Review of Ophthalmology's Retina Online


Volume 14, Number 7
July 2018

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.

Genentech Unveils Positive Phase II Results for Sustained-delivery of Ranibizumab
Positive topline results from Genentech’s Phase II LADDER study evaluating the efficacy and safety of its investigational port delivery system with ranibizumab in people with wet age-related macular degeneration...

Acucela Data On Emixustat Hydrochloride
Acucela announced new data on the effect of emixustat hydrochloride on retinal thickness in diabetic retinopathy...

And More...

Lessons From Recent Phase III Trial Failures

In a recent editorial, authors wrote that, over the past two years, the field has witnessed the failure of three Phase III clinical trials designed to test new treatments for age-related macular degeneration. This came as a surprise to many retinal specialists, who have enjoyed a large number of successful Phase III clinical trials over the past 12 years, the authors added. Although Phase III trial failures are unavoidable for a myriad of reasons in the high-risk drug approval process, the authors suggested that certain Phase III clinical trial designs should be avoided to optimize the likelihood of success.

Upon closer inspection of the three failed Phase III trials, the authors found that the trials didn’t adhere to certain rules of drug development that provide the best chance for success—one of which is to design a Phase III clinical trial based on an unambiguously successful Phase II clinical trial design. When Phase II trial results are equivocal or negative, authors wrote, there is a temptation to perform retrospective subgroup analyses of the Phase II trial and then design the Phase III trial based on a positive retrospective subgroup. The authors wrote that this practice should be avoided.

When designing a Phase III clinical trial, if a Phase II clinical trial is unambiguously positive, then the same core clinical trial design should be used in the subsequent Phase III clinical trial, authors recommended. And though the authors support subgroup analyses to help design future studies and identify populations that may benefit the most from a particular therapy, they stressed that the results from subgroup analyses must be validated by performing another Phase II prospective, randomized clinical trial before moving into a larger Phase III registration trial. They added that this extra step takes more time and more money, but helps avoid wasting more money and time when the Phase III study fails, and avoids putting patients at unnecessary risk during the trial.

SOURCE: Rosenfeld PJ, Feuer WJ, et al. Lessons from recent Phase 3 trial failures: Don’t design Phase 3 trials based on retrospective subgroup analyses from Phase 2 trials. Ophthalmology 2018; July 3. [Epub ahead of print].


Retinal Volume as OCT Biomarker for Disease Activity in nAMD

Researchers wrote that current algorithms for automated computer interpretation of optical coherence tomography imaging of individuals with neovascular age-related macular degeneration mainly rely on fluid detection. However, correct interpretation of the fluid currently limits diagnostic accuracy, they added. Therefore, researchers performed a detailed analysis of requirements that would have to be met to validate fluid detection approaches. They further investigated if monitoring retinal volume would be a viable alternative to detect disease activity.

The study included retrospective analysis and manual grading of 764 OCT volume scans of 44 individuals with exudative AMD treated with intravitreal anti-VEGF injections as part of a pro re nata treatment regimen for at least 24 months and reported their findings.

• Detection of subretinal fluid or intraretinal fluid alone wasn’t sufficient for disease detection. Researchers suggested that combining these findings with SRF and IRF could detect disease activity with a sensitivity of 98.6 percent and a specificity of 82 percent and that, with further characterization of IRF into exudative and degenerative cysts, specificity could be increased to 100 percent. They added that correct characterization is currently not achieved by published fluid detection approaches.
• Changes in macular retinal volume could reveal disease activity with sensitivity of 88.4 percent and specificity of 89.6 percent. Researchers found that combining this measurement SRF with detection could improve diagnostic accuracy to a specificity of 93.3 percent and sensitivity of 93.9 percent without relying on IRF or IRF characterization.

Researchers determined that fluid detection without further characterization wasn’t sufficient for AMD monitoring. They wrote that either additional distinctions between exudative and degenerative cysts would be necessary for monitoring or other activity markers would have to be taken into account. Researchers concluded that MRV offered the potential to fill this diagnostic gap and might become an important monitoring marker.

