From the editors of Review of Ophthalmology and Retina Specialist
THE LATEST PUBLISHED RESEARCH
WELCOME to Review of Ophthalmology's Retina Online newsletter. Each month, Medical Editor Philip Rosenfeld, MD, PhD, and our editors provide you with this timely and easily accessible report to keep you up to date on important information affecting the care of patients with vitreoretinal disease.
Non-responders to Ranibizumab Anti-VEGF Treatment Are Actually Short-term Responders
Scientists evaluated the inter-individual variability in duration of the anti-VEGF drug ranibizumab’s treatment effects in neovascular age-related macular degeneration, as part of a prospective, observational study.
Wet AMD patients were treated with ranibizumab and followed weekly for four weeks, with spectral-domain optical coherence tomography assessing the time to maximal reduction of central retinal thickness, as well as the presence of intra- and subretinal fluid.
Forty-eight eyes of 48 individuals (74.79 ±8.25 years old, 60 percent female, 52 percent treatment naïve, 35 percent pseudophakic) were assessed. Here were some of the findings:
• Two-thirds reached maximal CRT reduction earlier than the standard four-week interval: 6.25 percent at one-week post-injection, 22.92 percent at two weeks post-injection and 35.42 percent at three weeks post-injection.
• Only 35.42 percent of individuals had maximal CRT reduction at four weeks.
• Twenty-one percent of treatment-naïve, and 44 percent of non-naïve individuals had a week-four CRT that was >35 µm thicker than the CRT at the earlier CRT nadir time point.
• The time to maximal CRT reduction wasn’t related to axial length, age, lens status or prior history of injections.
Scientists suggested that optimal dosing interval for maximal CRT reduction may be less than four weeks for a significant proportion of patients. They added that most individuals will be classified as complete responders if intervals shorter than four weeks are used to assess anti-VEGF treatment response. Finally, they reported, disease load rather than eye size appeared to be the driver of treatment effect and dosing interval, which needed to be optimized in the cohort of short-term responders.
SOURCE: Bontzos G, Bagheri S, Ioanidi L, et al. Non-responders to ranibizumab anti-VEGF treatment are actually short-term responders: A prospective SD-OCT study. Ophthalmology Retina 2019; Nov 11. [Epub ahead of print].
Ranibizumab for Treatment-naive nAMD
Researchers evaluated the effectiveness, safety and treatment patterns of ranibizumab 0.5 mg in treatment-naive patients with neovascular age-related macular degeneration enrolled in the Novartis-sponsored LUMINOUS study, billed as a “global real-world study.”
The five-year, prospective, multicenter, observational study recruited 30,138 adult patients (treatment-naïve, or previously treated with ranibizumab or other ocular treatments) who were treated according to the local ranibizumab label.
A total of 6,241 treatment-naive neovascular age-related macular degeneration patients were included. At baseline, mean age was 75 ±10.2 years, 54.9 percent were females and 66.5 percent were Caucasian. Here are some of the findings:
• Baseline visual acuity was 51.9 letters (Snellen: 20/92). The mean visual acuity gain at one year was 3.1 ±16.51 letters (n=3,379) with a mean of 5 ±2.7 injections and 8.8 ±3.3 monitoring visits.
• The mean visual gains presented by injection frequencies were:
o <3 injections (n=537), 1.6 ±14.93 letters;
o three to six injections (n=1,924), 3.3 ±16.57 letters; and
o >6 injections (n=918), 3.7 ±17.21 letters.
• Stratified by baseline visual acuity, the mean visual acuity change was:
o baseline visual acuity <23 (n=382), 12.6 ±20.63 letters;
o baseline visual acuity 23 to <39 (n=559), 6.7 ±17.88 letters;
o baseline visual acuity 39 to <60 (n=929), 3.6 ±16.41 letters;
o baseline visual acuity 60 to <74 (n=994), 0.3 ±13.83 letters; and
o baseline visual acuity ≥74 (n=515), -3 ±11.82 letters.
• Incidence of adverse events was: ocular, 8.2 percent; nonocular, 12.8 percent.
• Incidence of serious adverse events was: ocular, 0.9 percent; nonocular, 7.4 percent.
Researchers wrote that the results demonstrated the effectiveness and safety of ranibizumab in treatment-naive nAMD patients.
