Volume 12, Number 12
December 2016

WELCOME to Review of Ophthalmology's Retina Online e-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.

Ophthotech Phase III Trials of Fovista: Primary Endpoint Not Met
Ophthotech Corp. announced that the pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in its two pivotal Phase III clinical trials investigating the superiority of Fovista (pegpleranib) anti-PDGF therapy in combination with Lucentis (ranibizumab) anti-VEGF therapy compared with Lucentis monotherapy for the treatment of wet age-related macular degeneration...

Novartis' Lucentis Receives EU approval in New Indication
Novartis announced that the European Commission granted an additional indication for Lucentis (ranibizumab) to treat individuals with visual impairment due to choroidal neovascularization associated with causes other than neovascular age-related macular degeneration, or secondary to pathologic myopia...

And More...


Responses to Intravitreal Bevacizumab, Ranibizumab & Aflibercept Injections for nAMD

In a retrospective study, researchers examined 232 eyes of 232 individuals who received intravitreal anti-vascular endothelial growth factor injections due to treatment-naïve nAMD. All individuals, who were followed-up for at least one year, were treated with intravitreal injections monthly until three months, then as needed. Researchers evaluated the effects of intravitreal injections for treatment of nAMD using the central macular thickness, subretinal fluid, pigment epithelial detachment size and best-corrected visual acuity.

CMT, SRF, PED size and BCVA (LogMAR) significantly decreased after treatment with all three anti-VEGF agents. Overall, the bevacizumab, ranibizumab and aflibercept treatments showed no significant differences in responses. However, the aflibercept injections decreased PED size more quickly than bevacizumab injections (p=0.034).

Researchers concluded that bevacizumab, ranibizumab and aflibercept injections were effective for nAMD and had similar responses, although the number of injections of aflibercept was fewer than other anti-VEGF agents. They suggested that aflibercept injections may be a better choice than other anti-VEGF agents for cases of severe increases in PED height.

SOURCE: Park DH, Hae Sun HJ, Lee SJ, et al. A comparison of responses to intravitreal bevacizumab, ranibizumab, or aflibercept injections for neovascular age-related macular degeneration. Int Ophthalmol 2016; Nov 8. [Epub ahead of print].

Ranibizumab for Vascularized Pigment Epithelial Detachment

Investigators assessed the anatomical and functional efficacy of ranibizumab on vascularized pigment epithelial detachment secondary to neovascular age-related macular degeneration.

They retrospectively selected 109 individuals (116 eyes) from the medical records of 2,097 individuals who received intravitreal injections between January 2011 and June 2013 in a tertiary-care, university-based ophthalmology department. Inclusion criteria were: nAMD; treatment-naive eyes; presence of V-PED higher than 250 μm; intravitreal ranibizumab with a loading phase, followed by a pro re nata regimen and one-year follow-up. Investigators analyzed baseline characteristics and type of choroidal neovascularization, and measured PED height, central macular thickness and best-corrected visual acuity measured at baseline, and months three, six and 12.

CNV was: type 1 in 91 eyes (78.4 percent); type 2 in seven eyes (6 percent); type 3 in six eyes (5.2 percent); and polypoidal choroidal vasculopathy in 12 eyes (10.3 percent). Mean CMT at baseline was 572.1 μm and decreased to 396.6 μm (p<0.0001) at 12 months. Mean height of PED was 458.2 μm at baseline and 306.8 μm (p<0.0001) at 12 months. Mean BCVA improved from 0.46 at baseline to 0.39 at 12 months (p=0.013).

Investigators determined that treatment with ranibizumab improved visual and anatomical outcome in nAMD patients with V-PED.

SOURCE: Chevreaud O, Oubraham H, Cohen SY, et al. Ranibizumab for vascularized pigment epithelial detachment: 1-year anatomic and functional results. Graefes Arch Clin Exp Ophthalmol 2016; Dec 3. [Epub ahead of print].

