). Similar results were seen at 3 months and 6 months. The proportion of patients who achieved resolution of VMA was similar at all follow-up periods for the ocriplasmin groups in both studies (Figure 2). In TG-MV-006, the placebo group had a greater proportion of patients achieving resolution of VMA at day 28, 3 months, and 6 months compared with TG-MV-007. Results for resolution of VMA were consistent among all analysis populations (FAS, mFAS, and PP) (Table 15).

Table 8. Resolution Of Vma — Full Analysis Set.

Table 8

Resolution Of Vma — Full Analysis Set.

Figure 2. Proportion of Patients With Resolution of VMA, by Length of Follow-Up.

Figure 2

Proportion of Patients With Resolution of VMA, by Length of Follow-Up. VMA = vitreomacular adhesion. Source: Figure adapted from data in Clinical study report TG-MV-006 and clinical study report TG-MV-007.

Results from the sensitivity analysis using a multiple imputation method for missing data were consistent with between-group differences of 13.5% (95% confidence interval [CI], 4.3 % to 22.7%) and 19.2% (95% CI, 10.5 % to 27.8%) at day 28 for TG-MV-006 and TG-MV-007 respectively (Table 18).

Subgroup analyses for resolution of VMA, performed for patients with and without FTMH at baseline, by baseline VA category (ETDRS score > 60, > 65 and > 70 letters) and by age group (≥ 65 years of age and < 65 years of age), are summarized in Table 9 and Table 10. Among patients with FTMH, the between-group difference of patients achieving resolution of VMA with ocriplasmin versus placebo at day 28 was 33.1% (95% CI, 8.5% to 57.7%) in TG-MV-007. The between-group difference of patients achieving resolution of VMA among patients with FTMH was not statistically significant in TG-MV-006. Among patients without FTMH, the between-group difference of patients achieving resolution of VMA with ocriplasmin versus placebo at day 28 was 14.3% (95% CI, 5.9 % to 22.8%) in TG-MV-006 and 15.3% (95% CI, 8.5% to 22.2%) in TG-MV-007.

Table 9. Vitreomacular Adhesion Resolution at Day 28 for TG-MV-006 and TG-MV-007 — Subgroup Analyses, Full Analysis Set.

Table 9

Vitreomacular Adhesion Resolution at Day 28 for TG-MV-006 and TG-MV-007 — Subgroup Analyses, Full Analysis Set.

Table 10. Vitreomacular Adhesion Resolution at Day 28 by Baseline BCVA Subgroup — Full Analysis Set.

Table 10

Vitreomacular Adhesion Resolution at Day 28 by Baseline BCVA Subgroup — Full Analysis Set.

Among patients with a baseline VA of > 60 letters, ocriplasmin was statistically superior to placebo with a between-group difference of 20.8% (95% CI, 5.0% to 36.7%) in TG-MV-006 and 23.9% (95% CI, 8.7% to 39.1%) in TG-MV-007. For patients with a baseline VA of > 65 letters, ocriplasmin was statistically superior to placebo with a between-group difference of 17.7% (95% CI, 4.0% to 31.3%) in TG-MV-006 and 27.3% (95% CI, 15.9% to 38.7%) in TG-MV-007. In TG-MV-006, the between-group difference of patients with a baseline VA of > 70 letters was 16.3% (95% CI, 3.5% to 29.1%). In TG-MV-007, the results for patients with a baseline VA of > 70 letters favoured the ocriplasmin group, although the results were not statistically significant.

Among patients ≥ 65 years of age, ocriplasmin was statistically superior to placebo with a between-group difference of 13.1% (95% CI, 4.7% to 21.4%) in TG-MV-006 and 18.8% (95% CI, 11.1% to 26.5%) in TG-MV-007. The results for patients < 65 years of age favoured the ocriplasmin groups, although the results were not statistically significant.

3.6.3. Health-related quality of life

Results for HRQoL are summarized in Table 11. Statistically significant results were observed only in TG-MV-007 for the VFQ-25 composite score. At six months, the ocriplasmin group had a greater mean (standard deviation [SD]) change from baseline in composite score (3.3 [11.97]) compared with the placebo group (−0.1 [10.29]), (P = 0.013).

Table 11. Change in Health-Related Quality of Life at Six Months — Full Analysis Set.

Table 11

Change in Health-Related Quality of Life at Six Months — Full Analysis Set.

3.6.4. Total posterior vitreous detachment

Results for patients who achieved total PVD at day 28 are summarized in Table 12. Patients in the ocriplasmin groups revealed greater achievement of total PVD at day 28 in both studies, with a between-group difference of 9.9% (95% CI, 3.1% to 16.7%) in TG-MV-006 and 10.6% (95% CI, 6.8% to 14.5%) in TG-MV-007.

Table 12. Other Efficacy Outcomes — Full Analysis Set.

Table 12

Other Efficacy Outcomes — Full Analysis Set.

