Symptomatic Vitreomacular Adhesion Research Articles

Resolution of outer retinal abnormalities in eyes with vitreomacular traction without macular hole in the OASIS trial

Background/aimsTo describe the clinical impact of external limiting membrane (ELM) disruption, ellipsoid zone (EZ) disruption and subretinal fluid (SRF) seen on optical coherence tomography (OCT) in eyes with vitreomacular traction...

The Effect of Intravitreal Ocriplasmin on Hue Discrimination.

We report 13 patients who received ocriplasmin for symptomatic vitreomacular adhesion. Farnsworth-Munsell 100 (FM 100) hue test total error score (TES) increased from baseline to month 1, before recovering at year 1. Ocriplasmin may alter hue discrimination. This study aimed to determine whether intravitreal ocriplasmin affects hue discrimination. Thirteen patients with symptomatic vitreomacular adhesion received intravitreal ocriplasmin 125 μg. Patients underwent full ocular examination, optical coherence tomography, and FM 100 hue test at baseline, 1 week, 1 month, and 1 year. Mean age was 74.8 years. The median baseline FM 100 TES was similar in the injected and fellow eyes (272 vs. 252, respectively). Median TES in the injected eye increased from 272 to 348 at 1 week (median difference compared with baseline, +52.0; 98.8% confidence interval of difference, -64.0 to 184.0; P = .29), decreased to 324 at 1 month (median difference compared with baseline, -4.0; 98.8% confidence interval of difference, -44.0 to 256.0; P = .40), and decreased to 268 at 1 year (median difference compared with baseline, -108.0; 93.8% confidence interval of difference, -200.0 to 52.0; P = .19). Two patients (15.4%) had anatomic release of vitreomacular adhesion, occurring within 1 month of injection. Ocriplasmin may alter hue discrimination, but larger studies are required to provide sufficient power to detect or exclude a statistically significant effect. Longer follow-up is needed to determine the duration of any effect.

Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial

Background/aimsOASIS is a Phase IIIb trial (NCT01429441) assessing long-term outcomes in subjects with symptomatic vitreomacular adhesion (VMA). The purpose of this study is to report on the frequency, severity, location...

Prognostic Factors Associated with Ocriplasmin Efficacy for the Treatment of Symptomatic Vitreomacular Adhesion and Full-thickness Macular Hole: Analysis from Four Studies.

PurposeTo assess the effect of patient baseline characteristics on the efficacy of ocriplasmin treatment for symptomatic vitreomacular adhesion (VMA) with full-thickness macular hole (FTMH) from phase 3/4 studies.MethodsPatients with symptomatic VMA and FTMH at baseline and receiving ocriplasmin treatment 125 g were pooled from the MIVI-TRUST, OASIS, and ORBIT studies. Multivariable logistic regression analysis was used to evaluate whether patient baseline characteristics were predictors of having VMA resolution by Day 28 and FTMH closure by Month 6.ResultsTwo hundred and seventy-four patients receiving ocriplasmin treatment were assessed. Overall, 22.6% (62/274) of the patients experienced both VMA resolution by Day 28 and non-surgical FTMH closure by Month 6. Patients with FTMH 250 µm at baseline had a significantly higher success rate compared to those with FTMH 400 µm (29.9% [41/137] vs 2.2% [1/48]; P = 0.009). In patients with VMA resolution by Day 28, both small FTMH size (P = 0.001) and FTMH width at RPE (P = 0.012) were significantly associated with a higher FTMH closure rate. Patients with VMA resolution had higher rates of FTMH closure. Previously identified baseline predictive factors, including age, lens status, or presence of epiretinal membrane (ERM) were not found to be predictive of both VMA release and FTMH closure.ConclusionThe analysis revealed that FMTH 250 µm was the only factor predictive for achieving both pharmacological VMA resolution by Day 28 and nonsurgical FTMH closure by Month 6; neither lens status or presence of ERM, previously identified baseline characteristics favoring VMA resolution, showed statistically significant predictive power for both outcomes.