Efficacy & Safety of Intravitreal Conbercept Injections in ME Secondary to RVO

Investigators assessed the efficacy and safety of intravitreal conbercept injections in individuals with macular edema secondary to retinal vein occlusion, as part of a prospective, Phase II clinical trial.

Sixty subjects with macular edema secondary to RVO received injections. Thirty subjects had branch RVO and 30 had central RVO. Each individual received intravitreal injections of conbercept monthly for up to three months, followed by monthly evaluation and pro re nata injection to month nine.

The average change of best-corrected visual acuity from baseline to month nine was 17.83 ±10.89 letters in BRVO and 14.23 ±11.74 letters in CRVO. The change in BCVA was not statistically different between the groups (p=0.216). The mean reduction of central retina thickness from baseline to month nine was 289.97 ±165.42 µm and 420.47 ±235.89 µm in BRVO and CRVO, respectively. The mean number of injections was 7.14 ±1.90 in BRVO and 7.59 ±1.39 in CRVO from baseline to month nine (p=0.4705). Seven serious adverse events occurred in five individuals (8.33 percent, two BRVO and three CRVO). All the SAEs were nonocular and weren’t related to the drug or the injection procedure.

Intravitreal injections of conbercept demonstrated a generally favorable safety and tolerability profile as well as efficacy in the treatment of macular edema due to RVO, investigators found.

SOURCE: Sun Z, Zhou H, Lin B, et al. Efficacy and safety of intravitreal conbercept injections in macular edema secondary to retinal vein occlusion. Retina 2016; Nov 23. [Epub ahead of print].

Incidence & Risk Factors for Developing DR Among Juvenile Type 1 & Type 2 Diabetes

Researchers sought to identify risk factors for DR in youth subjects with diabetes mellitus, to compare DR rates for juvenile type 1 diabetes mellitus (T1DM) and those with T2DM, and to assess whether adherence to DR screening guidelines promoted by the American Academy of Ophthalmology, American Academy of Pediatrics and American Diabetes Association adequately capture youths with DR.

In the retrospective observational longitudinal cohort study, researchers included subjects ages ≤21 years with newly diagnosed T1DM or T2DM who were enrolled in a large U.S. managed care network.

Researchers identified the incidence and timing of DR onset. Kaplan-Meier survival curves assessed the timing of initial diagnosis of DR, and multivariable Cox proportional hazard regression modeling identified factors associated with the hazard of developing DR. Model predictors were age and calendar year at initial diabetes mellitus diagnosis, sex, race/ethnicity, net worth and glycated hemoglobin A1c fraction. Main outcome measures included hazard ratios with confidence intervals for developing DR.

Among the 2,240 subjects with T1DM and 1,768 subjects with T2DM, 20.1 percent and 7.2 percent developed DR over a median follow-up time of 3.2 and 3.1 years, respectively. Survival curves demonstrated that children with T1DM developed DR faster than those with T2DM (p<0.0001). For every 1-point increase in HbA1c, the hazard for DR increased by 20 percent (HR=1.20; CI, 1.06-1.35) and 30 percent (HR=1.30; CI, 1.08-1.56) among cases of T1DM and T2DM, respectively. Current guidelines suggest that ophthalmic screening begin three to five years after initial diabetes mellitus diagnosis, at which point in this study >18 percent of youths with T1DM had already received ≥1 DR diagnosis.

Researchers determined that juvenile T1DM or T2DM cases exhibited a considerable risk for DR and suggested they should undergo regular screenings by eye-care professionals to ensure timely DR diagnosis and limit progression to vision-threatening disease.

SOURCE: Wang SY, Andrews CA, Herman WH, et al. Incidence and risk factors for developing diabetic retinopathy among youths with type 1 or type 2 diabetes throughout the United States. Ophthalmology 2016; Nov 30. [Epub ahead of print].

