Photovoltaic Retinal Implant Shows Early Promise for Geographic Atrophy

This is an exciting new technology that provides vision restoration potential to patients with end stage geographic atrophy. This study demonstrated that the use of photovoltaic cells in the subretinal space is safe, feasible and can lead to improved visual acuity.

source: Ophthalmology
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Summary

Photovoltaic Retinal Implant Shows Early Promise for Geographic Atrophy

[Posted 12/Oct/2020]

AUDIENCE: Ophthalmology, Internal Medicine

KEY FINDINGS: This is an exciting new technology that provides vision restoration potential to patients with end stage geographic atrophy. This study demonstrated that the use of photovoltaic cells in the subretinal space is safe, feasible and can lead to improved visual acuity.

BACKGROUND: This prospective, first-in-human clinical trial assessed the safety and efficacy of a wireless photovoltaic retinal implant (PRIMA; Pixum Vision) in patients with geographic atrophy.

DETAILS: The implant was tested 5 patients with geographic atrophy zone of 3 optic disc diameters or more and BCVA of 20/400 to 20/1,000 in the worse-seeing study eye. Fundus photography and OCT were used to assess anatomic outcomes during the 12-month follow-up. Prosthetic vision was evaluated by mapping light perception, bar orientation, letter recognition and Landolt C acuity testing. The prosthesis was implanted successfully under the macula in all 5 patients, however it was implanted within the choroid of 1 patient and was off center by 2 mm in another patient. None of the patients’ vision declined after placement. All participants could perceive white-yellow prosthetic visual patterns with adjustable brightness in the previous scotomata, which did not perceive light prior to the surgery. The 3 patients with optimal placement of the implant achieved visual acuity of 20/460 to 20/550. This was a small, initial, open-label study with only 5 patients.

Copyright © American Academy of Ophthalmology 2020. All rights reserved.

Source: Ophthalmology Published October 07, 2020.

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Binocular Interference vs Diplopia in Patients With Epiretinal Membrane

Study findings suggest that binocular interference, manifesting as monocular eye closure (without diplopia or strabismus), is a distinct entity affecting quality of life in patients with epiretinal membrane.

source: JAMA

Summary

Binocular Interference vs Diplopia in Patients With Epiretinal Membrane

[Posted 17/Sep/2020]

AUDIENCE: Ophthalmology, Internal Medicine

KEY FINDINGS: In this medical record review of patients with epiretinal membrane, monocular eye closure (sometimes or more; n = 124) was associated with binocular interference (reduced monocular vs binocular visual quality, no diplopia or strabismus) in 36 (29%), central-peripheral rivalry (CPR)–type diplopia in 34 (27%), and other (primarily strabismus) in 54 (44%). Patients with binocular interference were more likely to have reduced quality of life compared with epiretinal membrane patients who never close 1 eye.

BACKGROUND: Patients with epiretinal membrane (ERM) sometimes close 1 eye for improved vision, but associations have not been rigorously studied. Objective of this study is to evaluate associations with monocular eye closure in patients with ERM, and to report binocular interference (closing 1 eye to improve visual quality).