Mutational Analysis of Ocriplasmin to Reduce Proteolytic and Autolytic Activity in Pichia pastoris

BackgroundOcriplasmin (Jetrea) is using for the treatment of symptomatic vitreomacular adhesion. This enzyme undergoes rapid inactivation and limited activity duration as a result of its autolytic nature after injection within the eye. Moreover, the proteolytic activity can cause photoreceptor damage, which may result in visual impairment in more serious cases.ResultsThe present research aimed to reduce the disadvantages of ocriplasmin using site-directed mutagenesis. To reduce the autolytic activity of ocriplasmin in the first variant, lysine 156 changed to glutamic acid and, in the second variant for the proteolytic activity reduction, alanine 59 mutated to threonine. The third variant contained both mutations. Expression of wild type and three mutant variants of ocriplasmin constructs were done in the Pichia pastoris expression system. The mutant variants were analyzed in silico and in vitro and compared to the wild type. The kinetic parameters of ocriplasmin variants showed both variants with K156E substitution were more resistant to autolytic degradation than wild-type. These variants also exhibited reduced Kcat and Vmax values. An increase in their Km values, leading to a decreased catalytic efficiency (the Kcat/Km ratio) of autolytic and mixed variants. Moreover, in the variant with A59T mutation, Kcat and Vmax values have reduced compared to wild type. The mix variants showed the most increase in Km value (almost 2-fold) as well as reduced enzymatic affinity to the substrate. Thus, the results indicated that combined mutations at the ocriplasmin sequence were more effective compared with single mutations.ConclusionsThe results indicated such variants represent valuable tools for the investigation of therapeutic strategies aiming at the non-surgical resolution of vitreomacular adhesion.

Full-Thickness Macular Hole and Symptomatic Vitreomacular Adhesion: Comparison of Visual Results in Patients Receiving Pars Plana Vitrectomy in One Eye and Ocriplasmin in the Fellow Eye

Purpose: This article compares bilateral visual outcomes in patients receiving a vitrectomy in one eye for a full-thickness macular hole (FTMH) who also received ocriplasmin treatment in the fellow eye for symptomatic vitreomacular adhesion (VMA). Methods: This was a multicenter, retrospective study to assess the difference in best-corrected visual acuity (BCVA) in patients receiving a vitrectomy in the eye with an FTMH and ocriplasmin treatment for the fellow eye with symptomatic VMA but no FTMH. Patients initially received either a single injection of ocriplasmin 0.125 mg for symptomatic VMA or a vitrectomy for FTMH. After the first eye was stable following the initial treatment option, the second eye was treated with the opposite modality. BCVA was measured at baseline, month 3, and month 6, with up to 2 years of additional follow-up. Results: Thirty-six eyes (18 patients) were included in the analysis. Eyes that underwent a vitrectomy for FTMH had a mean baseline BCVA of 20/123 and a final BCVA of 20/53. Eyes receiving ocriplasmin treatment for VMA had a mean baseline BCVA of 20/49 and a final BCVA of 20/33. The median time between the 2 treatments was 5.5 months. Eyes receiving ocriplasmin had a median time to VMA resolution of 4 weeks. Conclusions: Treatment with ocriplasmin showed successful resolution of VMA and improvement in BCVA, obviating the need for vitrectomy. The current study provides a framework for the treatment of patients with a current FTMH in one eye and VMA without an FTMH in the contralateral eye.

This issue of Acta

This issue of Acta

Budget impact analysis of ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the USA.

Vitreomacular traction (VMT) treatment options include watchful waiting, vitrectomy and intravitreal ocriplasmin injection (Jetrea®). This analysis used results from the recently completed OASIS randomized clinical trial to evaluate the 2-year budget impact of ocriplasmin injection availability for treatment of Stage I or II VMT without epiretinal membrane formation in a modeled US health plan. VMT prevalence, treatment patterns and disease resolution rates were from literature, a US retinal-specialist survey and the OASIS trial. Medicare payment rates were applied and a national scenario analysis was conducted. With ocriplasmin available, vitrectomy use and complications-related costs decreased. Budget impact of ocriplasmin to the health plan was US$143,599 over 2 years or US$0.0060 per-member per-month. Ocriplasmin was projected to be minimally cost-additive at US$0.0060 per-member per-month over 2 years.

Ocriplasmin Treatment Leads to Symptomatic Vitreomacular Adhesion/Vitreomacular Traction Resolution in the Real-World Setting: The Phase IV ORBIT Study