Source: Holz FG, Figueroa MS, Bandello F, et al. Ranibizumab treatment in treatment-naive neovascular age-related macular degeneration: Results from LUMINOUS, a global real-world study. Retina 2019; Nov 19. [Epub ahead of print].
Exudative AMD Treated with Intravitreal Anti-VEGF Injections: Ten-year Follow-up
Researchers identified the visual acuity outcomes of subjects with age-related macular degeneration treated with intravitreal anti-vascular endothelial growth factor injections over a 10-year period.
Patients receiving ranibizumab 0.5 mg/0.05 mL (Lucentis; Genentech, South San Francisco), bevacizumab 1.25 mg/0.05 mL (Genentech), and aflibercept 2 mg/0.05 mL (Eylea; Regeneron, Tarrytown, New York) were included.
The retrospective, cohort study included eyes with exudative AMD that received ≥2 intravitreal anti-VEGF injections and had at least 10 years of follow-up after the initiation of treatment. Snellen visual acuity was recorded at baseline and then annually until the last year of follow-up. Optical coherence tomography data were collected at the time of treatment initiation and at the last exam visit. Researchers performed a subanalysis on individuals who continued to receive anti-VEGF therapy using a modified treat-and-extend protocol vs. those who discontinued treatment for longer than one year.
A total of 130 eyes of 115 individuals met the inclusion criteria. The mean follow-up after treatment initiation was 11.1 ±0.7 years. Eyes received an average of 45.1 ±32.3 intravitreal injections in total, and a mean of five to seven injections per year. Here were some of the findings:
• The baseline mean logMAR visual acuity was 0.61 ±0.5 (Snellen acuity 20/81), and the final mean logMAR visual acuity was 0.88 ±0.7 (20/152, p≤0.0001).
• A total of 40 eyes received at least one injection every year.
• Eyes receiving at least one injection per year didn’t have a significant change in visual acuity between baseline and final exams—0.47 ±0.4 (20/59 vs. 0.58 ±0.5 [20/76, p=0.28]), whereas eyes that didn’t receive at least one injection per year saw a significant decline in visual acuity—0.67 ±0.5 (20/94 vs. 1.01 ±0.7 [20/205, p<0.0001]).
Researchers determined that eyes with exudative AMD that received intravitreal injections every year had stable visual acuity over a 10-year period. They added that continuous intravitreal anti-VEGF therapy may stabilize visual acuity for 10 years and potentially longer.
Source: Starr MR, Kung FF, Mejia CA, et al. Ten-year follow-up of patients with exudative age-related macular degeneration treated with intravitreal anti-vascular endothelial growth factor injections. Retina 2019; Nov 13. [Epub ahead of print].
Structural OCT Signs of Subclinical Nonexudative Macular NV in Eyes with Large Drusen
Researchers further defined structural optical coherence tomography features making up the "double-layer sign," which is suggestive of subclinical, nonexudative macular neovascularization (NE-MNV) in asymptomatic eyes with age-related macular degeneration.
In the cross-sectional, observational study, participants included individuals with large drusen (>125 μm) secondary to AMD in at least one eye.
Participants in a discovery cohort with known NE-MNV identified on OCT angiography (SS-OCTA) and the double-layer sign on structural spectral-domain OCT imaging were used to identify characteristic features of this sign. The features were then assessed by masked graders in an evaluation cohort of AMD eyes with large drusen to determine the predictive values for NE-MNV. Main outcome measures included a description of OCT features associated with an increased risk of NE-MNV, and their diagnostic and predictive performance. Here were some of the findings:
• The discovery cohort of four eyes revealed that, in retinal pigment epithelium elevations with a greatest transverse linear dimension ≥1,000 μm, an irregular RPE layer, height of predominantly <100 μm, and a non-homogenous internal reflectivity were characteristic features of the double-layer sign when NE-MNV was present. Researchers termed these collective features “SIRE”: Shallow, Irregular RPE Elevation.
• Features on OCT images from 233 eyes in the evaluation cohort that were significantly associated with NE-MNV when RPE elevation was >1,000 um in length were: height of the RPE elevation; an overall flat or variable morphology; RPE layer irregularity; and a non-homogeneous reflectivity (all p≥0.032).
• A total of 24 eyes (10.3 percent) were identified with a SIRE.
• On SS-OCTA imaging, six of the 233 eyes were found to have definite NE-MNVs, and all graded positively for SIRE (100 percent sensitivity).
• The absence of SIRE was identified in 209 of 227 eyes without NE-MNV (specificity=92.1 percent).