SOURCE: von der Burchard C, Treumer F, Ehlken C, et al. Retinal volume change is a reliable OCT biomarker for disease activity in neovascular AMD. Graefes Arch Clin Exp Ophthalmol 2018; June 18. [Epub ahead of print].



Intravitreal Aflibercept for Exudative AMD with Good VA

Researchers reported the two-year outcomes of intravitreal aflibercept for exudative age-related macular degeneration with good visual acuity, and examined the baseline factors associated with good visual outcome.

The multicenter, prospective study evaluated 39 eyes (39 individuals with AMD) enrolled from August 2013 to August 2014, at 12 and 24 months. Only individuals with initial best-corrected VA (BCVA) >0.3 logMAR (20/40 Snellen) were eligible. Three consecutive monthly IVA injections were followed by two monthly injections for 12 months. Thereafter, individuals received injections on a treat-and-extend regimen for up to 24 months. Outcome measures included BCVA and central macular thickness at 12 and 24 months. Researchers evaluated post hoc analysis, BCVA and CMT by AMD types (typical AMD [tAMD], type 1 and type 2 polypoidal choroidal vasculopathy). They evaluated baseline characteristics and BCVA associations with linear regression analysis and Student’s t-test.

The mean age was 69 years, and 26 of 39 eyes were male. tAMD occurred in 18 eyes, type 1 occurred in 12 eyes and type 2 PCV occurred in nine eyes. Baseline mean BCVA was 0.097 logMAR (20/25 Snellen) and showed significant improvement to 0.058 (20/22 Snellen, p=0.03) at 12 months and 0.066 (20/23) at 24 months. CMT improved significantly from 320 ±99 µm to 250 ±93 µm (p=0.002) at 12 months and 240 ±93 µm (p=0.0005) at 24 months. BCVA and CMT weren’t significantly different among the three groups. Only subretinal hemorrhage was significantly associated with improved BCVA. BCVA change from baseline was -0.12 with SRH and -0.011 without SRH (p=0.017) at 12 months.

Researchers wrote that IVA showed good efficacy for exudative AMD with good VA at 24 months and that tAMD and type 1 and 2 PCV showed similar prognoses. They concluded that baseline SRH predicted favorable long-term vision in AMD with good VA.

SOURCE: Sakamoto S, Takahashi H, Inoue Y, et al. Intravitreal aflibercept for exudative age-related macular degeneration with good visual acuity: 2-year results of a prospective study. Clin Ophthalmol 2018;12:1137-47.

Evaluation of Multispectral Imaging in Diagnosing Diabetic Retinopathy

Scientists assessed multispectral imaging as a novel diagnostic approach for diabetic retinopathy in clinical settings.

A total of 50 type 2 diabetic patients (99 eyes) were enrolled in this cross-sectional study. All subjects underwent digital fundus photography, MSI and fundus fluorescein angiography. Scientists calculated total exact agreement, sensitivity, specificity, positive predictive value and negative predictive value of no DR/mild nonproliferative DR and severe NPDR/proliferative DR grading based on DFP and MSI, and compared the findings with fundus fluorescein angiography.

Compared with fundus fluorescein angiography:
• The exact agreement for MSI was 0.835; for DFP it was 0.614.
• The sensitivity for no DR/mild NPDR in MSI and DFP was 100 percent, and for severe NPDR/PDR it was 97.4 percent and 88.3 percent.
• The specificity for no DR/mild NPDR in MSI and DFP was 96.3 percent and 95 percent, and for severe NPDR/PDR it was 100 percent in both.
• The positive predictive value for no DR/mild NPDR in MSI and DFP was 86.4 percent and 82.6 percent, and for severe NPDR/PDR it was 100 percent in both.
• The negative predictive value for no DR/mild NPDR in MSI and DFP was 100 percent, and for severe NPDR/PDR it was 91.7 percent and 71 percent in both.