DETAILS: Retrospective medical record review of an adult strabismus clinic at a tertiary referral center. Patients with ERM referred from retina clinicians between June 2010 and October 2019 who completed the Adult Strabismus (AS)–20 questionnaire, including the question: “I cover or close one eye to see things better.” Two groups were identified: (1) patients reporting eye closure sometimes or more, and (2) patients reporting no eye closure (as control patients). Frequencies of (1) central-peripheral rivalry (CPR)–type diplopia (dragged fovea diplopia); (2) binocular interference (monocular eye closure but no diplopia or strabismus); and (3) other, associated with monocular eye closure. Visual acuity, metamorphopsia, aniseikonia, and AS-20 quality of life domain scores (self-perception, interactions, reading function, and general function) compared between binocular interference, CPR-type diplopia, and control patients. A total of 124 patients with ERM (58 of 124 were women [47%]; mean [SD] age, 70 [9] years) reported monocular eye closure. Associations were binocular interference in 36 (29%; 95% CI, 21%-38%), CPR-type diplopia in 34 (27%; 95% CI, 20%-36%), and other (primarily strabismus) in 54 (44%). Compared with control patients with ERM (n = 11), patients with ERM and binocular interference had worse quality of life on AS-20 reading function (95 vs 62; mean difference, 22 points; 95% CI, 7-27 points; P = .007) and general function (89 vs 68; mean difference, 23 points; 95% CI, 13-34 points; P = .01) domains. Compared with CPR-type diplopia, patients with binocular interference had poorer worst-eye visual acuity (median 0.50 vs 0.30 logMAR [20/63 vs 20/40]; mean difference, 0.13 logMAR; 95% CI, 0.00-0.25 logMAR [20/20 to 20/35]; P = .03), and a larger interocular difference (0.46 vs 0.19 logMAR [20/58 vs 20/30]; mean difference, 0.15 logMAR; 95% CI, 0.03-0.28 logMAR [20/21 to 20/38]; P = .004).

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Copyright © 2020 American Medical Association. All Rights reserved.

Source: JAMA Ophthalmol. Published September 10, 2020. doi:10.1001/jamaophthalmol.2020.3328


Topical Therapy Appears Effective for Closing Secondary Macular Holes

Secondary FTMH are infrequent but topical therapy should be considered as treatment, particularly when they are small and cystoid macular edema (CME) is present. The topical treatment has low morbidity, especially relative to surgical repair.

source: Ophthalmology

Summary

Topical Therapy Appears Effective for Closing Secondary Macular Holes

[Posted 01/Sep/2020]

AUDIENCE: Cardiology, Internal Medicine

KEY FINDINGS: Secondary FTMH are infrequent but topical therapy should be considered as treatment, particularly when they are small and CME is present. The topical treatment has low morbidity, especially relative to surgical repair.

BACKGROUND: This retrospective case series included 123 FTMHs treated between 2016 and 2019. The main outcome measures were closure rate of FTMHs and change in visual acuity.

DETAILS: During the 3-year period, researchers identified 12 eyes with secondary FTMH due to mechanisms other than vitreomacular traction, such as prior vitrectomy, trauma and inflammation. The average initial hole diameter was 79 µm (range 44–132 µm) and all holes had elements of epiretinal membrane and cystoid macular edema (CME). Nine eyes were treated with topical difluprednate in addition to topical carbonic anhydrase inhibitor (6 eyes) or bromfenac (2 eyes). Eight holes closed (89%) over an average of 6 weeks. Mean vision improved from 20/100 to 20/50. One hole reopened upon cessation of topical therapy and closed once more when the treatment was restarted. This is a small retrospective series and it is unclear how the patients were selected for the topical therapy. Although difluprednate was consistently used, patients received different drop combinations. There was no comparison group, and although there were small macular holes, the rate of spontaneous closure is unknown.

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Copyright © 2020 American Academy of Ophthalmology. All rights reserved.

Source: Ophthalmology Retina. Published July 2020. https://doi.org/10.1161/JAHA.119.012322


FDA Approves Treatment for Rare Disease NMOSD

FDA approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody - patients who are anti-aquaporin-4 or AQP4 antibody-positive.

source: FDA

Summary

FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

Third FDA-Approved Therapy in Just Over a Year for Neuromyelitis Optica Spectrum Disorder Gives Patients Another Treatment Option

[Posted 20/Aug/2020]

AUDIENCE: Ophthalmology, Neurology, Internal Medicine

The U.S. Food and Drug Administration has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive. NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng is the third approved treatment for the disorder.

“Until last year, there were no FDA-approved treatments for patients with this rare, debilitating and sometimes fatal disease. Now there are three,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Enspryng highlights the FDA’s commitment to rapidly advancing safe and effective therapies for NMOSD and other neurological diseases.”