Comparison of DR Classification Using FA & OCTA

Scientists analyzed and compared the classification of eyes with diabetic retinopathy using fluorescein angiography and optical coherence tomography angiography performed with AngioPlex (Carl Zeiss Meditec) or AngioVue (Optovue), as part of an observational, cross-sectional study of 50 eyes from 26 diabetic subjects. One of the investigators is an employee of Carl Zeiss Meditec.

Two independent graders classified the FA angiograms to assess the presence and severity of several characteristics according to the ETDRS Report 11; a similar evaluation was performed for each 3×3-mm OCTA image from the superficial retinal layer and for the full retina slab.

Percentages of non-gradable images for the outline of the foveal avascular zone in the central subfield were 29 percent for FA, 12 percent for AngioVue and 3 percent for AngioPlex. For capillary loss, percentages of non-gradable images in the CSF were 25 percent for FA, 11 percent for AngioVue and 0 percent for AngioPlex. For the inner ring, percentages of non-gradable images were 12.5 percent for FA, 11.5 percent for AngioVue and 0.5 percent for AngioPlex. Agreement between graders was substantial for the outline of the FAZ. For capillary loss, the agreement was fair for the CSF and moderate for the IR.

Scientists determined that OCTA allowed for better discrimination of the CSF and parafoveal macular microvasculature than FA, especially for FAZ disruption and capillary dropout, without requiring an intravenous injection of fluorescein. In addition, FA had a higher number of non-gradable images. Scientists advised that OCTA could replace the FA as a noninvasive and more sensitive procedure for detailed morphological evaluation of central macular vascular changes.

SOURCE: Soares M, Neves C, Pereira Marques I, et al. Comparison of diabetic retinopathy classification using fluorescein angiography and optical coherence tomography angiography. Br J Ophthalmol 2016; Dec. 7. [Epub ahead of print].

Reproducibility of Vessel Density Measurement in Eyes With & Without Retinopathy Via OCTA

Researchers determined the intravisit and intervisit reproducibility of optical coherence tomography angiography measurements of macular vessel density in eyes with and without retinal diseases using Angiovue (Optovue). Two of the researchers are consultants for Optovue.

Fifteen healthy volunteers and 22 people with retinal diseases underwent repeated OCTA scans after pupil dilation on two separate visit days. For each visit day, the eyes were scanned twice. Researchers used Angiovue software to calculate vessel density, which was defined as the proportion of vessel area with flowing blood over the total measurement area. They summarized the intravisit and intervisit reproducibility as coefficients of variation, and calculated intraclass correlation coefficients from variance component models.

The coefficients of variation representing the intravisit reproducibility of the superficial macular vessel density measurements for different quadrants on 3-mm x 3-mm scans varied from 2.1 percent to 4.9 percent in healthy eyes, and 3.4 percent to 6.8 percent in diseased eyes. For the intervisit, variation ranged from 2.9 percent to 5.1 percent in healthy eyes, and 4 percent to 6.8 percent in diseased eyes. The coefficients of variation were lower in healthy eyes than in diseased eyes, lower for intravisit than for intervisit, lower on 3-mm x 3-mm scans than on 6-mm x 6-mm scans and lower for paracentral subfields than for central subfields.

Researchers wrote that the evidence demonstrated good reproducibility of OCTA for measurement of superficial macula vessel density in healthy eyes and eyes with diabetic retinopathy without diabetic macular edema.

SOURCE: You Q, Freeman WR, Weinreb RN, et al. Reproducibility of vessel density measurement with optical coherence tomography angiography in eyes with and without retinopathy. Retina 2016; Dec. 7. [Epub ahead of print].

Novel Findings on OCTA in Tubercular Serpiginous-like Choroiditis

Investigators analyzed and described the imaging characteristics of tubercular serpiginous-like choroiditis using optical coherence tomography angiography and compared the findings with multimodal imaging.

