Review of Ophthalmology's Retina Online

FROM THE EDITORS OF REVIEW OF OPHTHALMOLOGY AND RETINA SPECIALIST:


Volume 14, Number 9
September 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.




Apellis Announces First Patient Dosed In Phase III Trials For Apl-2 In GA
Apellis commenced its Phase III clinical program for APL-2 in individuals with geographic atrophy, consisting of two Phase III trials (DERBY and OAKS), with the first subject dosed in OAKS, and the first subject enrolled in DERBY. The trials will assess the safety and efficacy of multiple intravitreal injections of APL-2 in individuals with GA...


Heidelberg OCTA Module Now Available in United States
Heidelberg Engineering announced today that it received U.S. FDA clearance for its OCT Angiography Module...

And More...

Macular Morphology and VA in Year Five of CATT

Investigators evaluated associations of morphologic features with five-year visual acuity in the Comparison of Age-related Macular Degeneration Treatments Trials, as part of a cohort study.

CATT participant eyes with AMD-associated choroidal neovascularization and VA between 20/25 and 20/320 were eligible. Treatment was assigned randomly to ranibizumab or bevacizumab, to three dosing regimens for two years and at the ophthalmologists’ discretion thereafter.

Main outcome measures included: VA; thickness and morphological features on optical coherence tomography; lesion size; and foveal composition on fundus photography and fluorescein angiography.

VA and image gradings were available for 523 of 914 participants (57 percent) alive at five years. At five years:
• Sixty percent of eyes had intraretinal fluid, 38 percent had subretinal fluid, 36 percent had subretinal pigment epithelium fluid and 66 percent had subretinal hyperreflective material.
• Mean foveal center thickness was 148 ±99 µm for retina, 5 ±21 µm for SRF, 125 ±107 µm for subretinal tissue complex, 11 ±33 µm for SHRM and 103 ±95 µm for RPE+RPE elevation.
• SHRM, thinner retina, greater CNV lesion area and foveal center pathology (all p<0.001) and IRF (p<0.05) were independently associated with worse VA.
• Adjusted mean VA letters was 62 for no pathology in the foveal center; 61 for CNV, fluid or hemorrhage; 65 for non-geographic atrophy, 64 for non-fibrotic scar, 53 for GA and 56 for fibrotic scars.
• Incidence or worsening of eight pathological features (foveal GA, scar and CNV; SHRM, foveal IRF, retinal thinning, CNV lesion area and GA area) between years two and five were independently associated with greater VA loss between those years, and between baseline and year five.

Investigators found that associations between VA and morphologic features previously identified through year one were maintained or strengthened at year five. They also determined that new foveal scars, CNV, intraretinal fluid, SHRM and retinal thinning; development or worsening of foveal GA; and increased lesion size were important contributors to VA decline from year two to five. Investigators suggested that new therapies were needed to address these adverse pathological features.

SOURCE: Jaffe GJ, Ying G-S, Toth CA, et al. Macular morphology and visual acuity in year five of the Comparison of Age-related Macular Degeneration Treatments Trials (CATT). Ophthalmology 2018; Sept. 3. [Epub ahead of print].


 

Acuity Outcomes Based on Initial Treatment Response in nAMD

Researchers explored various methods to assess the early response to vascular endothelial growth factor inhibitors for neovascular age-related macular degeneration, and investigated associations with three-year visual acuity outcomes, as part of an observational study.

The study included 2,051 treatment-naïve eyes from 1,828 individuals in the Fight Retinal Blindness! outcomes registry receiving anti-VEGF therapy between Jan. 1 2007, and March 1, 2014, and specifically injections within the first three months.

Researchers defined early response as occurring before the fourth injection. They analyzed various early response metrics, including continuous and categorical variables such as:
• good VA (≥70 letters [20/40]);
• absolute change in VA from baseline;
• inactivity during time to first grading of the choroidal neovascular lesion; and
• maximum rate of VA change between successive injections. Main outcome measures included the proportion of eyes achieving ≥70 letters at three years.