• The positive predictive value for SIRE was 25 percent, and the negative predictive value was 100 percent.
Researchers found that OCT images that displayed the SIRE sign were at higher risk of having a subclinical NE-MNV. They determined that SIRE could be used as a screening tool on routine structural OCT imaging and that more frequent follow-up and diligent home monitoring were recommended for those with SIRE features.
SOURCE: Narita C, Wu Z, Rosenfeld PJ, et al. Structural OCT signs suggestive of subclinical nonexudative macular neovascularization in eyes with large drusen. Ophthalmology 2019; Nov. 15. [Epub ahead of print].
Automated vs. Manually Modified OCTA En Face Slabs for Detection of CNV
Investigators evaluated sensitivity and specificity for the detection of choroidal neovascularization using automatically generated vs. manually modified swept-source optical coherence tomography angiography en face images, as part of a prospective cohort study.
Included were consecutive patients with various chorioretinal diseases and subretinal hyperreflective material (SHRM) and/or pigment epithelial detachments (PEDs) on OCT possibly corresponding to CNV in at least one eye.
Fluorescein angiography and SS-OCTA imaging (Plex Elite 9000) were performed on the same day. OCTA en face images were generated using the “retina,” “avascular,” “choriocapillaris” and “outer retina to choriocapillaris (ORCC)” slabs automatically provided by the software. In addition, a custom slab was created by manual modification of the automatically provided boundary “RPE fit” positioned at the level of Bruch’s membrane as well as anterior to any SHRM and/or PED to ensure that a possible CNV was captured in its entirety. Two graders independently evaluated OCTA en face images for the presence of CNV masked to all other images of the patient.
Main outcome measures included sensitivity and specificity for detection of CNV using FA as the reference. A total of 102 eyes of 63 individuals were included. Here were some of the findings:
• In 40 percent of the cases (41 out of 102), a CNV was detected on FA.
• Automatically-provided OCTA en face slabs revealed the highest sensitivity for the ORCC slab (46.3 percent), followed by the retina slab (22 percent), the avascular slab (17.1 percent) and the choriocapillaris slab (14.6 percent).
• Specificity ranged between 93.4 percent for ORCC, and 100 percent for the retina and avascular slab.
• Sensitivity could be increased to 78.1 percent using the custom slab with a specificity of 88.5 percent.
• Concordance between FA and OCTA en face slabs was moderate for the ORCC slab (κ=0.43; range: 0.41 to 0.60) and substantial for the custom slab (κ=0.67; range: 0.61 to 0.80).
Investigators determined that segmentation artifacts and incomplete coverage of CNV on SS-OCTA en face images may impede identification of CNV. They added that manual modification of the position of automatically generated segmentation lines anterior and posterior to any suspected CNV (SHRM and/or PED) increased the sensitivity of CNV detection compared with automatically generated slabs.
SOURCE: Siggel R, Spital C, Lentzsch A, et al. Comparison of automated versus manually modified OCT-angiography en face slabs for detection of choroidal neovascularization. Ophthalmology Retina 2019; Nov 29. [Epub ahead of print].
Outcomes in DME Patients Requiring Cataract Surgery in VISTA & VIVID
Researchers evaluated the impact of cataract surgery on visual and anatomic outcomes in patients with diabetic macular edema treated with intravitreal aflibercept injection or laser (used as a control) who didn’t require rescue therapy, as part of a post hoc analysis of two Phase III trials: VISTA and VIVID. Participants included 54 (laser, n=11; IAI, n=43) patients who underwent cataract surgery during the study period.
In VISTA and VIVID, patients received IAI 2 mg for q4 weeks, IAI 2 mg for q8 weeks following five monthly doses or laser control through week 100. Starting at week 24, if rescue treatment criteria were met, IAI patients received laser, and laser patients received IAI 2q8 (following five monthly doses). Patients who received rescue treatment before cataract surgery were excluded.
Main outcome measures were best-corrected visual acuity and central retinal thickness in the laser and pooled IAI groups before and after cataract surgery. Here were some of the findings:
• The cumulative incidence of cataract surgery didn’t depend on treatment group assignment (rate ratio [CI]=1.517 [0.782, 2.944]; p=0.2174).
• At the last study visit before surgery: in the laser control group, BCVA was 62.2 and CRT was 342 μm; in the IAI group, BCVA was 56.9 letters and CRT was 301 μm.