3.6.5. Non-surgical closure of full-thickness macular holes

Results for patients who achieved non-surgical closure of FTMHs are summarized in Table 12. At day 28, the ocriplasmin groups were statistically superior to placebo for the achievement of non-surgical closure of FTMH, with a between-group difference of 31.4% (95% CI, 14.1% to 48.6%) in TG-MV-006 and 30.1% (95% CI, 11.6% to 48.6%) in TG-MV-007. At six months, similar results were seen, though statistical significance was only reached in TG-MV-006, with a between-group difference of 30.0% (95% CI, 11.9% to 48.0%).

3.6.6. Proportion of patients receiving vitrectomy

Results for patients who received vitrectomy are summarized In Table 12. In both studies, the proportion of patients receiving vitrectomy was greater in the placebo groups compared with the ocriplasmin group at day 28 and 6 months, though differences were not statistically significant.

3.6.7. Change from baseline in best-corrected visual acuity

Results for categorical changes (≥ 15 and ≥ 30 letters) in BCVA from baseline and mean BCVA letter scores from baseline are summarized in Table 13. The proportion of patients who had an improvement of 15 letters or more at 6 months was greater in the ocriplasmin group compared with placebo in TG-MV-007, with a between-group difference of 8.1% (95% CI, 2.3% to 13.9%). The between-group difference for patients achieving an improvement of 15 letters or more in BCVA at 6 months was not statistically significant in TG-MV-006. In both studies, no statistically significant differences were observed for improvement or worsening of 15 letters or more at day 28, worsening of 15 letters or more at 6 months, improvement of 30 letters or more, and worsening of 30 letters or more at day 28 and 6 months. Change in mean BCVA ETDRS letters scores at day 28 and 6 months were not statically significant.

Table 13. Changes in Visual Acuity — Full Analysis Set.

Table 13

Changes in Visual Acuity — Full Analysis Set.

3.7. Harms

Only those harms identified in the review protocol are reported below (2.2.1, Protocol). See Appendix 4: DETAILED OUTCOME DATA for detailed harms data.

3.7.1. Adverse Events

In both studies, the overall incidence of AEs was greater among the ocriplasmin groups compared with placebo. A total of 42.3% and 38.0% of patients in the ocriplasmin groups experienced at least one treatment-emergent AE compared with 19.8% and 23.5% of patients receiving placebo in TG-MV-006 and TG-MV-007 respectively. The most common AEs included vitreous floaters, photopsia, vision loss, and eye pain (Table 14).

Table 14. Summary of Harms.

Table 14

Summary of Harms.

3.7.2. Serious Adverse Events

The incidence of SAEs was similar between ocriplasmin and placebo in TG-MV-006 (14.5% versus 12.3% respectively) and in TG-MV-007 (13.5 % versus 13.6% respectively). In general, the incidence of individual SAEs was low. The most common SAEs were macular hole, maculopathy, retinal detachment, vitreous adhesion, and reduction in visual acuity (Table 14).

3.7.3. Withdrawals Due to Adverse Events

Table 14 summarizes withdrawals due to adverse events (WDAEs). Overall incidence of WDAEs was low and similar between the ocriplasmin and placebo groups (0.9% versus 1.9% in TG-MV-006 respectively). In TG-MV-007, the proportion of patients experiencing WDAEs was 0.8% in the ocriplasmin group, with no WDAEs occurring in the placebo group.

3.7.4. Mortality

There were three deaths (1.4%) in the ocriplasmin group in TG-MV-006 and one death (0.4%) in the ocriplasmin groups in TG-MV-007. There were no deaths in the placebo groups. According to the investigators, the deaths were not considered related to the study drug according to the investigators (Table 14).

3.7.5. Notable Harms

In discussion with the clinical expert involved in the review, the CDR reviewers identified a priori several AEs of interest: lens subluxation, cataracts, eye infection, retinal detachment, vitritis, conjunctival hemorrhage, retinal hemorrhage, and vitreous hemorrhage. There were no events of lens subluxation reported in either study. The incidence of AEs was generally low and similar between the ocriplasmin and placebo groups in TG-MV-006 and TG-MV-007 respectively: cataracts (2.7% versus 4.7% and 2.4% versus 3.7%); retinal detachment (1.4% versus 1.9% and 0.4% versus 1.2%); retinal hemorrhage (1.8% versus 1.9% and 1.6% versus 2.5%); and vitreous hemorrhage (0.9% versus 1.9% and 0.8% versus 1.2%). Conjunctival hemorrhage (15.5% versus 13.2% and 13.9% versus 12.3%) was also similar between ocriplasmin and placebo in TG-MV-006 and TG-MV-007 respectively. There was one eye infection (0.9%) in the placebo group of TG-MV-006, one eye infection (0.4%) in the ocriplasmin group of TG-MV-007, and one event of vitritis (0.4%) in the ocriplasmin group of TG-MV-007.

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Ocriplasmin (Jetrea) (125 mcg Intravitreal Injection): For the Treatment of Symptomatic Vitreomacular Adhesion [Internet].

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