Achieving good vision at three years was significantly associated with:
• having good vision by the fourth injection (OR [CI]: 9.8 [6.5, 14.7] for VA ≥70 vs. VA <70 letters);
• small (1 to 5 letters) or large (>5 letters) early VA gains (1.8 [1.2, 2.6], p=0.002 and 1.8 [1.3, 2.5], p<0.001 vs. eyes with early VA loss);
• fewer injections until grading of lesion inactivity (1.6 [1.2, 2.1], p<0.001 for ≤3 vs. >3 injections); and
• gradual change (between -4 and 4 letters) or rapid (>5 letters) gains between successive injections (1.7 [1.1, 2.6], p=0.015 and 1.6 [1.1, 2.3], p=0.018 for gradual change and rapid gain vs. rapid loss).
• Eyes that achieved small or large early gains (65 letters) achieved similar vision at three years (64.7 letters), and had better vision than eyes with early VA loss (57.2 letters).

Attainment of good vision by the fourth injection was strongly associated with three-year visual outcomes, while other early response parameters had a moderate association. Researchers determined that the early response during the initial three monthly loading doses could be a useful guide for subsequent treatment decisions.

SOURCE: Nguyen V, Daien V, Guymer R, et al. Projection of long-term visual acuity outcomes based on initial treatment response in neovascular age-related macular degeneration. Ophthalmology 2018; Aug 24. [Epub ahead of print].

 

 

Long-Term Effectiveness of Continued Ranibizumab in NAMD vs. Switch to Aflibercept

In a study sponsored by Novartis (which markets ranibizumab outside of the United States), researchers evaluated the long-term comparative effectiveness of ranibizumab compared with a switch to aflibercept in neovascular age-related macular degeneration, as part of a 24-month, retrospective, comparative, nonrandomized, matched cohort analysis.

Participants included subjects with nAMD initiated on ranibizumab who remained (non-switchers) or those who switched to aflibercept, captured from a U.S. electronic medical records database between July 1, 2011, and Oct 12, 2014.

Subject eyes were matched on baseline age, baseline visual acuity, VA at month three and duration of follow-up. Matching ratio was 1:2 (switchers:non-switchers) where possible and 1:1 otherwise.

The primary outcome was VA change from baseline (first injection of ranibizumab) to month 24. Secondary endpoints were area under the ROC curve of VA change; eyes (percentage) gaining or losing ≥5, ≥10 or ≥15 letters; or VA >73 letters at month 24, number of injections and monitoring visits, and pre-switch characteristic analyses.

A total of 454 switchers and 750 matched non-switchers were included. The adjusted difference in mean VA change from baseline to month 24 for switchers to non-switchers was 0.02 (CI, -1.63, 1.68) letters. The upper bound CI (1.68) was below the predefined non-inferiority margin of five letters. Switchers had a significantly higher annualized number of mean total visits compared to non-switchers (10 vs. 9 for year one; 8.7 vs. 7.4 for year two), a higher number of injection visits (8.4 vs. 6.7 for year one; 7 vs. 5.1 for year two), but a lower number of monitoring-only visits (1.6 vs. 2.3 for year one; 1.7 vs. 2.3 for year two). During the pre-switch period, switchers had a higher number of injection visits (7.6 vs. 6.5), fewer monitoring-only visits (1.5 vs. 2.2) and comparable total visits (9.1 vs. 8.7). VA change from baseline to switch was similar between switchers and non-switchers (adjusted LS mean difference -1.36 [CI, -2.76; 0.05] letters).

Researchers found that switching patients from ranibizumab to aflibercept resulted in no difference in VA change compared with those maintained on ranibizumab only. They suggested that the lower re-treatment rate in non-switchers compared with switchers post-switch didn’t support the view of longer treatment efficacy.