To evaluate clinical outcomes and safety up to 12 months after ocriplasmin injection for the treatment of patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) in a real-world setting. The Phase IV Ocriplasmin Research to Better Inform Treatment (ORBIT) trial (NCT02079883) was a Phase IV multicenter, prospective, observational study. Patients aged ≥18 years with symptomatic VMA/VMT treated with ocriplasmin. Patients received a single 0.125 mg intravitreal injection of ocriplasmin. All assessments and treatment decisions were at the discretion of the treating physician. Spectral-domain OCT (SD-OCT) images were analyzed by an independent central reading center (CRC). All enrolled patients were included in demographic, baseline characteristics, and safety analyses. Patients with symptomatic VMA/VMT at baseline determined by CRC were included in baseline ocular characteristics and efficacy analyses. Clinical outcomes were measured up to 12 months and included resolution of symptomatic VMA, closure of full-thickness macular hole (FTMH), mean change from baseline in best-corrected visual acuity (BCVA), incidence of vitrectomy, and time to first vitrectomy. Safety outcomes included the incidence and timing of onset of adverse drug reactions (ADRs). Of the 539 patients enrolled, 480 were determined to have symptomatic VMA/VMT at baseline post-CRC assessment. After treatment with ocriplasmin, the rate of VMA/VMT resolution was 45.8% (95% confidence interval [CI], 41.3-50.4) at month 1 and 59% (95% CI, 54.4-63.4) at months 10 to 12. The rate of FTMH closure was 30.5% (95% CI, 22.4-39.7) at month 1 and 32.2% (95% CI, 23.9-41.4) at months 10 to 12. Mean (standard deviation) change from baseline in BCVA was 1.5 (11.19) letters at month 1 and 5.2 (13.60) letters at months 10 to 12. Vitrectomy was performed in 28.5% of patients, with a median time to vitrectomy of 63 days. Adverse drug reactions were reported by 30.6% of patients; 5.2% experienced a serious ADR. Results from the ORBIT study demonstrate that treatment with ocriplasmin is effective and well tolerated in patients with symptomatic VMA/VMT in a real-world setting. The percentage of patients with VMA/VMT resolution at month 1 was higher than previously reported in well-controlled clinical trials. No new safety signals were identified.

Subfoveal Lucency after Treatment of Vitreomacular Traction without Macular Hole in the Phase 3 Trials of Ocriplasmin Vitreolysis

To describe the clinical impact of subfoveal lucency (SFL) seen on OCT before and after treatment of vitreomacular traction (VMT) or symptomatic vitreomacular adhesion (VMA) without macular hole (MH) in the prospective phase 3 trials of ocriplasmin vitreolysis. Randomized double-blind placebo-controlled multicenter study. Four hundred ninety-nine eyes with VMT or VMA without MH. Eyes were randomized to either a single intravitreal injection of ocriplasmin or placebo treatment and were followed up for 6 months. Eyes were analyzed for presence, dimensions, and course of SFL on OCT, release of VMT, and their effect on visual acuity (VA). Among eyes without baseline SFL, new SFL was more frequent after ocriplasmin than placebo at week 1 (23.1% vs. 6.54%; P= 0.0002) and week 2 (19.7% vs. 3.85%; P= 0.0001), but was similar in frequency by week 4 (8.37% vs. 7.69%; P= 0.83). Six-month VA for eyes demonstrating SFL after ocriplasmin during the first 2 weeks was comparable with those without SFL at any point in the study (P= 0.12). In placebo-treated eyes but not ocriplasmin-treated eyes, SFL was associated with worse VA at all visits. The increase in SFL width from baseline to week 2 was significantly greater with ocriplasmin than placebo (P= 0.029). Among ocriplasmin-treated eyes at month 6, those with SFL and VMT release had better VA than those with SFL and persistent adhesion (P= 0.037) and similar VA to those with persistent adhesion without SFL (P= 0.17). In the placebo group, those with baseline SFL showed low rates of spontaneous VMT release at month 6 compared with those without baseline SFL (3/21 eyes vs. 33/99 eyes; P= 0.045). Compared with placebo, SFL occurred more frequently only in the initial weeks after treatment with ocriplasmin. When SFL developed after ocriplasmin administration, VA was not impacted at the 6-month visit. Persistent SFL in ocriplasmin-treated eyes at month 6 was associated with poorer vision if VMT had not released. Eyes with SFL at baseline had low rates of spontaneous VMT release and may need treatment.

What are the effects of ocriplasmin for people with symptomatic vitreomacular adhesion?

What are the effects of ocriplasmin for people with symptomatic vitreomacular adhesion?

INTRAVITREAL OCRIPLASMIN IN CLINICAL PRACTICE: Predictors of Success, Visual Outcomes, and Complications.