In patients with NMOSD, the body’s immune system mistakenly attacks healthy cells and proteins in the body, most often those in the optic nerves and spinal cord. Individuals with NMOSD typically have attacks of optic neuritis, which causes eye pain and vision loss. Approximately 50% of patients with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks. Estimates vary, but NMOSD is thought to impact approximately 4,000 to 8,000 Americans.

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NMOSD can be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). Binding of the anti-AQP4 antibody appears to activate other components of the immune system, causing inflammation and damage to the central nervous system.

The effectiveness and safety of Enspryng for the treatment of NMOSD was demonstrated in two 96-week clinical studies. The first study included 95 adult patients; 64 of these patients had antibodies against AQP4 (anti-AQP4 positive). During this study, treatment with Enspryng reduced the number of NMOSD relapses by 74% in patients who were anti-AQP4 positive compared to treatment with a placebo (inactive treatment).

The second study included 76 adult patients; 52 of these patients were anti-AQP4 positive. During the second study, treatment with Enspryng reduced the number of relapses in patients who were anti-AQP4 positive by 78% compared to treatment with a placebo. There was no evidence of a benefit in patients who were anti-AQP4 antibody negative in either trial.

The prescribing information for Enspryng includes a warning for increased risk of infection, including serious and potentially fatal infections – such as potential reactivation of hepatitis B and tuberculosis. Other warnings and precautions for Enspryng include elevated liver enzymes, decreased neutrophil counts and hypersensitivity reactions. The most common side effects observed were the common cold (nasopharyngitis), headache, upper respiratory tract infection, inflammation of the lining of the stomach, rash, joint pain, extremity pain, fatigue and nausea. Vaccination with live-attenuated or live vaccines is not recommended during treatment and should be administered at least four weeks before starting Enspryng.

Enspryng received fast track designation, which expedites the development and review of drugs that are intended to treat a serious condition and demonstrate the potential to address an unmet medical need. The drug also received orphan drug designation, which provides incentives to assist and encourage drug development for rare diseases.

The FDA is granting the approval to Genentech Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Published: August 17, 2020.


Retinal Arterial Occlusion With Multiple Retinal Emboli and Carotid Artery Occlusion Disease

RAOs with multiple emboli are rare but highly associated with severe CAOD with haemodynamic flow changes, warning critical condition in carotid/cerebral circulations.

source: BMJ Open Ophthalmology

Summary

Retinal Arterial Occlusion With Multiple Retinal Emboli and Carotid Artery Occlusion Disease. Haemodynamic Changes and Pathways of Embolism

[Posted 7/Aug/2020]

AUDIENCE: Ophthalmology, Internal Medicine

KEY FINDINGS: RAOs with multiple emboli are rare but highly associated with severe CAOD with haemodynamic flow changes, warning critical condition in carotid/cerebral circulations. Either direct embolism from the carotid or cardiac lesions or indirect embolism via the collateral pathways is the mechanism of pathogenesis. Immediate action should start to manage these patients to prevent further deterioration.

BACKGROUND: To introduce a special subgroup, retinal artery occlusion (RAO) with multiple emboli, which is highly associated with ipsilateral carotid artery occlusion disease (CAOD).

DETAILS: This is a cohort study. Cases of RAO with multiple retinal emboli were consecutively enrolled. All patients underwent at least one of the carotid/cerebral evaluations: carotid arteriography, orbital/carotid colour Doppler ultrasonography and CT angiography to demonstrate haemodynamic changes and to discuss possible mechanisms and pathways of the emboli. Among 208 RAO eyes, 12 eyes (5.7%) in 11 patients had multiple emboli were recruited in this study. Eleven eyes (91.6%) had ipsilateral carotid plaques and atherosclerosis with high-grade stenosis; among them, five were total carotid occlusion. Haemodynamic changes were found in nine patients with RAO (81.8%) with carotid stenosis 60% or greater. Most compensatory intracranial circulations were re-established via the circle of Willi with antegrade ophthalmic flows, but the direction of ophthalmic flow reversed in three eyes indicating the recruitment of external collaterals. Two cases underwent carotid stent successfully.