As part of the prospective, cross-sectional study, investigators performed multimodal imaging in subjects with tubercular serpiginous-like choroiditis using OCTA (Optovue RTVue XR Avanti), enhanced-depth imaging OCT (Heidelberg Spectralis), fundus autofluorescence, fluorescein angiography and indocyanine green angiography. They analyzed distinct morphologic features of the retinochoroidal vasculature at the sites of choroiditis lesions on OCTA imaging, and performed multimodal imaging to study the changes observed on OCTA.

Eighteen eyes (18 subjects, 16 males) were included in the study. En face OCTA images demonstrated discrete areas of flow void beneath the retinal pigment epithelium-Bruch’s membrane layer suggestive of choriocapillaris hypoperfusion that corresponded well with indocyanine green angiography, especially in the chronic phase. Additional information such as areas of preserved choriocapillaris, vascular tufts and tangled vessels were observed using OCTA among lesions in advanced stages of healing. Compared with indocyanine green angiography, the areas of choriocapillaris atrophy appeared better defined on OCTA and correlated well with enhanced-depth imaging OCT.

Investigators noted that the OCTA images provided high-resolution structural information of the retinochoroidal vasculature in tubercular serpiginous-like choroiditis. As well, they found that the morphologic information obtained from OCTA images correlated well with, and supplemented, other imaging techniques such as indocyanine green angiography and enhanced-depth imaging OCT.

SOURCE: Mandadi SK, Agarwal A, Aggarwal K, et al. Novel findings on optical coherence tomography angiography in patients with tubercular serpiginous-like choroiditis. Retina 2016; Dec. 7. [Epub ahead of print].

Visual Function Correlates of Foveal Slope Changes on OCT in Macular Telangiectasia Type 2

Scientists evaluated changes in foveal and parafoveal thickness measured using optical coherence tomography across five stages of macular telangiectasia 2 and correlated the foveal slope angle with best-corrected visual acuity, as part of a multicenter, cross-sectional study of 90 individuals with bilateral MacTel 2.

They reviewed the medical records of individuals who had undergone OCT, and noted foveal and subfoveal mean retinal thickness from Early Treatment Diabetic Retinopathy Study mapping, which was later used for calculating foveal slope angle. They assessed change in retinal thickness and foveal angle across five stages of MacTel 2, and correlated central foveal thickness and foveal slope angle with BCVA.

The foveal slope angles were calculated quadrantwise and stagewise. The mean slope angle was minimum in temporal quadrant (6.29 degrees) followed by inferior (7.13 degrees), superior (7.54 degrees) and nasal (7.93 degrees). The slope angles were 9.27 degrees, 7.95 degrees, 6.70 degrees, 6.10 degrees and 6.31 degrees in stages 1, 2, 3, 4 and 5, respectively. Statistically significant correlation noted between the temporal, superior, inferior slope angles and BCVA (in logarithm of the minimum angle of resolution) was r=-0.18, -0.19 and -0.25, respectively (p<0.05). No statistically significant correlation was noted between central retinal thickness and BCVA.

The scientists found that BCVA correlated better with slope angles than central retinal thickness, which they wrote suggested that change in both foveal and parafoveal regions accounted for vision change. Further, they wrote, the greater the foveal slope angle, the better the vision.

SOURCE: Jaisankar D, Raman R, Gondhale H, et al. Visual function correlates of foveal slope changes on optical coherence tomography in macular telangiectasia type 2. Retina 2016; Dec. 7. [Epub ahead of print].

Rate & Risk Factors for Conversion of Fovea-on to Fovea-off RRD in Pre-surgery

Investigators assessed progression of a fovea-on to a fovea-off rhegmatogenous retinal detachment in cases awaiting surgery as part of a retrospective review of patient records to identify individuals in whom a fovea-on retinal detachment at presentation was found to be fovea-off at surgery.