Scientists found that multispectral imaging displayed excellent agreement with fundus fluorescein angiography in DR grading, suggesting it might serve as a new diagnostic technique for evaluating DR.

SOURCE: Li L, Zhang P, Liu H, et al. Evaluation of multispectral imaging in diagnosing diabetic retinopathy. Retina 2018; Jun 12. [Epub ahead of print].

Quantitative Assessment of Macular Contraction & Vitreoretinal Alterations in Anti-VEGF-treated DME

Scientists evaluated macular contraction after anti-vascular endothelial growth factor injections for diabetic macular edema by documenting the displacement of macular capillary vessels and epiretinal membrane formation.

A total of 130 eyes were included in the retrospective study. The study group consisted of 63 eyes that had intravitreal anti-VEGF injections for DME, and the control group included 67 eyes without central DME. Both groups were balanced in terms of diabetes duration and HbA1c. Scientists measured the distances between the bifurcation of the macular capillary retinal vessels, and evaluated ERM status based on spectral-domain optical coherence tomography findings on initial and final visits.

In the study group, the mean number of injections was 4.7 ±2.6 (range: 3 to 14) and the mean follow-up time was 16.7 ±7.8 months vs. 20.7 ±10.9 months in the control group (p=0.132). The change in distance measurements between the reference points on macular capillary vessels was significant in all lines except line c (p<0.05 for lines a, b, d, e and f) in the study group, while this change was only significant in line e in controls (p=0.007, paired samples test). However, when the change in macular thickness was accounted for as a confounding factor, the change in distances between the reference points from the initial and final visits lost its significance (repeated measures ANCOVA, p>0.05). During follow-up, the number of cases with ERM formation changed from 10 to 12 in the study group although it remained three in the control group.

Scientists found a displacement of macular capillary vessels associated with a change in macular thickness in eyes having anti-VEGF injections for DME. They added that the number of ERM cases didn’t change significantly during the follow-up.

SOURCE: Cetin EN, Demirtaş Ö, Özbakış NC, et al. Quantitative assessment of macular contraction and vitreoretinal interface alterations in diabetic macular edema treated with intravitreal anti-VEGF injections. Graefes Arch Clin Exp Ophthalmol 2018; June 20. [Epub ahead of print].

Fixation Status After Resolution of Macular Edema Associated with BRVO

Researchers say that fixation status of eyes with branch retinal vein occlusion is associated with vision and other clinical parameters.

The researchers looked at 57 consecutive eyes with BRVO after resolution of macular edema. They used microperimetry to determine fixation status. Defect length of the foveal ellipsoid zone band was measured by optical coherence tomography, and retinal perfusion status was assessed by OCT angiography.

In microperimetry, researchers found the mean fixation rate around the gravitational center of all fixation points (defined as the fixation center) to be 79.8 ±18.9 percent, which was significantly associated with defect length of the foveal ellipsoid zone band (p<0.001) and the distance between the foveal and fixation centers (p=0.012). The integrity of the ellipsoid zone band at the fixation center was intact in 55 eyes (96.5 percent). Fixation centers were located within and outside the foveal avascular zone in 33 (57.9 percent) and 24 (42.1 percent) eyes, respectively; in the latter group, all fixation centers were perfused. Downward deviation of fixation points was rare, despite variations in the occluded area; there was a significant difference in distribution of deviation between eyes with superotemporal and inferotemporal BRVO (p<0.001).

In eyes with BRVO, fixation status was strongly associated with visual acuity, morphologic damage, and retinal perfusion status both in the foveal area and at the fixation center after resolution of macular edema. This information regarding fixation status could facilitate vision management in patients with BRVO.

SOURCE: Kogo T, Muraoka Y, Ooto S, et al. Fixation status after resolution of macular edema associated with branch retinal vein occlusion. Retina 2018; July 13. [Epub ahead of print].

IVB & Posterior Sub-tenon’s Injection of Triamcinolone Acetonide in ME Secondary to RVO

Researchers compared the efficacy and safety between posterior sub-Tenon’s injection of triamcinolone acetonide (PSTA) and intravitreal injection of bevacizumab (Avastin) (IVIA) in the treatment of macular edema secondary to retinal vein occlusion.