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Copyright © 2020 BMJ Publishing Group Ltd. All rights reserved.

Source: BMJ Open Ophthalmology. Published July 27, 2020. http://dx.doi.org/10.1136/bmjophth-2020-000467.


FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord

FDA approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

source: FDA

Summary

FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord

Second FDA Approved Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option

[Posted 19/Jun/2020]

AUDIENCE: Ophthalmology, Neurology, Internal Medicine

The U.S. Food and Drug Administration today approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Uplizna is only the second approved treatment for the disorder.

“Until recently, patients with NMOSD had no FDA-approved treatment options,” said Billy Dunn, M.D., Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Uplizna now represents the second approved therapy for these patients within the past year. We continue to remain highly committed to the development of additional safe and effective drugs for this rare and devastating disease.”

In patients with NMOSD, the body’s immune system mistakenly attacks healthy cells and proteins in the body, most often those in the optic nerves and spinal cord. Individuals with NMOSD typically have attacks of optic neuritis, which causes eye pain and vision loss. Individuals also can have attacks resulting in transverse myelitis, which often causes numbness, weakness, or paralysis of the arms and legs, along with loss of bladder and bowel control. Most attacks occur in clusters, days to months to years apart, followed by partial recovery during periods of remission. Approximately 50% of patients with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks. According to the National Institutes of Health, women are more often affected by NMOSD than men and African Americans are at greater risk of the disease than are Caucasians. Estimates vary, but NMOSD is thought to impact approximately 4,000 to 8,000 patients in the United States.

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NMOSD can be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). Binding of the anti-AQP4 antibody appears to activate other components of the immune system, causing inflammation and damage to the central nervous system.

The effectiveness of Uplizna for the treatment of NMOSD was demonstrated in a clinical study of 230 adult patients that evaluated the efficacy and safety of intravenous Uplizna. In the trial, 213 of the 230 patients had antibodies against AQP4 (anti-AQP4 antibody positive). During the 197-day study, the risk of an NMOSD relapse in the 161 anti-AQP4 antibody positive patients who were treated with Uplizna was reduced by 77% when compared to the placebo treatment group. There was no evidence of a benefit in patients who were anti-AQP4 antibody negative.

The prescribing information for Uplizna includes a warning for infusion reactions, potential depletion of certain proteins (hypogammaglobulinemia), and potential increased risk of infection – including Progressive Multifocal Leukoencephalopathy, and potential reactivation of hepatitis B and tuberculosis. The most common adverse reactions in the NMOSD clinical trial were urinary tract infection, headache, joint pain (arthralgia), nausea and back pain. Women who are pregnant should not take Uplizna because it may cause harm to a developing fetus or newborn baby. The FDA advises health care professionals to inform females of reproductive age to use effective contraception during treatment with Uplizna and for six months after the last dose. Vaccination with live-attenuated or live vaccines is not recommended during treatment and should be administered at least four weeks prior to initiation of Uplizna.

Uplinza received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted approval of Uplizna to Viela Bio.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Published: June 11, 2020.


Ranibizumab or Aflibercept for Diabetic Macular Edema

Both ranibizumab and aflibercept improved vision and decreased macular thickness in eyes with diabetic macular edema (DME) in clinical trials.

source: Ophthalmology

Summary

Ranibizumab or Aflibercept for Diabetic Macular Edema: Comparison of 1-Year Outcomes from the Fight Retinal Blindness! Registry

[Posted 23/Apr/2020]

AUDIENCE: Ophthalmology, Internal Medicine

KEY FINDINGS: Both drugs were beneficial for DME. Aflibercept-treated eyes, which had borderline worse vision and thicker maculae at baseline, showed larger CST reductions after 12 months of treatment. Larger VA gains were observed with aflibercept treatment when the initial VA was 20/50 or worse.

BACKGROUND: Both ranibizumab and aflibercept improved vision and decreased macular thickness in eyes with diabetic macular edema (DME) in clinical trials. This study compared the 12-month treatment outcomes of each drug in routine clinical practice.