SOURCE: Chakravarthy U, Bezlyak V, Sagkriotis A, et al. Real-world evidence of the long-term comparative effectiveness of continued ranibizumab therapy in nAMD versus a switch to aflibercept. Ophthalmology Retina 2018; Sept. 14. [Epub ahead of print].






RPE Hyperplasia Overlying PED in AMD Can Masquerade as Neovascularization on OCTA

Investigators reported that image artifacts due to retinal pigment epithelium hyperplasia overlying retinal pigment epithelial detachment in age-related macular degeneration can masquerade as neovascularization on optical coherence tomography angiography.

The hospital-based, retrospective and cross-sectional study included 22 eyes from 16 subjects with non-vascularized PED related to AMD. All subjects were examined by OCTA, spectral-domain OCT, fluorescein angiography and indocyanine green angiography. Investigators evaluated vascular flow signals on the outer retinal slab of en face OCTA and cross-sectional OCTA images, and their correspondence with RPE hyperplasia. Here are some of the investigators’ findings:
• Fifteen eyes (68.2 percent) showed VFS on both the outer retina slab of en face OCTA and cross-sectional OCTA, all corresponding with RPE hyperplasia overlying PED. Among them, 12 eyes with lump RPE hyperplasia outside the foveal avascular zone showed obvious VFS on the outer retina slab of OCTA, and three eyes with scattered RPE hyperplasia outside the FAZ showed VFS fragments.
• Four eyes had accompanied RPE hyperplasia inside the FAZ, and seven eyes without RPE hyperplasia overlying PED showed no corresponding VFS on the outer retina slab of OCTA.
• Investigators observed round, dark bands at the edge of PED in the outer retina slab on en face OCTA in 17 eyes (77.3 percent).

The researchers determined that RPE hyperplasia overlying PED in AMD could masquerade as neovascularization on OCTA. They suggested that this RPE hyperplasia-related image artifact should be considered when interpreting OCTA images to avoid misdiagnosis and unnecessary treatment.

SOURCE: Chen L, Zhang X, Yuhong Gan Y, et al. Retinal pigment epithelium hyperplasia overlying pigment epithelial detachment in age-related macular degeneration can masquerade as neovascularization on optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol 2018; Sept. 18. [Epub ahead of print].





Natural History of DPED Associated With AMD

Scientists reviewed the natural history and genetic associations of drusenoid pigment epithelial detachments associated with age-related macular degeneration as part of a retrospective analysis of a prospective cohort study.

Of 4,203 Age-Related Eye Disease Study 2 participants, 391 eyes (325 participants) were identified as having DPED without late AMD at the time of DPED detection. Genetic analyses included 120 white AREDS2 participants and 145 AREDS participants with DPED.

Scientists graded baseline and annual stereoscopic fundus photographs according to a standardized protocol to detect DPED, a well-defined yellow elevated mound of confluent drusen, measuring ≥ 433 µm in diameter, to evaluate progression rates to late AMD (geographic atrophy and neovascular). They investigated five single-nucleotide polymorphisms (CFH [rs10611670], C3 [rs2230199], CFI [rs10033900], C2/CFB [rs114254831] and ARMS2 [rs10490924]) and a genetic risk score group for association with DPED development. They also performed Kaplan-Meier analyses and multivariable proportional hazard regressions.

Main outcome measures included progression rates to late AMD and decrease of ≥ three lines in visual acuity from time of DPED detection. Mean (SD) follow-up time from DPED detection was 4.7 (0.9) years. Scientists reported the following findings:
• Presence of DPED was associated with increased risk of progression to late AMD (hazard ratio=2.36, CI, 1.98 to 2.82,
p
<0.001); 67 percent of eyes progressed to late AMD five years after DPED detection.
• DPED was associated with an increased risk of ≥ three lines of VA loss (HR=3.08, CI, 2.41 to 3.93, p<0.001), with 46 percent of eyes experiencing vision loss at five years (with or without progression to late AMD).
• ARMS2 risk alleles (1 vs. 0: HR=2.72, CI, 1.58 to 4.70, p<0.001; 2 vs. 0: HR=3.16, CI, 1.60 to 6.21, p<0.001) and increasing GRS group (4 vs. 1) (HR=12.17, CI, 3.66 to 40.45, p<0.001) were significantly associated with DPED development in AREDS.
• Scientists found no significant genetic results in the AREDS2 analyses.