To investigate predictors of success, visual outcomes, and complications of intravitreal ocriplasmin for the treatment of symptomatic vitreomacular adhesion in a clinical care setting. Retrospective chart review of 49 consecutive eyes of 47 patients who received intravitreal ocriplasmin. Spectral domain optical coherence tomography scans were examined for vitreomacular traction (VMT) release, full-thickness macular hole (FTMH) closure, and other changes in retinal anatomy. Pharmacologic VMT release occurred in 41% of eyes; positive predictors included age ≤75 years (P = 0.001), phakic status (P = 0.016), VMT width ≤750 μm (P = 0.001), and absence of retinal comorbidities (P = 0.035). Pharmacologic FTMH closure occurred in 25% of cases; positive predictors included successful VMT release (P = 0.042), better preinjection best-corrected visual acuity (P = 0.036), and smaller FTMH aperture width (P = 0.033). Eyes that achieved VMT release and did not undergo surgery attained significant improvement in best-corrected visual acuity (P = 0.015). Complications included subfoveal lucency (33%), ellipsoid zone disruption (33%), and FTMH base enlargement (75%). Only FTMH base enlargement resulted in worse visual outcomes (P = 0.024). Subgroup analysis of 14 eyes with ideal characteristics (all positive predictors listed above) yielded a 93% VMT release rate. Proper case selection may facilitate successful pharmacologic vitreolysis with ocriplasmin, improve visual outcomes, and minimize potential complications.

LONGITUDINAL MICROPERIMETRY EVALUATION AFTER INTRAVITREAL OCRIPLASMIN INJECTION FOR VITREOMACULAR TRACTION.

To determine whether improvements in microperimetry testing are associated with anatomic resolution after ocriplasmin treatment in patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction and relatively preserved baseline best-corrected visual acuity (BCVA). Patients with vitreomacular traction received a single 125-μg intravitreal ocriplasmin injection and were followed longitudinally for 6 months with optical coherence tomography, BCVA testing, and microperimetry. Visual function changes were compared between eyes with and without VMA resolution on optical coherence tomography. Eleven of 16 eyes (68.8%) achieved VMA resolution after treatment. Mean baseline BCVA was relatively good (79 ± 3 Early Treatment Diabetic Retinopathy Study letters; 20/52); no patients had a ≥2-line improvement in BCVA over the 6-month follow-up period. In the group with VMA resolution, mean retinal sensitivity significantly increased in the central 4° (15.2 ± 1.9 dB vs. 18.9 ± 0.7 dB, P < 0.001) when comparing baseline and final follow-up microperimetry testing. No change in mean retinal sensitivity was found in the group without VMA resolution. Microperimetry demonstrates a significant gain in retinal sensitivity, particularly in the central 4° area, in eyes with anatomic resolution after treatment of vitreomacular traction with intravitreal ocriplasmin injection, even when no significant gain in BCVA is seen.

Intravitreal gas for symptomatic vitreomacular adhesion: a synthesis of the literature.

Symptomatic vitreomacular adhesion (sVMA) is defined as visual loss secondary to foveal damage from vitreomacular traction (VMT) and includes isolated VMT, impending macular hole (MH), and full-thickness MH with persisting vitreous attachment. Management options include pars plana vitrectomy (PPV), intravitreal ocriplasmin, intravitreal gas injection or observation. This synthesis of the literature aimed to assess the safety and efficacy of intravitreal gas for sVMA. Articles describing patients with VMT or MH treated with intravitreal expansile gas were selected by systematic literature review using MEDLINE, EMBASE, and the Cochrane Database of Controlled Trials (CENTRAL) up to September 2016. The main outcomes at 1month and final review were logarithm of the minimum angle of resolution (logMAR) visual acuity (VA), anatomical success (absence of both VMT and MH, without PPV) and adverse events (AEs). The intended comparator was observation. Nine of 106 identified articles were eligible, and none were randomized controlled trials. The mean VA of 91 eyes improved from 0.55 (Snellen equivalent 6/21) to 0.48 (6/18) logMAR at 1month and to 0.35 (6/13) logMAR at final review. The mean VA at final review, prior to a vitrectomy, was 0.42 (6/16). Anatomic success was 48% at 1month and 57% at final review. The reported AEs comprised retinal detachment in two highly myopic eyes. Intravitreal gas injection can relieve sVMA. Larger controlled studies are needed to determine safety and efficacy relative to observation, ocriplasmin, or vitrectomy.

Intravitreal ocriplasmin: A breakthrough in the treatment of vitreomacular traction?