• At the first visit post-cataract surgery, BCVA was significantly improved
in the laser control group to 73.5 letters (p=0.010 compared with last visit before surgery) and in the IAI group to 67.2 letters (p<0.001 compared with last visit before surgery).
• The corresponding change in CRT was a modest increase in the laser control group to 364 μm (p>0.05 compared with last visit before surgery) and in the IAI group to 359 μm (p=0.013 compared with the last visit before surgery).
Researchers found that the incidence of cataract surgery was similar in both treatment groups. They wrote that, despite a modest worsening in CRT after cataract surgery, BCVA was improved in both treatment groups.
Source: Moshfeghi AA, Thompson D, Berliner AJ, MD, et al. Outcomes in patients with diabetic macular edema requiring cataract surgery in VISTA and VIVID studies. Ophthalmology 2019; Nov. 4. [Epub ahead of print].
Ultra-widefield Protocol Enhances Automated DR Severity Classification Via OCTA
Researchers assessed the diagnostic utility of retinal nonperfusion to classify eyes based on diabetic retinopathy severity on optical coherence tomography angiography. They aimed to determine if OCTA protocols with a wider field of view enhanced the diagnostic utility of retinal nonperfusion in the classification of DR severity, in a retrospective, cross-sectional study.
Subjects included diabetic patients undergoing ultra-widefield OCTA imaging at one academic retina practice.
Ultra-widefield OCTA images with 100-degree FOV were obtained from 60 eyes. Eyes were grouped as diabetes without retinopathy, nonproliferative diabetic retinopathy or proliferative diabetic retinopathy. The ratio of nonperfusion (RNP) was expressed as the percent area of capillary nonperfusion within the FOV. RNP was obtained in the FOV 100 image and concentric sectors encompassing 10, 10 to 30, 30 to 50, and 50 to 100 degrees.
Main outcome measures included mean RNP among DR groups, mean RNP measured among FOV sectors and the area under the ROC curve when utilizing RNP as a cutoff value to distinguish between DR groups. Here were some of the findings:
• The mean RNP from the FOV 50 to 100 region was different among all groups: DWR: 14.6 ±5.1 percent; NPDR: 27.5 ±7.5 percent; PDR: 41.5 ±19.1 percent (p<0.01).
• Within each DR group, FOV 50 to 100 measured higher RNP than all other sectors (p<0.01).
• FOV 50 to 100 gave the highest optimal sensitivity and specificity to distinguish NPDR from DWR with a cutoff value of 21.2 percent (89.5 percent and 88.2 percent, respectively; AUC=0.944) and PDR from NPDR with a cut-off value of 31.6 percent (79.2 percent and 78.9 percent, respectively; AUC=0.752).
Researchers found that RNP was on average higher in more severe DR. They wrote that most peripheral sectors of the widefield OCTA (FOV 50-100) showed, on average, higher RNP and had more diagnostic utility in determining DR severity compared with more central sectors.
Source: Wang F, Saraf SS, Zhang Q, et al. Ultra-widefield protocol enhances automated classification of diabetic retinopathy severity with optical coherence tomography angiography. Ophthalmology Retina 2019; Nov 8. [Epub ahead of print].
Using SS-OCT to Assess Changes Following Panretinal Photocoagulation
Scientists assessed the effect of panretinal photocoagulation on choroidal vascular parameters in eyes with advanced diabetic retinopathy. Forty patients (65 eyes) with severe nonproliferative DR or proliferative DR who underwent PRP were included. They evaluated changes in choroidal vascular parameters at three, six and 12 months after PRP by using swept-source optical coherence tomography, and compared OCT angiography with baseline values.
Here were some of the findings:
• The choroidal vascularity index significantly decreased from 66.27 ±1.55 percent at baseline to 65.85 ±1.61 percent at three months, 65.77 ±1.29 percent at six months and 65.74 ±1.60 percent at 12 months after PRP.
• The ratio of luminal to stromal area (L/S ratio) also significantly decreased from 1.98 ±0.15 at baseline to 1.94 ±0.14 at three months, 1.95 ±0.13 at six months and 1.93 ±0.14 at 12 months after PRP.
• The subfoveal choroidal thickness similarly showed a significant decrease from 319.50 ±56.64 μm at baseline to 299.07 ±51.14 μm at three months, 294.70 ±58.96 μm at six months and 280.93 ±53.57 μm at 12 months after PRP.
