Glossary

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A

Age-related macular degeneration (AMD)

Age-related macular degeneration (AMD) is a progressively degenerative retinal disease that affects the elderly population and that can lead to severe visual loss and legal blindness. This injury to the macula in the center of the retina can impair the ability to see straight ahead clearly and make it difficult to read, drive, or perform other daily activities that require fine central vision. 

There are two main types of AMD:

• Neovascular (also known as wet or exudative AMD)
• Non-neovascular (also known as dry or atrophic AMD)

Non-neovascular AMD is the most common form of the disease (accounting for ~90% of cases) and is characterized by the presence of drusen (tiny accumulations of extracellular material) and deterioration (atrophy) of photoreceptors, retinal pigment epithelium (RPE) and choriocapillaris (capillaries forming the inner vascular layer of the choroid of the eye) in the macular area.

B

BCBSA: Blue Cross Blue Shield Association

The Blue Cross and Blue Shield Association is a national federation of 36 independent, community-based and locally operated Blue Cross® and Blue Shield® companies. The Association owns and manages the Blue Cross and Blue Shield trademarks and names in more than 170 countries and territories around the world.  The Association grants licenses to independent companies to use the trademarks and names in exclusive geographic areas.

BLA: Biologics license application

A submission to the FDA that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and medical affects of a biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market       the product. The BLA supersedes the Product License Application for biologics.

D

DME: Diabetic Macular Edema

Diabetic macular edema (DME) – the leading cause of blindness in individuals with diabetes – is a manifestation of diabetic retinopathy that occurs when fluid leaks into the macula, causing it to thicken, and leading to blurring of vision. DME is also associated with the formation of lipoprotein deposits, called hard exudates, in the outer retinal layers.

DR: Diabetic Retinopathy

One of the most common complications of diabetes that affects the eyes, diabetic retinopathy is a chronic, progressive, sight-threatening disorder of the retinal microvasculature. DR eventually develops to some degree in nearly all patients with chronic diabetes mellitus (type 1 or type 2). In affected individuals, blood vessels become more permeable and allow fluid to leak out into the surrounding tissue. Small swellings called microaneurysms may also form in capillaries, which may break and allow blood to leak into the retinal tissue. In severe cases of diabetic retinopathy, known as proliferative diabetic retinopathy (PDR), the blood vessels are so damaged that they become completely blocked. In response, new blood vessels start to grow in the retina. These new vessels are weak and can leak blood and lead to scar tissue formation.

E

EMA: European Medicines Agency

The official agency tasked with the evaluation of medicinal products in the European Union. From 1995 to 2004, the EMA was known as European Agency for the Evaluation of Medicinal Products (EMEA).

EMEA

European Agency for Evaluation of Medicinal Products.

EPC: Evidence-based Practice Center

Under the Evidence-based Practice Centers (EPC) Program of the Agency for Healthcare Research and Quality, 5-year contracts are awarded to institutions in the United States and Canada to serve as EPCs. The EPCs review all relevant scientific literature on a wide spectrum of clinical and health services topics to produce various types of evidence reports. These reports may be used for informing and developing coverage decisions, quality measures, educational materials and tools, clinical practice guidelines and research agendas. The EPCs also conduct research on methodology of evidence synthesis.

ERM: Epiretinal membrane

An epiretinal membrane, also called macular pucker, is a fibrocellular tissue found on the inner surface of the retina. The formation of epiretinal membranes, a wound healing process, is a serious complication of retinal diseases, the most important being proliferative diabetic retinopathy (PDR) and proliferative vitreoretinopathy (PVR).

F

FDA: Food and Drug Administration

A federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

FTMH: Full-Thickness Macular Hole

A macular hole is a small break in the macula, located in the center of the eye’s light-sensitive tissue called the retina. The macula provides the sharp, central vision we need for reading, driving and seeing fine detail.

A macular hole can cause blurred and distorted central vision. Macular holes are related to aging and usually occur in people over the age of 60.

There are four stages to a macular hole:

• Foveal detachments (Stage I). Without treatment, about half of Stage I macular holes will progress.
• Partial-thickness holes (Stage II). Without treatment, about 70 per cent of Stage II macular holes will progress.
• Full-thickness holes (Stage III) with premacular vitreous still attached and no Weiss ring present.
• Full-thickness holes (Stage IV) with premacular vitreous fully detached and a Weiss ring present.

The size of the hole and its location on the retina determine how much it will affect a person’s vision. When a Stage III macular hole develops, most central and detailed vision can be lost. If left untreated, a macular hole can lead to a detached retina, a sight-threatening condition that should receive immediate medical attention.