Vitreoretinal interface pathologies, such as vitreomacular traction syndrome, epiretinal membranes and macular holes are sight-threatening conditions and one of the important causes of vision defects and vision loss. To this date, vigilance with observation of how the vitreomacular traction resolves, or vitreoretinal surgery in more severe cases, were the only treatment options. Recent rapid progress in ophthalmology, especially in diagnostic and visualization techniques, provided better insight into the mechanisms taking place on the vitreoretinal surface, which enabled a more accurate selection of treatment options. Development of ophthalmic pharmacological procedures, such as treatment of vitreomacular traction syndrome with ocriplasmin, constitutes an innovative breakthrough in ophthalmology. The enzyme is a genetically engineered form of human plasmin, a component of blood coagulation cascade that has been envisioned for human therapy since 1950s. It has never been used for vitreolysis in ophthalmology before. The aim of this review is to analyze and compare therapeutic options for symptomatic vitreomacular adhesion and vitreoretinal traction, with particular emphasis on microplasmin. We reviewed the results of recent studies comparing ocriplasmin to other widespread treatment options, such as pars plana vitrectomy.

Macula Society Collaborative Retrospective Study of Ocriplasmin for Symptomatic Vitreomacular Adhesion

To assess anatomic and visual outcomes of ocriplasmin use for symptomatic vitreomacular adhesion (VMA). Retrospective chart review. Macula Society members were surveyed online to collect data on ocriplasmin for symptomatic VMA. Clinical and optical coherence tomography data were collected using standardized data entry forms. There were 208 patients (208 eyes) with symptomatic VMA followed at least 3 weeks after receiving ocriplasmin. At baseline, VMA was focal (<1500 μm) in 179 eyes (86%), broad in 9 eyes (4%), and not reported in 20 eyes (10%). A full-thickness macular hole (MH) was present in 75 eyes (36%); size was <400 μm in 62 eyes (82%). Baseline mean visual acuity was approximately 20/63. Of the 204 eyes with ≥12 weeks follow-up, pars plana vitrectomy (PPVx) was performed in 12 (6%) by 4 weeks, 31 (15%) by 12 weeks, and 64 (31%) by the last visit. VMA had resolved by 12 weeks with ocriplasmin alone in 83 of 191 eyes (43%) by week 12 and in 148 of 200 eyes (74%) by the last visit, including eyes undergoing PPVx. Among eyes with a baseline MH, closure was achieved with ocriplasmin alone in 10 of 65 (15%) by 1 week, 26 of 74 (35%) by 4 weeks, and 30 of 75 (40%) at the last visit. Mean change in visual acuity at the last visit compared with baseline was-0.06±0.40 logarithm of the minimum angle of resolution (logMAR) (modest vision improvement) (P= 0.03). At the last visit, visual acuity improved by ≥2 lines in 69 eyes (35%) and by ≥3 lines in 54 eyes (27%). Visual acuity decreased ≥2 lines in 35 eyes (18%) and by 3 lines in 27 eyes (14%) at the final visit. Complications included photopsias (15%), dimness of vision (14%), decreased color vision (10%), MH development (5%), macular retinal pigment epithelium atrophy (2.7%), retinal detachment (1.9%), and retinal tear (1.4%). No endophthalmitis cases were reported. Physician-reported outcomes on ocriplasmin use confirmed VMA release in 45% and closure of MH in 40% of eyes without PPVx. Visual acuity decreased in approximately 20% of eyes. Adverse events were not infrequent and suggest caution when considering ocriplasmin use.

The current status and progress of ocriplasmin in treating vitreomacular interface diseases

As a potent collagenase activator, ocriplasmin is a recombinant truncated form of serine protease that retains the protease activity of plasmin. Pre-clinical animal experiments, clinical trials and recent clinical studies all indicated a promising outcome of intravitreal injection of ocriplasmin to treat vitreomacular interface diseases, including vitreomacular adhesion (VMA), vitreomacular traction (VMT) and full-thickness macular hole. Ocriplasmin was approved by the Food and Drug Administration of USA in the management of symptomatic VMA, and by the European Medicines Agency in treating VMT-associated macular hole with less than or equal 400 μm. Further randomized controlled clinical trials are needed for further comprehensive observation and evaluation on its efficiency, safety and other noteworthy issues. Key words: Retinal perforations/drug therapy; Fibrinolysin/therapeutic use; Vitreomacular traction syndrome/drug therapy; Review

The Efficacy and Safety Profile of Ocriplasmin in Vitreomacular Interface Disorders