In the study, the investigators retrospectively studied a total of 45 eyes (23 eyes with intravitreal bevacizumab and 22 eyes with posterior sub-Tenon’s triamcinolone acetonide). Main endpoints included logMAR of best-corrected visual acuity, central macular thickness and intraocular pressure after treatment at six months.

At six months, the mean logMAR vision improved from 0.78 (around 20/125) to 0.56 (slightly better than 20/80) for intravitreal bevacizumab (p=0.001), and from 0.91 (about 20/160) to 0.79 and 0.87 at three and six months (p=0.038 and 0.13), respectively, for sub-Tenon’s triamcinolone acetonide. At six months, the BCVA was significantly better in the bevacizumab group (p=0.02). Both groups’ mean CMT significantly improved, from 478 µm at baseline to 295 µm at six months in the IVIA group (p<0.001) and from 419 µm at baseline to 350 µm in the PSTA group (p=0.012); however, this wasn’t different between the groups at six months (p=0.065). Recurrence of macular edema wasn’t different between the groups either (p=0.08). Poorer final vision was associated with poorer baseline BCVA and diagnosis of central retinal vein occlusion after adjustment for age and sex (p<0.001 and 0.012, respectively). Significant elevation of IOP was noted at three months in the PSTA group, but declined at six months compared with baseline (p=0.002 and 0.41, respectively).

Intravitreal bevacizumab seemed to achieve better visual acuity compared with posterior sub-Tenon’s injections of triamcinolone acetonide at six months, while CMT was comparable. PSTA still resulted in transient IOP elevation.

SOURCE: Tsai MJ, Hsieh YT, Peng YJ, et al. Comparison between intravitreal bevacizumab and posterior sub-tenon injection of triamcinolone acetonide in macular edema secondary to retinal vein occlusion. Clin Ophthalmol 2018;12:1229-35.

Molecular Diagnostic Test for Retinitis Pigmentosa

In a recent study, researchers noted that retinitis pigmentosa is the most common form of inherited retinal dystrophy caused by different genetic variants and that more than 60 causative genes have been identified to date. They suggested that establishing cost-effective molecular diagnostic tests with high sensitivity and specificity could be beneficial for individuals and clinicians, so they developed a clinical diagnostic test for RP in a Japanese population and evaluated the technology in a prospective, clinical and experimental study.

Researchers established a panel of 39 genes reported to cause RP in Japanese patients. They used next-generation sequence technology to analyze 94 probands with RP and RP-related diseases. After interpreting detected genetic variants, a multidisciplinary team of clinicians, researchers and genetic counselors made a molecular diagnosis based on a review of the genetic variants and clinical phenotype.

NGS analyses identified 14,343 variants from 94 probands, of which 189 variants from 83 probands (88.3 percent of cases) were found to be pathogenic; 64 probands (68.1 percent) had disease-causing variants. After reviewing the 64 cases, the team made molecular diagnoses in 43 probands (45.7 percent). The final molecular diagnostic rate with the system combining supplemental Sanger sequencing was 47.9 percent (45 of 94 cases).

Researchers determined that the RP panel provided a significant advantage in detecting genetic variants with a high molecular diagnostic rate. This type of race-specific, high-throughput genotyping enabled researchers to conduct a cost-effective and clinically useful genetic diagnostic test.

SOURCE: Maeda A, Yoshida A, Kawai K, et al. Development of a molecular diagnostic test for retinitis pigmentosa in the Japanese population. Jpn J Ophthalmol 2018; May 21. [Epub ahead of print].

Risk of POAG Following Vitreoretinal Surgery

Scientists determined the risk of primary open-angle glaucoma following vitreoretinal surgery, as part of a retrospective, population-based cohort study.