• The choriocapillaris vessel density in both the fovea and parafovea showed no significant differences following PRP.
Scientists concluded that eyes with advanced DR showed a significant reduction in CVI, L/S ratio and SFCT over 12 months after PRP treatment.
SOURCE: Kim JT, Park N. Changes in choroidal vascular parameters following pan-retinal photocoagulation using swept-source optical coherence tomography. Graefes Arch Clin Exp Ophthalmol 2019; Nov 3. [Epub ahead of print].
Using OCTA to Assess the Relationship of Geographic Altitude with FAZ Metrics & Vascular Density Values
Investigators analyzed variations in vascular density and foveal avascular zone metrics in relation to geographical altitude, as part of a cross-sectional study on healthy volunteers from six Latin-American cities.
A total of 185 volunteers were recruited over a three-month period. The RTVue-XR Avanti system (Optovue) was used along with split-spectrum, amplitude-decorrelation angiography (SSADA) software 7.1 to obtain optical coherence tomography angiography images from 3-mm2 and 6-mm2 Angioscans centered on the fovea for the superficial capillary plexus (SCP) and deep capillary plexus (DCP). FAZ measurements were performed in a full retina slab based on the full retina vasculature by using OCT angiograms. Analyses of variance were performed for all variables, with p-values <0.05 indicating statistical significance.
Main outcome measures included retinal SCP and DCP vascular density values in 3 mm2 and 6 mm2 angioscans; and FAZ area, perimeter and parafoveal density at 300 μm.
A total of 375 eyes of 185 subjects (71 males and 114 females; mean age, 39.09 ±15.06 years; age range, 20 to 80 years) were assessed. Here were some of the findings:
• With 3 mm2 scans, the mean VD was 46.94 percent (±3.11 percent) in the SCP and 52.48 percent (±3.14 percent) in the DCP, while the corresponding values with 6-mm2 scans were 50.62 percent (±3.13 percent) in the SCP and 52.87 percent (±5.5 percent) in the DCP.
• At 300 μm, mean FAZ area was 0.31 mm2 (±0.11 mm2); perimeter was 2.18 mm (±0.43 mm); and parafoveal density was 51.44 percent (±3.64 percent).
• Mean SCP VD values in 3-mm2 scans were significantly higher in La Paz and and lower in Lima compared with those in the other cities (p=0.001).
• No differences were noted for SCP in the 6-mm2 scans.
• FAZ metrics and VD values both in 3-mm2 and 6-mm2 scans of the DCP showed no significant differences.
Investigators reported that VD showed a direct relationship with geographical altitude in SCP 3-mm2 scans in the healthy Hispanic volunteers, indicating that geographical altitude should be accounted for when performing retinal OCTA evaluation of VD values.
Source: Acosta C, Gloria JM, Lavaque A, et al. Relationship of geographic altitude with foveal avascular zone metrics and vascular density values assessed by optical coherence tomography angiography. Ophthalmology Retina 2019; Nov 7. [Epub ahead of print].
BIOGEN COMPLETES ENROLLMENT FOR PHASE III TRIAL FOR INHERITED RETINAL DISORDER, EXPANDS BIOSIMILARS PORTFOLIO
Biogen announced enrollment of the last patient in its global Phase III STAR clinical study, evaluating the investigational gene therapy timrepigene emparvovec (BIIB111/AAV2-REP1) for the treatment of choroideremia. STAR is a randomized, masked, prospective, parallel-controlled group study that enrolled 170 adult males with CHM to evaluate the safety and efficacy of a single subretinal injection of timrepigene emparvovec. The primary endpoint is the proportion of patients with an improvement of at least 15 letters from baseline in best-corrected visual acuity at 12 months post treatment as measured by the Early Treatment Diabetic Retinopathy Study visual acuity protocol. Read more.
In addition, the company announced a proposed transaction with Samsung Bioepis to secure exclusive rights to commercialize two new ophthalmology biosimilars, SB11 referencing Lucentis and SB15 referencing Eylea, in major markets worldwide, including the United States. In addition, Biogen will acquire exclusive commercialization rights for its anti-TNF portfolio. Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator’s approved biological product, with the purported advantage that they offer cost savings and promote “sustainable access to therapies,” Biogen says. Read more.
