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Optometry news

FDA issues CRL for aflibercept 8 mg from Regeneron Pharmaceuticals

Kassi Jackson, Editor; Sydney Crago, Editor, Modern Retina; Martin David Harp, Associate Editor, Ophthalmology Times

Regenron Pharmaceuticals announced the US Food and Drug Administration has issued a Complete Response Letter (CRL) for its aflibercept 8 mg

The company stated in a release the Biologics License Application (BLA) for aflibercept 8 mg is for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). Furthermore, the company stated the CRL is “solely due to an ongoing review of inspection findings at a third-party filler.”¹

The CRL identified no issues with aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested, Regeneron said in a press release.

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The role of nutrition in myopia control

Jeffrey Anshel, OD, FAAO

Within the eyecare community, there is a predominant consensus that the cause of juvenile onset myopia—a significant worldwide public health concern—involves both genetic and environmental elements. The rise in the prevalence of myopia has been too rapid to be explained by genetic factors alone and thus suggests a substantial role of environmental influences.

However, the interaction of these 2 components to create refractive error remains speculative. It is becoming more apparent that myopia is not only a benign refractive error but also has long-term medical and visual consequences, yet little attention has been paid to the possible role of nutrition in the development and advancement of myopia.

Numerous studies have demonstrated that near work is related to myopia; however, all individuals in industrialized countries must do regular near work during childhood education, yet only a certain percentage of the population ultimately develops myopia.

There are several factors that have been explored as potential environmental contributors to myopia development, including the spectrum of exposed light, outdoor time, circadian rhythms, spatial frequency characteristics of written material, vitamin levels, dietary intake, physical activity, excessive near work, intraocular pressure, form deprivation, and binocular vision disorders.

We will review the role of nutrition and how it interacts with the expression of genes to create the conditions that might lead to the development of myopia.

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Prevent Blindness declares June 28 to July 4 Fireworks Safety Awareness Week

David Hutton, Managing Editor, Ophthalmology Times

Prevent Blindness has declared June 28 to July 4 as the third annual Fireworks Safety Awareness Week.

According to the Consumer Product Safety Commission (CPSC), fireworks caused 9 deaths and 11,500 injuries in 2021, according to its most recent fireworks injury report. The bulk of the injuries occur between mid-June and mid-July.

“Running with sparklers, getting in the way of a bottle rocket, and fiddling around with unexploded fireworks are all just accidents waiting to happen,” Griffin Jardine, MD, an ophthalmologist at John A. Moran Eye Center, said in a news release.

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TEPEZZA approved for treatment of TED in Brazil

Martin David Harp, Associate Editor, Ophthalmology Times

Horizon Therapeutics recently announced the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) has approved TEPEZZA for the treatment of thyroid eye disease (TED).

This makes TEPEZZA the first and only medicine approved for treatment of TED in Brazil, according to a press release from the company.¹

Vikram Karnani, executive vice president and president, global commercial operations and medical affairs, Horizon discussed the impact the medicine will have in Brazil in the press release.

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Cosmetic surgery of the cornea: A new type of surgery

Jorge L. Alió, MD, PhD, FEBO

Over the past 10 years, an increasing number of studies have been conducted on the topic of keratopigmentation, that is, the induced cosmetic pigmentation change in the cornea.

This cosmetic change can be done for therapeutic purposes (eg, for corneal leukomas and blind and disfigured eyes, as well as cases with traumatic aniridia or other problems that affect the eye’s quality of vision).

The topic has been extensively studied and covered in a series of papers that have demonstrated that such techniques are effective, feasible, and very useful for patients.^1-16

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Visgenx announces positive results from key translational study for its gene therapy candidate for dry AMD

David Hutton, Managing Editor, Ophthalmology Times; Sydney Crago, Editor, Modern Retina

Visgenx, Inc. announced positive data from a non-human primate study of VGX-0111 to deliver the ELOVL2 transgene. The study used a single subretinal injection with the goal of investigating whether VGX-0111 expresses in the target tissues and causes an increase in very long chain polyunsaturated fatty acids at a dose that is well tolerated. VGX-0111 was able to successfully demonstrate these parameters.

While the underlying cause of dry age-related macular degeneration (AMD) remains unknown, recent studies point to a decline in the biosynthesis of certain long chain and very long chain polyunsaturated fatty acids (LC and VLC PUFA) plays an important underlying role. The ELOVL2 enzyme plays a central role in the biosynthesis of LC and VLC PUFAs. During aging, expression of the ELOVL2 gene declines leading to a reduction in the LC and VLC PUFAs necessary for vision. VGX-0111 is an experimental gene therapy intended to increase expression of ELOVL2. It is thought that restoring physiological ELOVL2 expression will increase levels of LC and VLC PUFAs in the retina and slow or halt the progression of dry AMD.

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AOA Optometry's Meeting 2023

Optometry Times®' editorial team was on the ground in Washington, DC., bringing you the most up-to-date coverage from the 2023 American Optometric Association Optometry's Meeting.

See the coverage...