Scientists wrote that their findings replicated the results of previous natural history studies of eyes with DPED, including the high rates of progression to late AMD and vision loss (regardless of progression to late AMD). They added that the genetic associations were consistent with genes associated with AMD progression.

SOURCE: Yu JJ, BA, Agrόn E, Clemons TE, et al. Natural history of drusenoid pigment epithelial detachment associated with age-related macular degeneration: Age-Related Eye Disease Study 2 Report No. 17. Ophthalmology 2018; Aug. 22. [Epub ahead of print].





Mineralocorticoid Receptor Antagonists in CSCR

Scientists performed a meta-analysis comparing mineralocorticoid receptor antagonists (eplerenone or spironolactone) vs. observation or placebo in the treatment of central serous chorioretinopathy based on best-corrected visual acuity and subretinal fluid-level data from randomized controlled trials.

They searched three databases (PubMed, EMBASE and BIOSIS) for potentially relevant records as of March 2018. Of 114 unique studies identified, they included five RCTs comparing BCVA with either eplerenone or spironolactone vs. observation or placebo. Scientists assessed the quality of articles according to the Cochrane Risk of Bias Tool with any discrepancies resolved by author consensus.

A total of 145 eyes with CSCR were included. Compared with placebo or observation, MR antagonist treatments had a significant positive effect on BCVA after both one month (weighted mean difference [WMD]=-0.05 logMAR units [CI, -0.07 to -0.02], Z=3.94, p<0.0001) and two months (WMD=-0.10 logMAR units [CI, -0.14 to -0.06], Z=4.69, p<0.00001). MR antagonist treatments also significantly reduced SRF height in CSCR at one month (WMD=-81.15 μm [CI, -148.25 to -14.05], Z=2.37, p=0.02). However, this effect was no longer significant at two months (WMD=-58.63 μm [CI, -155.40 to 38.13, Z=1.19, p=0.23). No individuals in the five trials withdrew due to adverse effects, and blood electrolyte levels including potassium remained normal in all cases.

The scientists wrote that the findings suggested a modest benefit with MR antagonist therapy for individuals with CSCR in improving BCVA. They added that they anticipated that MR antagonists would be well-tolerated in most CSCR cases and that barriers to starting a trial of these medications in non-resolving CSCR should be low.

SOURCE: Wang SK, Sun P, Tandias RM, et al. Mineralocorticoid receptor antagonists in central serous chorioretinopathy: A meta-analysis of randomized controlled trials. Ophthalmology Retina 2018; Sept. 14. [Epub ahead of print].




Complement Levels in Vitreous Aspirates of PDR & RD Eyes

Investigators evaluated levels of complement factors in the vitreous of human eyes with retinal detachments and proliferative diabetic retinopathy. Samples were collected from eyes undergoing routine vitrectomy at the University of Colorado Health Eye Center in Aurora.

Investigators measured complement factor D, component C5/C5a and component C9 levels using enzyme-linked immunosorbent assay and multiplex assays. They compared eyes with retinal detachment and PDR to controls consisting of eyes with macular holes or epiretinal membranes. Levels of complement factor D in PDR (mean=2,110 ng/mL, p=0.001) and RD (mean=660.9 ng/mL, p=0.03) eyes were statistically significantly higher than those of controls (mean=290.5 ng/mL).

Levels of complement component C9 were also more elevated in PDR eyes (p=0.004) compared with controls, though not in RD eyes.