Investigators identified 10 cases over 14 years that converted from fovea-on to fovea-off RRD while awaiting surgery. This represented 1.1 percent of RRDs that were fovea-on at presentation (n=930). Nine out of 10 individuals had superotemporal RRDs extending to at least the vascular arcade at presentation, and all had superotemporal breaks within a detached retina, at a significantly higher rate than other retinal detachments (100 percent vs. 63 percent, p=0.02). Investigators found 2.4 breaks per eye, similar to other retinal detachments. Six individuals converted to a fovea-off retinal detachment within a few hours, and the rest by the following day. Visual outcomes were good, with eight individuals maintaining their presenting visual acuity and two losing one Snellen line.

Investigators wrote that offering same-day surgery to high-risk fovea-on RRDs might not significantly influence visual outcomes and would likely only prevent about half of the conversions to fovea-off. They added that superotemporal retinal detachments extending to near the arcades are most at risk and might warrant action to limit spread of the detachment in the preoperative period.

SOURCE: Kontos A, Williamson TH. Rate and risk factors for the conversion of fovea-on to fovea-off rhegmatogenous retinal detachment while awaiting surgery. Br J Ophthalmol 2016; Dec. 2. [Epub ahead of print].

Cataract Surgery in Children With ROP: Surgical Outcomes

Researchers reported the outcomes of cataract surgery in children with retinopathy of prematurity, as part of a retrospective case review of all children diagnosed with ROP from January 2001 to December 2014, and included those who underwent cataract surgery.

Of 2,258 children diagnosed with ROP, 28 eyes of 22 children were included, 14 boys and eight girls. Mean age at cataract surgery was 18.9 months (range: 2 months to 12 years). Most common grade of ROP was stage 4 (13 eyes). Nineteen eyes underwent retinal surgery, scleral buckle (one eye) and laser (three eyes). Five eyes showed spontaneous regression. Mean duration for the development of cataract post-retinal surgery was 7.76 months (range: 2 to 32 months). Nine eyes didn’t receive a primary intraocular lens. Intraoperative posterior capsular rupture occurred in two eyes. Postoperative complications included visual axis opacification (four), secondary glaucoma (two) and IOL capture (one). Postoperative visual acuity assessment was possible in 23 eyes, 11 had better than 20/200 vision. Eleven individuals had a follow-up of at least two years, and the mean myopic shift at two years was -3.07 D in pseudophakes and -8.75 D in aphakes.

Researchers found that cataracts could develop in children with ROP regardless of the modality of intervention, and that postoperative complications and refractive changes were similar to those in eyes without ROP.

SOURCE: Nkemdilim Ezisi C, Kekunnaya R, Jalali S, et al. Cataract surgery in children with retinopathy of prematurity (ROP): Surgical outcomes. Br J Ophthalmol 2016; Dec. 9. [Epub ahead of print].


Ophthotech Phase III Trials of Fovista: Primary Endpoint Not Met

Ophthotech Corp. announced that the pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in its two pivotal Phase III clinical trials investigating the superiority of Fovista (pegpleranib) anti-PDGF therapy in combination with Lucentis (ranibizumab) anti-VEGF therapy compared with Lucentis monotherapy for the treatment of wet age-related macular degeneration. The addition of Fovista to a monthly Lucentis regimen did not result in benefit, as measured by the mean change in visual acuity at the 12-month time point. The two clinical trials (OPH1002 and OPH1003) were international, multicenter, randomized, double-masked, controlled Phase III studies evaluating the safety and efficacy of 1.5 mg of Fovista administered in combination with Lucentis (Fovista combination therapy) compared with Lucentis monotherapy. Read more.

Source: Ophthotech Corp., December 2016

Novartis' Lucentis Receives EU approval in New Indication

Novartis announced that the European Commission granted an additional indication for Lucentis (ranibizumab) to treat individuals with visual impairment due to choroidal neovascularization associated with causes other than neovascular age-related macular degeneration, or secondary to pathologic myopia. With this approval, Lucentis is the first retinal treatment approved for these conditions, which include uveitis, central serous chorioretinopathy, angioid streaks, trauma, retinal or macular dystrophies, and CNV with no apparent cause (idiopathic). Read more.

