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Regeneron Shares Fall After FDA Rejects High-dose Eye Disease Treatment
A view of the Regeneron Pharmaceuticals headquarters in Tarrytown, New York.
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Shares of Regeneron fell nearly 9% Tuesday after the U.S. Food and Drug Administration declined to approve a higher-dose version of the company's blockbuster eye disease treatment.
The company was seeking approval for an 8-milligram dose of its injection, Eylea, for patients with wet age-related macular degeneration — the leading cause of blindness among the elderly — and two other eye diseases that are common in people with diabetes.
Regeneron said the rejection was "solely due to an ongoing review of inspection findings at a third-party filler."
The company did not provide further details on those findings or identify the third party, but said the decision was not related to the drug's efficacy, safety, trial design, labeling or drug substance manufacturing.
That suggests the drug could potentially win approval down the road.
But a delay won't help the company fight off threats to its Eylea drug franchise, which is facing competition from Roche Holdings' eye drug, Vabysmo. Roche's treatment was approved last year.
Regeneron stock fell nearly 9% Tuesday after an FDA rejection of a higher-dose version of the company's blockbuster eye treatment.
Age-related Macular Degeneration (AMD): New Mini Telescope May Improve Vision
It is estimated that about 20 million people in the United States have some form of age-related macular degeneration (AMD), a condition that causes central vision loss.
Previous research has demonstrated that an implantable miniature telescope (IMT) consisting of specialized lenses that serve as a tiny telescope in the affected eye can help reduce AMD-associated deficits in central vision.
This first-generation implant has been described as cost-effective and compatible with other procedures such as cataract surgery. It has been approved for use in individuals aged 65 years and older with advanced AMD.
A second generation of this prosthetic developed by Samsara Vision, Inc., called the smaller-incision new-generation implantable miniature telescope (SING IMT), is designed to reduce the complexity of the surgical process, improve safety, and increase the speed of recovery.
A recent three-month study suggests that the SING-IMT is safe and improves distance and near visual in people with advanced AMD as well as resulting in lower levels of surgical trauma than its predecessor.
SING-IMT has not yet been approved by the Food and Drug Administration (FDA).
Dr. Edward Wood, a vitreoretinal surgeon with Austin Retina Associates in Texas who was not involved in the study, said the new technology shows promise.
"[This study evaluating the impact of the SING IMT showed] that at postoperative month three, 70.83% of patients gained ≥ 2 lines of visual acuity on the eye chart, 58.33% gained ≥ 3 lines, and 25.00% gained ≥ 4 lines of corrected distance visual acuity. Near visual acuity improved as well," Wood told Medical News Today.
"Postoperative changes to the cornea (including changes to the endothelial cell layer) were comparable to those seen in modern cataract surgery. Overall, this trial showed that the SING IMT appeared to be safe and effective as a low-vision rehabilitation aid in patients with moderate to profound vision loss due to advanced AMD."
— Dr. Edward Wood, vitreoretinal surgeon
The retina is the innermost layer of the eye, made up of photoreceptors that convert light into nerve impulses.
The macula is the central part of the retina and is involved in sharp, straight vision, also known as central vision.
The damage to the cells in the macula, known as macular degeneration, causes a gradual loss of central vision, impairing the ability to view fine details.
Age-related macular degeneration is the leading cause of vision loss in older adults.
AMD hinders the performance of daily activities, such as reading and driving, and is associated with a decline in quality of life.
Wet vs. Dry AMDAMD can be categorized as either wet or dry AMD.
Wet AMD is caused by leakage of blood vessels associated with the retina, whereas dry AMD involves damage to photoreceptors in the macula associated with the build-up of deposits called drusen.
While therapeutics are available for the treatment of early-stage AMD, there is a lack of interventions for people with advanced AMD.
There are also ongoing efforts to develop interventions to regenerate the cells in the macula that are lost due to macular degeneration. However, these interventions are still in the clinical trial phase and are years away from clinical use.