DETAILS: Retrospective analysis of data from the prospectively designed observational Fight Retinal Blindness! registry. Treatment-naive eyes tracked in the registry that initiated treatment with either ranibizumab (0.5 mg) or aflibercept (2 mg) for DME from December 1, 2013, through June 1, 2018. Visual acuity (VA) was analyzed at 12 months in all eyes (completers, noncompleters, and eyes that switched treatment). The primary outcome was the mean change in VA from baseline to 12 months. We identified 383 eyes (ranibizumab, n = 166 eyes; aflibercept, n = 217 eyes) of 291 patients. Eyes receiving aflibercept showed a lower mean VA (mean difference, -3.1 letters) and a thicker maculae (mean difference, +26 μm) at baseline than those receiving ranibizumab, which were not significantly different. Patients receiving ranibizumab were older (mean difference, +2.7 years). The adjusted mean difference in VA change and central subfield thickness (CST) reduction were, respectively, +1 letter (1.4 letters for aflibercept vs. 0.4 letter for ranibizumab; P = 0.4) and -30 μm (-85 vs. -55 μm; P < 0.01) in eyes with initial VA of 20/40 or better and +3 letters (10.6 vs. 7.6 letters; P < 0.01) and -46 μm (-148 vs. -102 μm; P < 0.02) in those with VA of 20/50 or worse. Eyes in the aflibercept group received more median injections over 12 months than the ranibizumab group although this difference was not significant (8 vs. 6 injections; P = 0.13). Treatment switches, albeit low, were more frequent from ranibizumab to aflibercept than vice versa. Significantly more eyes in the aflibercept group were lost to follow-up within 12 months (21% vs. 9% ranibizumab; P < 0.01).

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Copyright © 2019 by the American Academy of Ophthalmology. All rights reserved.

Source: Ophthalmology. Published May 2020. https://doi.org/10.1016/j.ophtha.2019.11.018


VF Changes in Patients Treated with Panretinal Photocoagulation or Ranibizumab

There are factors besides PRP associated with VF loss in eyes treated for proliferative diabetic retinopathy.

source: JAMA

Summary

Visual Field Changes Over 5 Years in Patients Treated With Panretinal Photocoagulation or Ranibizumab for Proliferative Diabetic Retinopathy

[Posted 6/Feb/2020]

AUDIENCE: Ophthalmology, Internal Medicine

KEY FINDINGS: While laser treatments account for some of the VF loss over time, these data suggest that other processes may be associated with VF deterioration; however, limitations of the available data prevent more specific conclusions. The limited data available from Protocol S suggest that there are factors besides PRP associated with VF loss in eyes treated for proliferative diabetic retinopathy. Further clinical research is warranted to clarify the finding.

BACKGROUND: To further evaluate changes in VF throughout 5 years among eyes enrolled in the Protocol S clinical trial, conducted by the DRCR Retina Network. Preservation of peripheral visual field (VF) is considered an advantage for anti–vascular endothelial growth factor agents compared with panretinal photocoagulation (PRP) for treatment of proliferative diabetic retinopathy. Long-term data on VF are important when considering either treatment approach.

DETAILS: Post hoc analyses of an ancillary study within a multicenter (55 US sites) randomized clinical trial. Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included. Data were collected from February 2012 to February 2018. Analysis began in June 2018. Of 394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study. Of these, 167 (71.4%) had VF meeting acceptable quality criteria at baseline (median [interquartile range] age, 50 [43-58] years; 90 men [53.9%]). At 5 years, 79 (33.8%) had results available. The mean (SD) change in total point score in the PRP and ranibizumab groups was –305 (521) dB and –36 (486) dB at 1 year, respectively, increasing to –527 (635) dB and –330 (645) dB at 5 years, respectively (P = .04). After censoring VF results after PRP treatments in the ranibizumab group, the 5-year mean change in total point score was –201 (442) dB. In a longitudinal regression analysis of change in total point score including both treatment groups, laser treatment was associated with a mean point decrease of 208 (95% CI, 112-304) dB for the initial PRP session, 77 (95% CI, 21-132) dB for additional PRP sessions, and 325 (95% CI, 211-439) dB for endolaser. No association was found between change in point score and the number of ranibizumab injections during the previous year (–9 per injection [95% CI, –22 to 3]).