ABSTRACTVitreomacular adhesion (VMA) describes the adhesion of the posterior hyaloid face to the inner retina in any part of the macula. This can arise after incomplete separation of the posterior vitreous cortex from the macula during vitreous liquefaction. While the VMA may resolve spontaneously, a strong and persistent adhesion can lead to a variety of anatomical changes, including vitreomacular traction (VMT) and macular hole (MH). Both conditions can present with metamorphopsia and decreased vision. In cases of symptomatic VMT and full-thickness macular hole, pars plana vitrectomy has long been the standard of care. However, due to the possible surgical complications and need for postoperative care, many have searched for non-surgical options via pharmacologic vitreolysis. Ocriplasmin (Jetrea, Thrombogenics USA, Alcon/Novartis EU) is a recombinant protease approved in October 2012 for the treatment of symptomatic vitreomacular adhesion (VMA). There have been conflicting views on the safety of Ocriplasmin with changes in the ellipsoid zone seen on OCT and changes seen on ERG indicating photoreceptor damage. This publication reviews the efficacy and safety of ocriplasmin injection for VMA based on previously published data.

Results of the 2-Year Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) Randomized Trial

The Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial was designed to evaluate the long-term efficacy and safety profile of ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA)/vitreomacular traction, including full-thickness macular hole (FTMH). Phase 3b, randomized, sham-controlled, double-masked, multicenter clinical trial. Sample size was 220 subjects (146 ocriplasmin, 74 sham) randomized in a 2:1 ratio to receive intravitreal ocriplasmin 0.125 mg or sham injection. The trial involved 12 visits over 24-months. Inclusion criteria included presence of VMA and best-corrected visual acuity (BCVA) of 20/32 or worse in the study eye. Exclusion criteria included FTMH >400 μm, presence of epiretinal membrane (ERM), and aphakia in the study eye. The primary efficacy end point was the proportion of subjects with pharmacologic VMA resolution at day 28. Secondary efficacy end points were assessed at month 24 and included proportion of subjects with BCVA gain from baseline, nonsurgical FTMH closure, vitrectomy, and Visual Function Questionnaire 25 (VFQ-25) outcomes. The OASIS trial met its primary end point with pharmacologic VMA resolution at day 28 being significantly higher in the ocriplasmin group (41.7%) compared with the sham group (6.2%). The treatment effect was maintained until study end. In the ocriplasmin group, pharmacologic VMA resolution at day 28 was higher in subgroups with the following baseline characteristics compared with the complementary subgroups without them: presence of focal VMA, presence of FTMH, absence of ERM, and phakic lens status. In the ocriplasmin group, 50.5% of subjects had a ≥2-line improvement in BCVA from baseline compared with 39.1% of subjects in the sham group. The nonsurgical FTMH closure rate was 30.0% for the ocriplasmin group compared with 15.4% for the sham group. All other secondary end points also favored ocriplasmin over sham. Regarding safety, most adverse events were mild to moderate, had a short onset time, and were transient, with no new safety signals identified. The OASIS trial demonstrates the long-term efficacy and safety of ocriplasmin, providing improved resolution of symptomatic VMA compared with previous phase 3 trials with no additional safety signals identified.

Baseline Predictors of Vitreomacular Adhesion/Traction Resolution Following an Intravitreal Injection of Ocriplasmin.

To determine factors predicting response to ocriplasmin (Jetrea; ThromboGenics, Iselin, NJ) response in patients with symptomatic vitreomacular adhesion (VMA). Combined analysis of two multicenter, prospective, randomized, double-masked trials of intravitreal ocriplasmin 125 µg injection versus placebo. Patients had vitreomacular traction with or without a full-thickness macular hole (FTMH). Multivariate logistic regression was used to determine factors influencing treatment response (complete VMA release [day 28] and non-surgical FTMH closure [month 6]). Younger age, presence of FTMH (odds ratio [OR] = 2.1; 95% confidence interval [CI], 1.1-3.7), VMA diameter of 1,500 µm or less (OR = 4.9; 95% CI, 2.0-12.4), phakic lens status (OR = 2.8; 95% CI, 1.5-5.2), and absence of epiretinal membrane (OR = 4.1; 95% CI, 2.2-7.9) predicted VMA resolution. FTMHs with apical diameter of 250 µm or less were more likely to close than larger holes (58.3% vs. 24.6%; P = .013). Both FTMH size groups had significantly greater chance of VMA resolution and FTMH closure versus controls. Ocriplasmin is most effective in younger patients with focal VMA and without an epiretinal membrane. [Ophthalmic Surg Lasers Imaging Retina. 2016;47:716-723.].