Investigators concluded that elevated complement factors, particularly of the alternative pathway, were noted in PDR and RD eyes compared with controls. They suggested that oxidative stress in RD and PDR eyes might have led to complement dysregulation and alternative complement upregulation.

SOURCE: Manoharan N, Patnaik JL, Olson JL, et al. Increased complement levels in human vitreous aspirates of proliferative diabetic retinopathy and retinal detachment eyes. Retina 2018; Aug. 24. [Epub ahead of print].




Autonomous AI-based Diagnostic System for DR Detection

This trial evaluated an autonomous artificial intelligence system’s ability to detect diabetic retinopathy in 900 subjects with diabetes but no history of DR at primary care clinics. Researchers compared the AI system’s findings with those of FPRC-certified photographers via widefield stereoscopic photography and macular optical coherence tomography at the Wisconsin Fundus Photograph Reading Center, and FPRC grading of Early Treatment Diabetic Retinopathy Study Severity Scale and diabetic macular edema.

More than mild DR (mtmDR) was defined as ETDRS level 35 or higher and/or DME in at least one eye. AI system operators underwent a standardized training protocol before the study started.

The median age was 59 years (range: 22 to 84 years). Among participants: 47.5 percent were male, 16.1 percent were Hispanic, 83.3 percent weren’t Hispanic, 28.6 percent were African American and 63.4 percent weren’t African American. A total of 198 (23.8 percent) had mtmDR.

The AI system exceeded all pre-specified superiority endpoints, with:
• sensitivity of 87.2 percent (CI, 81.8 to 91.2 percent) (>85 percent);
• specificity of 90.7 percent (CI, 88.3 to 92.7 percent) (>82.5 percent); and
• imageability of 96.1 percent (CI, 94.6 to 97.3 percent).

Researchers wrote that these results prompted the FDA to approve the system for clinical use to detect mtmDR and DME, making it the first FDA-approved, autonomous AI diagnostic system in medicine.

SOURCE: Abràmoff MD, Lavin PT, Birch M, et al. Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices. npj Digital Medicine 2018; Aug. 28. [Epub ahead of print].




SS-OCT Facedown Position Post-vitrectomy & Macular Hole Closures

Researchers compared clinical outcomes in eyes with macular hole managed by either facedown (FD) or no-FD (nFD) postoperative positioning protocols, as part of a prospective, randomized cohort study.

Eighty eyes of 80 consecutive individuals with MH that underwent vitrectomy surgery with internal limiting membrane peeling and gas tamponade were included. Forty eyes of 40 individuals kept in FD position for three days after surgery were assigned to the FD group, and 40 eyes of 40 individuals with nFD positioning were assigned to the nFD group. Researchers examined macular holes with swept-source optical coherence tomography images at one day, two days, three days, two weeks, one month and three months after surgery. They compared the MH closure rate and change of best-corrected visual acuity. Below are some of the findings:
• At postoperative day one, MHs were closed in 24 of 32 eyes (with clear OCT images) (75 percent) in the FD group, and 23 of 30 eyes (with clear OCT images) (77 percent) in the nFD group (p=0.97).
• At postoperative day two, MH closures were confirmed in 32 of 36 eyes (88.9 percent) in the FD group and in 31 of 33 eyes (94 percent) in the nFD group (p=0.84); results were unchanged at day three.
• At two weeks post-surgery, clear OCT images were acquired from all eyes in both groups, and MH closures were confirmed in 36 of 40 eyes (90 percent) in the FD group and in 37 of 40 (92.5 percent) eyes in the nFD group (p=0.91).
• Macular hole closures weren’t achieved in eyes kept open by day three post-surgery, and no eyes with confirmed MH closures by day three had reopenings by three months.
• The distribution of macular configurations at three months wasn’t significantly different between the two groups (p=0.96).
• Researchers found no differences in improvement in best-corrected visual acuity (Early Treatment Diabetic Retinopathy Study letters gain) between the two groups at one month (p=0.22) and three months (p=0.45).