All residents of Olmsted County, Minn., undergoing scleral buckle and/or vitrectomy between 2004 and 2015 were included in the operative cohort. Fellow non-operative eyes were included in the comparison cohort. The study cohort consisted of 344 eyes and the comparison cohort consisted of 277 eyes. The main outcome measure was the development of POAG. Secondary glaucomas were excluded. Scientists compared the probability of glaucoma in operative eyes and nonoperative fellow eyes. The observed rate of POAG in operative eyes was also compared to the rate of POAG in the population.

The mean patient age was 64.7 years, and the median follow-up period was 4.9 years. A total of 58 eyes were in the scleral-buckle cohort, 57 eyes were in the scleral-buckle-with-vitrectomy cohort and 229 eyes were in the vitrectomy-only cohort.
• The 10-year cumulative probability of developing glaucoma was significantly greater in the operative group (CI, 3.8 to 14 percent) compared with the nonoperative group (1 percent, CI 0 to 2.4 percent; p=0.02).
• No eyes in the scleral buckle group developed glaucoma.
• The 10-year probability of POAG was 17.5 percent (CI 0 to 34.9 percent) in scleral buckle-with-vitrectomy and 10 percent (CI, 3 to 17 percent) in vitrectomy-alone cohorts.
• Rates of POAG in operative eyes undergoing scleral buckle with vitrectomy and vitrectomy alone were significantly greater than those of POAG for the general population (1 percent, p<0.001).

Scientists determined that the risk of POAG was increased after vitrectomy in this population.

SOURCE: Mansukhani SA, Barkmeier AJ, Bakri SJ, M, et al. The risk of primary open angle glaucoma following vitreoretinal surgery—a population-based study. Am J Ophthalmol 2018; June 22. [Epub ahead of print].

Resolution, Depth of Field and Physician Satisfaction During Digitally Assisted Vitreoretinal Surgery

Investigators evaluated depth of field, lateral resolution and image quality of a heads-up 3D visualization system for vitreoretinal surgery using physician survey and optical measurement outcomes. One of the investigators is employed by TrueVision Systems, which makes heads-up 3D viewing systems.

They compared depth of field and lateral resolution between the standard ocular viewing system and the digital 3D system at ×5, ×13 and ×18 magnification by six retinal surgeons. They also used optical techniques and a survey of surgeon impressions, performed after six weeks of surgical use. Their findings included:

• Physician questionnaire survey scores for depth of field at high magnification were better for the digital 3D system and equivalent for all other categories.
• Measured lateral resolution was, for digital 3D and oculars, respectively: 36.7 mm and 16.6 mm at ×5 magnification (p<0.001); 14.3 mm and 6.4 mm at ×13 magnification (p<0.001); and 9.8 mm and 4.2 mm (p<0.001) at ×18 magnification.
• Measured depth of field was 6.78 mm and 4 mm at ×5 magnification (p=0.027), 0.86 mm and 0.72 mm at ×13 (p=0.311), and 0.40 mm and 0.28 mm at ×18 magnification (p=0.235) for digital 3D and oculars, respectively.

Investigators concluded that lateral resolution of the digital 3D system was half that of the ocular viewing system, and depth of field showed some improvement with the digital system.

SOURCE: Freeman WR, Chen KC, Ho J, et al. Resolution, depth of field and physician satisfaction during digitally assisted vitreoretinal surgery. Retina 2018; June 27. [Epub ahead of print].


Genentech Unveils Positive Phase II Results for Sustained-delivery of Ranibizumab

Positive topline results from Genentech’s Phase II LADDER study evaluating the efficacy and safety of its investigational port delivery system with ranibizumab in people with wet age-related macular degeneration revealed the majority of PDS patients enrolled in the trial went six months or longer between implant of the device and the first refill. In addition, vision outcomes in the high-dose PDS group were similar to monthly ranibizumab eye injections and were maintained throughout the study period. The small, refillable eye implant, which is slightly longer than a grain of rice, is designed to allow people with wet AMD to go several months without needing to visit their ophthalmologist for treatment. Read more.