I

ICD-9-CM: International Classification of Diseases, 9th edition, Clinical Modification

The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) is based on the World Health Organization's Ninth Revision, International Classification of Diseases (ICD-9). ICD-9-CM is the official system of assigning codes to diagnoses and procedures associated with hospital utilization in the United States. The ICD-9 was used to code and classify mortality data from death certificates until 1999, when use of ICD-10 for mortality coding started.

The ICD-9-CM consists of:

• a numerical list of the disease code numbers in tabular form;
• an alphabetical index to the disease entries; and
• a classification system for surgical, diagnostic and therapeutic procedures (alphabetic index and tabular list).

M

Metamorphopsia: Distorted vision

A type of distorted vision in which a grid of straight lines appears wavy and parts of the grid may appear blank. People with this condition often first notice this when looking at mini-blinds in their home. 

MIVI: Microplasmin for vitreous injection

The MIVI-TRUST (TG-MV-006/007) Trials. Two multicenter, randomized, double-blind, phase 3 clinical trials to compare a single intravitreal injection of ocriplasmin (125 μg) with a placebo injection in patients with symptomatic vitreomacular adhesion. The primary endpoint was resolution of vitreomacular adhesion at day 28. Secondary endpoints were total posterior vitreous detachment and nonsurgical closure of a macular hole at 28 days, avoidance of vitrectomy and change in best-corrected visual acuity.

O

OASIS: Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion including Macular Hole

A randomized, sham-controlled, double-masked study, assessing the efficacy and safety of a JETREA® in a 24-month period post-injection.

Ocriplasmin

Formerly known as microplasmin, marketed as JETREA®

OCT: Optical Coherence Tomography

An emerging technology for performing high-resolution, cross-sectional imaging. OCT is analogous to ultrasound imaging, except that it uses light instead of sound. OCT can provide cross-sectional images of tissue structure on the micron scale in situ and in real time.

ORBIT: Ocriplasmin Research to Better Inform Treatment

A large, multicenter, prospective observational study assessing the clinical outcomes and safety of patients receiving JETREA in a real-world setting for the treatment of symptomatic VMA/VMT following standard of care from US retina clinics.

OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study

A retrospective US patient study designed to capture more data to characterize the anatomic and symptomatic changes that potentially occur in the six months immediately after treatment with JETREA® for symptomatic VMA.

P

PVD: Posterior Vitreous Detachment

A normal, age-related process, which is characterized by the separation of the posterior vitreous from the retinal inner limiting membrane (ILM).

R

R&D: Research & Development

Investigative activities that a business chooses to conduct with the intention of making a discovery that can either lead to the development of new products or procedures, or to improvement of existing products or procedures.

Retinal Vein Occlusion

Retinal vein occlusion (RVO) describes the narrowing or blockage of a retinal vein. In general, RVO manifests itself with variable degrees of visual loss with any combination of fundal findings, consisting of retinal vascular tortuosity, retinal hemorrhages, cotton wool spots, optic disc swelling and macular edema.

S

sVMA: Symptomatic Vitreomacular Adhesion

Vitreomacular adhesion (VMA), where the vitreous adheres to the retina’s macular region in an abnormally strong manner, occurs as a result of pathologic posterior vitreous detachment (PVD). VMA is an asymptomatic condition. If VMA does become symptomatic, it is called symptomatic vitreomacular adhesion (sVMA). Symptoms include reduced vision, metamorphopsia, micropsia, scotoma and difficulties with daily vision-related tasks, like reading. If the forces of attachment are unusually strong, VMA can cause anatomical disturbances to the macular architecture, creating pulling forces or ‘traction’ on the retinal surface and potentially leading to the formation of a macular hole. 

V

VA: Visual Acuity

Sharpness of vision, measured by the ability to discern letters or numbers at a given distance, according to a fixed standard.

VEGF: Vascular Endothelial Growth Factor

A protein that is a major factor in promoting the growth of new blood vessels.

Vitreo-retinal Interface

The site of attachment between the posterior (rear) vitreous cortex and the inner limiting membrane of the retina.

VMA: Vitreomacular adhesion

Vitreomacular adhesion (VMA) occurs when there is incomplete posterior vitreous detachment, also referred to as anomalous posterior vitreous detachment (PVD). It is characterized by an incomplete PVD, with areas of adhesion remaining between the posterior vitreous cortex and the macula.

VMT: Vitreomacular traction

Vitreomacular traction (VMT) also occurs along the spectrum during the course of an incomplete posterior vitreous detachment, also referred to as anomalous posterior vitreous detachment (PVD). VMT is a progression of VMA when there are pulling forces localized at the site of the adhesion, leading to deleterious effects on the retina and the surrounding sites.