Source: Novartis, December 2016

TSRI Scientists Find Mechanism Behind Anti-VEGF Treatment Side Effects

Medication composed of VEGF inhibitors may actually add to the problem in some patients, according to research co-led by scientists at The Scripps Research Institute. The new study in animal models suggests that some therapies for age-related wet macular degeneration may leave the eyes and kidneys of some patients vulnerable to cellular damage by hampering the body’s ability to make a protective molecule called inhibitory complement factor H (CFH). The findings were published Dec. 5 online in the Journal of Clinical Investigation. Scientists in previous studies observed that eye and kidney disease patients frequently had a polymorphism that decreased their ability to produce functional CFH, leaving cells vulnerable to damage. This observation led researchers to study anti-VEGF medication’s connection to side effects in the eyes and the kidneys; the team concluded that vascular endothelial growth factor inhibitors appeared to cause unintended consequences as a result of VEGF inhibition and a reduction in CFH synthesis. In addition, CFH synthesis ceased in the eye’s retinal pigment epithelium cells and glomerulus cells without VEGF. Furthermore, models with the CFH polymorphism were more vulnerable to cellular damage. The researchers also created RPE cells from induced pluripotent stem cells and observed that cells with the CFH mutation responded differently to VEGF inhibition. The researchers believe doctors should take steps to reduce VEGF inhibitor treatments that don’t appear to be working and consider screening patients for the CFH mutation. Read more.

Source: The Scripps Research Institute, December 2016

Spark Therapeutics Adds Chief Operating Officer

Spark Therapeutics, a company developing gene therapies that address inherited retinal and other diseases, announced the appointment of John Furey to the newly created position of chief operating officer. Furey will be responsible for global commercial operations, medical affairs, technology development and technical operations. He will report to Jeffrey D. Marrazzo, chief executive officer. Read more.

Source: Spark Therapeutics, December 2016

Jorn Joins pSivida

pSivida Corp. announced that Deb Jorn joined the company as executive vice president of corporate and commercial development, a newly created position reporting directly to Nancy Lurker, pSivida's president and chief executive officer. Jorn's primary responsibilities will be to establish collaborations leveraging pSivida's technologies and finalizing an EU partnership deal for Durasert for glaucoma, a long-term, sustained-release implant delivering latanoprost. Most recently, Jorn was EVP and company chair at Valeant Pharmaceuticals, and previously served as chief marketing officer at Bausch + Lomb. Earlier, she was group VP of Womens' Healthcare and Fertility at Schering Plough. Read more.

Source: pSivida Corp., November 2016

ARVO Launches Outreach Campaign

The Association for Research in Vision and Ophthalmology has produced a series of short videos, educational tools and advocacy resources on the discovery and development of optical coherence tomography. The public-friendly videos feature testimonials from patients, clinicians and researchers describing how OCT improves the diagnosis and monitoring of diseases such as glaucoma, macular degeneration, retinopathy of prematurity and diabetic eye disease. Read more.

Source: Association for Research in Vision and Ophthalmology, November 2016

California Debuts Certified Ophthalmic Education Program

The University of Southern California Roski Eye Institute will offer the first educational program in California, one of only 14 programs nationwide, to train certified ophthalmic technicians with its Ophthalmic Technician Education Program beginning in January 2017. The USC OTEP will create skilled allied health professionals who guide patients and families on understanding their vision conditions, help ensure compliance with treatment protocols, and conduct various tests and procedures that inform ophthalmologists in the diagnosis and treatments of eye diseases and vision conditions. The 21-month program includes academic coursework as well as clinical setting training from experts at the USC Roski Eye Institute. Read more.