Source: Genentech, July 2018

Acucela Data On Emixustat Hydrochloride

Acucela announced new data on the effect of emixustat hydrochloride on retinal thickness in diabetic retinopathy. A randomized, placebo-controlled, Phase II clinical trial exploring the effect of oral emixustat hydrochloride in a proliferative DR population with and without macular edema indicated that the emixustat group experienced a reduction in central subfield thickness when compared with placebo at a statistically significant level (difference in means of 48.1 µm favoring emixustat, p=0.0764; statistical significance pre-specified at p<0.1). Read more.

Source: Acucela, June 2018

Apellis’ APL-2 on the Fast Track

Apellis Pharmaceuticals announced that the U.S. FDA granted Fast Track designation to the company’s APL-2, a novel inhibitor of complement factor C3, as a next-generation monotherapy for the treatment of patients with geographic atrophy. Apellis plans to initiate a Phase III trial for patients with GA later this year which will consist of two identical, prospective, multicenter, randomized, double-masked, sham-injection controlled studies to assess the efficacy and safety of multiple intravitreal injections of APL-2 in patients with GA. Read more.

Source: Apellis Pharmaceuticals, July 2018

Nightstar Receives Advanced Therapy Designation for NSR-REP1 in Choroideremia

Nightstar Therapeutics announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy designation to NSR-REP1, the company’s lead product candidate currently in Phase III development for the treatment of choroideremia. The company says the designation was based on clinical data supporting the maintenance and improvement of visual acuity from completed Phase I/II trials in choroideremia patients treated with NSR-REP1 and disease progression in untreated patients in the ongoing NIGHT natural history observational study. Read more.

Source: Nightstar Therapeutics, June 2018

AiVita Receives $1.7 million CIRM Grant to Treat Vision Loss

AiVita Biomedical announced that the California Institute for Regenerative Medicine awarded the company with $1.7 million in funding to further development of their stem cell-derived three-dimensional retina to treat vision loss. The company's Root Of Sight technology uses three-dimensional retina sheets created from human stem cells, transplanted into the back of the eye, to replace lost retina and improve visual acuity. The forthcoming CIRM-funded study will be conducted in collaboration with the Sue & Bill Gross Stem Cell Research Center at University of California, Irvine, a member of the UCLA-UCI Alpha Stem Cell Clinic. Read more.

Source: AiVita Biomedical, July 2018

Foundation Fighting Blindness Urges Congress to Pass Eye-Bonds Legislation

The Foundation Fighting Blindness expressed strong support of a bipartisan bill introduced late July 18, 2018, in the U.S. House of Representatives that holds promise for saving and restoring the vision of the adults and children in the United States who are blind or have severely impaired vision from a variety of eye diseases and conditions, including inherited retinal diseases and age-related macular degeneration. The Faster Treatments and Cures for Eye Diseases Act, H.R. 6421 would allow for the creation of Eye-Bonds, and would fund translational research and advance treatments and cures for blindness and other causes of severe vision impairment. Eye-Bonds would finance packages of loans that would total $1 billion for new projects over four years in the pilot phase. Read more.

Source: Foundation Fighting Blindness, July 2018

Mobile Retina App Detects Edema and Fluid in OCT Images

Houston-based Retina-AI recently released a smartphone app, Fluid Intelligence, that the company says helps users detect macular edema and subretinal fluid on optical coherence tomography scans with “greater than 90-percent accuracy.” Retina-AI says the app can be useful in catching diseases such as diabetic macular edema, wet age-related macular degeneration and edema after retinal vein occlusions. It accomplishes this by using cloud-based, machine-learning AI algorithms. Read more.

Source: Retina-AI, July 2018

BioTime Awarded NIH Grant

BioTime received a $743,345 grant from the Small Business Innovation Research program of the National Institutes of Health. This award constitutes the second-year funding of a $1.6 million SBIR grant to advance BioTime’s retinal restoration program addressing advanced retinal diseases and injuries. BioTime says that data from the retinal restoration program have shown success in growing complete human three-dimensional retinal tissue derived from the company’s human pluripotent cells and in functional integration for advanced retinal degeneration in proof-of-concept animal models. The technology is being developed to potentially treat or prevent a variety of diseases and injuries leading to blindness. Read more.