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TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01489189

Copyright © 2020 American Medical Association. All Rights Reserved.

Source: JAMA Ophthalmol. Published January 30, 2020. doi:10.1001/jamaophthalmol.2019.5939


FDA Approves First Treatment for Thyroid Eye Disease

FDA approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease.

source: FDA
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Summary

FDA Approves First Treatment for Thyroid Eye Disease

[Posted 30/Jan/2020]

AUDIENCE: Ophthalmology, Internal Medicine, Family Medicine

Today, the U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). Today’s approval represents the first drug approved for the treatment of thyroid eye disease.

“Today’s approval marks an important milestone for the treatment of thyroid eye disease. Currently, there are very limited treatment options for this potentially debilitating disease. This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non surgical treatment option,” said Wiley Chambers, M.D., deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research. “Additionally, thyroid eye disease is a rare disease that impacts a small percentage of the population, and for a variety of reasons, treatments for rare diseases are often unavailable. This approval represents important progress in the approval of effective treatments for rare diseases, such as thyroid eye disease.”

Thyroid eye disease is associated with the outward bulging of the eye that can cause a variety of symptoms such as eye pain, double vision, light sensitivity or difficulty closing the eye. This disease impacts a relatively small number of Americans, with more women than men affected. Although this condition impacts relatively few individuals, thyroid eye disease can be incapacitating. For example, the troubling ocular symptoms can lead to the progressive inability of people with thyroid eye disease to perform important daily activities, such as driving or working.

Tepezza was approved based on the results of two studies (Study 1 and 2) consisting of a total of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo. Of the patients who were administered Tepezza, 71% in Study 1 and 83% in Study 2 demonstrated a greater than 2 millimeter reduction in proptosis (eye protrusion) as compared to 20% and 10% of subjects who received placebo, respectively.

The most common adverse reactions observed in patients treated with Tepezza are muscle spasm, nausea, alopecia (hair loss), diarrhea, fatigue, hyperglycemia (high blood sugar), hearing loss, dry skin, dysgeusia (altered sense of taste) and headache. Tepezza should not be used if pregnant, and women of child-bearing potential should have their pregnancy status verified prior to beginning treatment and should be counseled on pregnancy prevention during treatment and for 6 months following the last dose of Tepezza.

The FDA granted this application Priority Review, in addition to Fast Track and Breakthrough Therapy Designation. Additionally, Tepezza received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases or conditions. Development of this product was also in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and efficacy of products for use in rare diseases or conditions.

The FDA granted the approval of Tepezza to Horizon Therapeutics Ireland DAC.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Published: January 21, 2020.

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FDA Approves First Contact Lens Indicated to Slow the Progression of Nearsightedness in Children

MiSight contact lens is indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment.

source: FDA
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Summary

FDA Approves First Contact Lens Indicated to Slow the Progression of Nearsightedness in Children

[Posted 25/Nov/2019]

AUDIENCE: Ophthalmology, Pediatric

The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens is a single use, disposable, soft contact lens that is discarded at the end of each day, and is not intended to be worn overnight.

“Today’s approval is the first FDA-approved product to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems,” said Malvina Eydelman, M.D., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.

Myopia is the most frequent cause of correctable visual impairment worldwide. Myopia occurs when the eye grows too long from front to back (axial length). Instead of focusing images on the retina, images are focused at a point in front of the retina. As a result, people with myopia have good near vision, but poor distance vision that can be corrected with glasses or contact lenses.