Source: USC Roski Eye Institute, December 1, 2016

Dr. Link Joins Allegro Board

Allegro Ophthalmics, a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases, announced that William J. Link, PhD, was elected to Allegro's board of directors. Dr. Link is co-founder and a managing director of Versant Ventures, a global health care investment firm where he specializes in early-stage investing in medical devices. Prior to Versant, Dr. Link was a general partner at Brentwood Venture Capital. With more than two decades of operations experience in the health-care industry, Dr. Link has a proven record of building and managing large, successful medical product companies, including Chiron Vision where he was co-founder, chairman and CEO until it was sold to Bausch + Lomb in 1997. In addition, he founded and served as president of American Medical Optics. Read more.

Source: Allegro Ophthalmics, November 2016

Vitreous Gel Could Hold Clues to Visual Impairment

Research is underway at the Rochester Institute of Technology that will give scientists a better understanding of the vitreous humor, which could lead to advances in the treatment of vision disorders, drug delivery and eye surgery. The Das National Science Foundation-funded study is exploring properties critical to the function of the vitreous and eye. Researchers are investigating changes in the vitreous gel on structural and mechanical levels that result in vision impairment, and the team will use experimental and theoretical methods to investigate the biophysical origin of vitreous-related pathologies. Read more.

Source: Rochester Institute of Technology, November 2016

jCyte Completes Enrollment for Phase I/IIa Safety Trial

jCyte completed enrollment in a Phase I/IIa trial to study the safety of its stem cell therapy candidate for retinitis pigmentosa. The trial includes 28 individuals with advanced RP, eight of whom have completed the one-year study. The company’s investigational therapy, jCell, uses injected retinal progenitor cells to rescue dying retinal cells and possibly regenerate new ones. The nonsurgical treatment requires a single intravitreal injection that can be performed in an ophthalmologist’s office under local anesthesia. The ongoing trial is being conducted at the Gavin Herbert Eye Institute at the University of California, Irvine, and Retina Vitreous Associates in Los Angeles, and has received support from the California Institute for Regenerative Medicine. As the safety trial winds up, jCyte is planning a Phase IIb trial for a possible start date in 2017. Read more.

Source: jCyte, November 2016

Persavita Receives U.S. Patent for Saffron 2020 Eye Health Formula

Persavita announced the issue of a United States patent for its flagship natural eye health product, Saffron 2020, a nutritional supplement approved to help maintain eyesight and support eye health in age-related macular degeneration and cataracts. The patent recognizes the benefits for AMD of the combination of saffron and resveratrol. Persavita says Saffron 2020's vegetarian, gluten-free capsules provide optimal levels of important eye-health ingredients, including 20 mg of high-quality saffron. The company says that Saffron is a "super spice" clinically shown to improve vision in patients with dry form of AMD by changing the way genes work together to repair and maintain cells in the retina of the eye. Saffron 2020 also contains resveratrol, a gene-modulating, natural ingredient that helps protect the retina, along with macular carotenoids lutein and zeaxanthin, which have been shown to affect visual performance. Read more.

Source: Groupe Persavita, November 2016

Compact Navilas Laser System 577s Receives FDA Clearance

OD-OS received United States Food and Drug Administration 510(k) clearance and immediate U.S. commercial availability of the Navilas 577s, a compact, all-digital system for navigated focal and peripheral laser treatments. The system enables physicians to digitally pre-plan laser therapy on fundus images as well as external diagnostic images, and precisely execute the therapy plan under computer guidance. It offers focal treatments without a contact lens and infrared illumination, for increased patient comfort. A large field of view and assisted pattern positioning improve speed in panretinal and focal treatments. Read more.

Source: OD-OS Inc., November 2016

Ohr Announces Pricing of Public Offering of Common Stock

Ohr Pharmaceutical priced a registered public offering of an aggregate of 3,875,000 shares of common stock at a price to the public of $2.00 per share. The total gross proceeds of the offering are expected to be approximately $7,750,000, excluding proceeds from the exercise of the warrants. The company intends to use net proceeds for working capital and other general corporate purposes, including Phase III clinical trials of Squalamine.

Source: Ohr Pharmaceutical, December 2016


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