SOURCE: Biogen, November 2019
PROQR RECEIVES ORPHAN DRUG DESIGNATION FOR QR-1123
ProQR Therapeutics received Orphan Drug designation from the FDA for QR-1123, a first-in-class investigational antisense oligonucleotide designed to address the underlying cause of vision loss associated with autosomal dominant retinitis pigmentosa due to the P23H mutation in the rhodopsin (RHO) gene. (ODD provides a special status for investigational drugs being developed for rare diseases.) The therapy aims to inhibit the formation of the mutated toxic version of the rhodopsin protein by specifically binding the mutated RHO mRNA. Aurora, the PQ-1123-001 trial, is a first-in-human study that will initially include up to 35 adults with adRP due to the P23H mutation in the RHO gene. Read more.
SOURCE: ProQR Therapeutics, November 2019
LIMELIGHT BIO EMERGES WITH $75 MILLION TO DEVELOP GENE THERAPIES
Limelight Bio, a privately held biopharmaceutical company developing novel gene therapies in ophthalmology and other medical specialties, raised $75 million in financing from Apple Tree Partners. Founded in 2017, Limelight Bio says it has developed drug candidates designed to overcome key limitations of gene therapy and gene editing targeted to severe retinal diseases for which no current therapies exist. Read more.
Source: Limelight Bio, December 2019
FDA Approves Special Protocol Assessments for Outlook Therapeutics’ ONS-5010 Trials
Outlook Therapeutics received agreement from the FDA for three Special Protocol Assessments for three additional registration clinical trials for its ongoing Phase III program for ONS-5010, an investigational ophthalmic formulation of bevacizumab. The agreements reached with the FDA cover the protocols for NORSE 4, a registration clinical trial to treat BRVO; and NORSE 5 and NORSE 6, two registration clinical trials to treat DME. Read more.
SOURCE: Outlook Therapeutics, December 2019
Opthea to Raise $33 Million for Retinal Eye Disease Development
Opthea plans to raise $33 million for the late-stage clinical development of OPT-302 for retinal eye diseases such as wet AMD. The company says it will also use the proceeds for the manufacture of clinical-grade OPT-302 for Phase III clinical development and the start of two concurrent Phase III registrational trials in wet-AMD patients.
Source: Opthea, December 2019
QUANTEL MEDICAL’S VITRA 2 GETS FDA NOD
Quantel Medical received FDA approval for the Vitra 2 photocoagulator, which incorporates key elements of the Vitra photocoagulator and includes new features and functionalities. An optimized laser cavity offers an increased max power level, the company says, as well as compatibility with SingleSpot and MultiSpot technologies. Quantel says the device’s “clinically oriented” software interface is designed to simplify treatment procedures and doctor workflow, and that the Vitra 2 is compatible with various delivery systems. Read more.
SOURCE: Quantel Medical, December 2019
BVI Expands Vitreoretinal Surgery Presence
BVI acquired Arcadophtha (Arcad), a French ophthalmic company specializing in silicone oils, gases and perfluorocarbons used in vitreoretinal surgery. The company says that the growth of the Arcad products will be accelerated through BVI's commercial infrastructure established with the Vitreq line of vitreoretinal surgical products. The transaction closes during the fourth quarter of 2019. Read more
SOURCE: BVI, December 2019
RESEARCHERS CONFIRM NEW FINDINGS ON PHOTORECEPTORS
UC Berkeley researchers found that mice can detect light before full retina development, according to a recently published study in Current Biology
. The team examined how mouse pups are able to detect light without having fully developed retinas. After conducting a series of experiments, the group found that the pathway was mediated by cells called “intrinsically photosensitive retinal ganglion cells,” or ipRGCs, which were connected in a way that amplified the ability to detect light. Read more
SOURCE: University of California, Berkeley, November 2019
OCULAR THERAPEUTIX ANNOUNCES OPERATIONAL RESTRUCTURING
Ocular Therapeutix announced an operational restructuring plan which, upon completion, is expected to result in an estimated $11 million in annualized savings through personnel reductions and approximately $14 million in one-time program deferrals. Ocular Therapeutix says that the restructuring represents a strategic realignment and commitment to allocate capital and resources to maximize the commercial opportunity of Dextenza and focus resources on progressing the company’s Dextenza Phase III trial in allergic conjunctivitis, Phase I trials of OTX-TIC for the treatment of glaucoma and ocular hypertension, and OTX-TKI for the treatment of wet age-related macular degeneration. Read more
Source: Ocular Therapeutix, November 2019
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