Source: BioTime, June 2018


Alcon launched Finesse Sharkskin ILM Forceps at the American Society of Retina Specialists annual meeting in Vancouver, Canada. Alcon calls the forceps a “next-generation tool designed to provide increased surgical precision and enhance retina surgery outcomes.” The forceps have a large grasping platform and a textured tip surface, to help surgeons more easily grasp and peel the internal limiting membrane and minimize trauma to the retina in the process, Alcon says, adding that the forceps are designed to deliver an optimized grasping platform to minimize membrane shredding that can be caused by multiple grasping attempts. The laser-ablated micro-structures on the tip surface, which resemble the textured skin of a shark, increase friction between tissue and forceps to improve grip during ILM peeling, the company says. The conforming forceps also provide a 59 percent larger platform in 27 gauge to decrease the closing angle and increase the length of the grasping edge. The forceps are available in 23, 25+ and 27+ gauge sizes. Read more.

Recently, Alcon also launched the new NGENUITY 3D Visualization System with DATAFUSION at the 2018 American Society of Retina Specialists annual meeting. Alcon says that the high-definition screen of the NGENUITY system provides retinal surgeons 3D visualization of the back of the eye with greater depth and detail during surgery than traditional microscopes and now, with the addition of the DATAFUSION software, the system also offers integration with the CONSTELLATION Vision System, the company's platform for vitreoretinal surgery. The company says that the integration of the systems lets surgeons to track key data parameters in real-time, such as intraocular pressure, flow rates, infusion pressure and laser power, on one screen. Read More.

Source: Alcon, July 2018

MPOD Measurement Earns AMA CPT III Code for Use in Research

EyePromise announced that its macular pigment optical density measurement by heterochromatic flicker photometry earned a category III CPT code from the American Medical Association. The code, which doesn’t receive paid reimbursement, is used for data collection and tracking for products or services involved in planned or ongoing research to help researchers substantiate widespread usage and efficacy, the company says. Read more.

Source: EyePromise, July 2018

Zeiss Introduces Ophthalmic Laser Visulas Green

Zeiss unveiled its next-generation Visulas green photocoagulation laser at the World Ophthalmology Congress in Barcelona. Zeiss says the retinal photocoagulation laser offers more seamless workflow by giving doctors the ability to monitor important treatment settings directly from the eyepiece and a way to change settings while operating a joystick. Integrated data management provides user-specific treatment protocols and a contact lens database for multiple users. Designed as a modular and expandable laser workstation, the laser is available in classic and comfort models, and with a choice of single or dual fiber ports, the company says. Read more.

Source: Zeiss, June 2018

Notal Vision Simplifies Customer Onboarding for ForeseeHome AMD Monitoring Program

Notal Vision launched a new patient onboarding process that it says provides a more streamlined onboarding experience as they begin testing with the company’s ForeseeHome age-related macular degeneration monitoring system. Immediately after receiving a prescription, individuals connect with a qualified health-care professional to walk them through the entire onboarding process. During the initial call, patients will be given important education about AMD and the device, as well as customized information and assistance. In addition, ForeseeHome devices will now be shipped immediately following the initial call so that individuals can begin monitoring their vision right away. Notal Vision says the new program also offers a communication feedback loop that continues to engage patients as they proceed through testing. Read more.

Source: Notal Vision, June 2018

FDA Accepts NDA Filing for B+L’S Loteprednol Etabonate

Bausch + Lomb announced that the FDA accepted the New Drug Application for its sub-micron loteprednol etabonate ophthalmic gel, 0.38%, with a Prescription Drug User Fee Act action date of Feb. 25, 2019. If approved, the product would be the lowest concentrated loteprednol ophthalmic corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. The company says this investigative product uses a novel submicron particle to help increase ocular penetration and residence time in anterior segment tissues. Read more.

Source: Bausch + Lomb, July 2018


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