Researchers found that the nFD protocol neither delayed MH closures nor decreased the final closure rate after vitrectomy surgery. As such, they suggested that using the prone position postoperatively seemed to be unnecessary for all MH repair procedures

SOURCE: Zhang Y, Chen X, Hong L, et al. Facedown positioning after vitrectomy will not facilitate macular hole closure based on swept-source optical coherence tomography imaging in gas-filled eyes: A prospective, randomized comparative interventional study. Retina 2018; Sep 7. [Epub ahead of print].




Choroidal Structures & Visual Functions in Eyes With Retinitis Pigmentosa

Researchers assessed the choroidal structures in the enhanced depth imaging optical coherence tomographic images in eyes with retinitis pigmentosa, and determined correlations between the choroidal structures and visual functions.

They binarized EDI-OCT images of 100 eyes with typical RP, and 60 age-, sex- and axial length-matched normal eyes using the image-processing program ImageJ, and measured cross-sectional luminal and stromal areas of the inner and outer subfoveal choroid of 1,500-µm width. The inner choroid included the choriocapillaris and medium vessel layer, and the outer choroid included the larger vessel layer.

In the inner choroid, the luminal area and ratio of luminal/total choroidal area (L/C ratio) were significantly smaller in RP (p=0.010) than in controls (p<0.001), whereas the stromal area wasn’t significantly different (p=0.114). The inner choroidal L/C ratio was significantly correlated with best-corrected visual acuity, mean deviation, foveal sensitivity, and width of the ellipsoid zone and central foveal thickness in RP after adjusting for axial length, age and sex (all p<0.005).

Researchers determined that the significant correlations between the inner choroidal structures, and visual functions and retinal structures indicated that the choroidal structures were altered in association with the progression of RP.

SOURCE: Egawa M, Mitamura Y, Niki M, et al. Correlations between choroidal structures and visual functions in eyes with retinitis pigmentosa. Retina 2018; Aug 10. [Epub ahead of print].





 



APELLIS ANNOUNCES FIRST PATIENT DOSED IN PHASE III TRIALS FOR APL-2 IN GA

Apellis commenced its Phase III clinical program for APL-2 in individuals with geographic atrophy, consisting of two Phase III trials (DERBY and OAKS), with the first subject dosed in OAKS, and the first subject enrolled in DERBY. The trials will assess the safety and efficacy of multiple intravitreal injections of APL-2 in individuals with GA. The program, consisting of 600 subjects in two prospective, international, multicenter, randomized, double-masked, sham-injection controlled studies, are similar in design to the company’s Phase II FILLY trial, including the eligibility criteria and primary endpoint of change in GA lesion size from baseline to month 12, compared with sham, the company says. In DERBY and OAKS, individuals will continue on therapy for an additional year. Read more.

Source: Apellis Pharmaceuticals, September 2018



Heidelberg OCTA Module Now Available in United States

Heidelberg Engineering announced today that it received U.S. FDA clearance for its OCT Angiography Module. The Spectralis expandable diagnostic imaging platform now can be upgraded with the OCT Angiography Module to perform noninvasive, layer-by-layer exams of flow in the vascular networks of the retina and choroid. The module can be added to new and existing Spectralis devices with the OCT2 Module. Read more.

Source: Heidelberg Engineering, September 2018





IRIDEX INTRODUCES UPDATED TRUFOCUS LIO PREMIERE LASER ACCESSORY

Following FDA 510(k) clearance, Iridex introduced its updated TruFocus LIO Premiere laser accessory to the U.S. market. The light combination and reflection viewing system used with Iridex retina laser systems is worn on the physician’s head and combines a laser treatment beam from an Iridex laser source with the illumination beam of a binocular indirect ophthalmoscope into a mixed optical beam. The physician uses a handheld ophthalmic exam lens to view and treat the retina through the patient’s pupil. Read more.