Myopia is common in children and tends to increase as they get older. If a person develops severe myopia as a child, they may be susceptible to other eye problems such as early cataracts or a detached retina during adulthood. The MiSight soft contact lenses are meant to be worn daily to correct nearsightedness and slow the progression of myopia in children with healthy eyes. When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina (the back of the eye). This is believed to reduce the stimulus causing the progression of myopia.

The approval of MiSight was based on data obtained from a prospective clinical trial at four clinical sites and real-world evidence. The safety and effectiveness of MiSight was studied in a three-year randomized, controlled clinical trial of 135 children ages 8 to 12 at the start of treatment who used MiSight or a conventional soft contact lens. The trial showed that for the full three-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. In addition, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup. Over the course of the trial, there were no serious ocular adverse events in either arm of the study.

Additionally, to estimate the rate of vision-threatening corneal infections (i.e., corneal ulcers) among children and adolescents who wear soft contact lenses daily, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years old from seven community eye care clinics. The results showed a rate comparable to the rate of ulcer cases among adults who wear contact lenses daily.

As part of the approval of MiSight, the sponsor is required to conduct a postmarket study of the contact lenses to further evaluate the safety and effectiveness of the product as indicated.

The FDA granted approval of MiSight to CooperVision Inc. The device was approved using the Premarket Approval (PMA) pathway. Premarket approval is the most stringent type of device marketing application required by FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Published: November 15, 2019.

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Corneal Inlay Damage After Cosmetic Laser Treatment of the Eyelid With Long-Pulsed Nd:YAG Laser

Findings suggest that a history of corneal inlay implant should be asked about prior to any long-pulsed Nd:YAG laser treatment to the periorbital skin and eyelids.

source: JAMA
null

Summary

Corneal Inlay Damage After Cosmetic Laser Treatment of the Eyelid With Long-Pulsed Nd:YAG Laser

[Posted 30/Oct/2019]

AUDIENCE: Ophthalmology, Internal Medicine

KEY FINDING: These findings suggest that laser treatment to the eyelids should be avoided and that protective eyewear or a corneal shield is recommended during facial laser treatment in all patients. Although the exact cause and effect cannot be determined from a single case, our findings suggest that a history of corneal inlay implant should be asked about prior to any long-pulsed Nd:YAG laser treatment to the periorbital skin and eyelids. Furthermore, these findings suggest that laser treatment to the eyelids should be avoided and that protective eyewear or corneal shields are recommended during cosmetic facial laser treatment in all patients.

BACKGROUND: To describe the occurrence of corneal inlay damage following treatment to the eyelids and face with an Nd:YAG laser.

DETAILS: This observational case report includes a single incident case cared for at a tertiary care center. A 58-year-old man who had undergone bilateral uncomplicated myopic laser in situ keratomileusis surgery in 2003 and corneal inlay implant in the nondominant left eye in 2013 experienced decreased visual acuity (VA) and pain in the left eye after the application of 2 passes of the Nd:YAG laser to his face and both eyelids for facial tightening. At presentation, the uncorrected VA was counting fingers OS and 20/20 OD. Slitlamp biomicroscopy showed a corneal epithelial defect overlying a deformed corneal inlay, peripheral scattered pigmentary deposits, corneal haze, and brown discoloration of the lamellar pocket of the inlay. He underwent explant of the inlay and debridement 48 hours later because of deteriorating VA and increasing corneal haze. Application of long-pulsed Nd:YAG laser at 1064 nm to the middle one-third of both upper eyelids and the periorbital region in a man with a corneal inlay implant. Corneal shields were not worn during the procedure. The peak penetration depth of this laser system is approximately 4 mm. The mean (SD) thickness of the upper eyelid in Asian eyes is 1.127 (0.238) mm. In this 58-year-old man, 3 months after the inlay explant, the intrastromal discoloration had resolved. There was still residual corneal haze, but the patient was able to achieve a best-corrected VA of 20/25 OS for distance and J3 (Snellen equivalent, 20/30) OS for near.

Copyright © 2019 American Medical Association. All Rights reserved.

Source: JAMA Pediatr Published October 17, 2019. doi:10.1001/jamaophthalmol.2019.4126

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