Source: Iridex, September 2018





ALLEGRO APPOINTS NEW CEO, TAKES RISUTEGANIB TO PHASE III

Allegro Ophthalmics' board of directors named Vicken Karageozian, MD, as president and chief executive officer. Dr. Karageozian will prepare the company to enter Phase III clinical trials with lead compound risuteganib (Luminate) in diabetic macular edema and continue developing the drug for other retinal disease indications. Dr. Karageozian has more than 25 years' experience in building, leading and raising capital for companies in the ophthalmic pharmaceutical space, Allegro says. Read more.

Source: Allegro Ophthalmics, August 2018





EYEGATE EGP-437 IN ANTERIOR UVEITIS SHOWS EFFICACY BUT NOT NON-INFERIORITY TO CONTROLS

EyeGate Pharmaceuticals announced mixed topline results from its Phase III study evaluating the safety and efficacy of EGP-437 delivered through the EyeGate II Drug Delivery System in individuals with noninfectious anterior segment uveitis. Although EGP-437 showed clinical efficacy, defined as a reduction in anterior chamber cell score throughout the study, EyeGate reports that it didn’t demonstrate non-inferiority to the prednisolone acetate ophthalmic solution control group. This was measured as the proportion of subjects with an anterior cell count of zero (a sign of diminished inflammation) at day 14. EyeGate says it plans to review the data and assess its strategic options for EGP-437 going forward. Read more.

Source: EyeGate Pharmaceuticals, September 2018





ADVERUM IND ACTIVE FOR ADVM-022 NOVEL GENE THERAPY TO TREAT WET AMD

Adverum Biotechnologies announced its Investigational New Drug application is active for the planned multicenter, open-label, Phase I, dose-escalation study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration. The trial is designed to assess the safety and tolerability of a single intravitreal injection of ADVM-022 in individuals with wet AMD who are responsive to anti-vascular endothelial growth factor treatments. Read more.

Source: Adverum Biotechnologies, August 2018





KODIAK COMPLETES FINANCING TO ADVANCE KSI-301

Kodiak Sciences completed a $33 million round of private financing of convertible notes to pay for product development. Kodiak intends to use the proceeds from the financing to advance the development of its lead product candidate, KSI-301, an anti-VEGF therapy for wet age-related macular degeneration and diabetic retinopathy. The novel, pre-IND stage, anti-VEGF biologic therapy is designed to combine inhibition of a known pathway. KSI-301 is built with Kodiak's Antibody Biopolymer Conjugate, or ABC, platform, designed to maintain potent and effective drug levels in ocular tissues. By addressing the primary causes of undertreatment, KSI-301 has the potential to improve and sustain visual acuity outcomes in individuals with neovascular conditions of the retina such as wet AMD and DR. Read more.

Source: Kodiak Sciences, April 2018





ProQR Releases Positive Results from Phase I/II Clinical Trial of QR-110

ProQR Therapeutics announced encouraging results from a planned interim analysis of its Phase I/II trial of QR-110 in individuals with Leber’s congenital amaurosis 10 due to the p.Cys998X mutation in the CEP290 gene. LCA10 typically leads to childhood blindness and has no available treatment options. In the trial, QR-110 demonstrated rapid and sustained improvement in vision in subjects with LCA10, as measured by visual acuity and the mobility course performance, and being well-tolerated with no serious adverse events recorded, the company says. Read more.

Source: ProQR Therapeutics, September 2018





Opthea Reports $1.2 Million Revenues as it Progresses THROUGH Trials

On the heels of increasing its annual revenues by 95 percent to $1.2 million during the 2017-18 financial year, Opthea representatives reported the company is on track to advance its clinical development program for its therapeutic OPT-302 and meet milestones as it investigates the therapy in people with diabetic macular edema and wet age-related macular degeneration, by the year 2020. Company directors reported that, in the next 12 months, Opthea plans to complete patient enrollment for its Phase IIb wet AMD trial and complete the first six-monthly dosing regimen for elderly patients. Read more.

Source: Opthea, August 2018





 

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