Currently, nonsurgical options for individuals with AMD include spectacles and magnifiers. However, using these aids requires individuals with AMD to get accustomed to hand or head movements to scan the visual field.
An alternative to these optical aids includes surgery to implant optics that are more intuitive to use and can attenuate the deficits in vision associated with AMD.
One such technology is the implantable miniaturized telescope (IMT), which uses a combination of lenses that function as a tiny Galilean telescope.
This implantable telescope consists of an objective biconvex lens that converges light rays from the object to form an image and another biconcave lens called the eyepiece that projects this image to the eye. These lenses are sealed to prevent exposure to fluids in the eye.
This miniaturized telescope helps to project light to the healthier regions of the retina and form a 2.2 to 2.7 times magnified image of the central visual field.
The other unoperated eye provides information about the peripheral visual field.
The first-generation IMT required an incision of 10-12 mm for implantation.
A clinical trial showed that the first-generation IMT prosthetics improved visual acuity in 90% of operated eyes. After the placement of the IMT prosthetic, patients are required to undergo a few months of postoperative rehabilitation to prevent double vision and help them get accustomed to using the prosthetic.
The second generation of this prosthetic, the smaller-incision new-generation implantable miniature telescope (SING IMT), was developed to reduce surgical complexity and improve safety while retaining the same magnification as its predecessor.
Specifically, the implantation of the SING IMT requires fewer sutures and a smaller incision of 6-8 mm. The ease of implantation and reduced surgical complexity can reduce trauma during surgery and the recovery time after the operation.
"The smaller incision next-generation implantable miniature telescope (SING IMT) is a special lens that goes inside the eye to improve the visual experience for patients with bilateral moderate to profound central vision impairment due to advanced age-related macular degeneration. The patient undergoes cataract surgery followed by implantation of a special implantable miniature telescope (IMT) lens instead of one of the more commonly used intraocular lenses (IOLs)."
— Dr. Edward Wood, vitreoretinal surgeon
"It does not alone improve the health of the eye, but it is a sophisticated example of a low vision aid that is placed inside the eye, minimizing the burden of using other low vision aids," Dr. Wood explained.
"The SING IMT is the second generation lens of its kind, with improvements including smaller size and subsequently more efficient surgery."
The recent three-month study was done with people with moderate to advanced AMD in both eyes.
Researchers said it showed that the implantation of SING IMT prosthetic significantly improved far and near-visual acuity in the operated eye compared with before surgery.
Moreover, the study found that the damage caused to the inner layer of the cornea during the implantation of SING IMT was less severe than that due to the first-generation prosthetic.
This suggests that SING IMT may indeed reduce trauma during surgery, presumably due to the fewer sutures needed during surgery.
Macular Degeneration Treatment Market Size Is Projected To Reach USD 15.16 Billion By 2030, Growing At A CAGR Of 7.06%: Straits Research
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The global macular degeneration treatment market size was valued at USD 8,208.70 million in 2021. It is expected to reach USD 15,167.69 million by 2030, growing at a CAGR of 7.06% during the forecast period (2022–2030), The wet age-related macular degeneration segment is the highest contributor to the market and is expected to grow at a CAGR of 6.98% over the forecast period.
New York, United States, June 19, 2023 (GLOBE NEWSWIRE) -- The eye's macula is impacted by macular degeneration, a neurodegenerative condition. Macular degeneration will cause loss of central vision because it gives the clear main idea required to see objects. It manifests when the capillaries close to the fovea enlarge and leak. The fluid buildup interferes with light reflection, which causes progressive vision loss. Nutritional therapy can aid treatment in the early stages of dry macular degeneration. A healthy diet rich in antioxidants is part of the plan to sustain the macula's cells.
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Rising Impact of Retinal Disorder Drivers on the Global Market
The rising prevalence of retinal diseases has increased the demand for macular degeneration treatment. Eye conditions have emerged as potential threats in many developed and developing countries. Globally, the prevalence of the most severe eye conditions is rising, and vision loss is becoming a serious public health concern. Numerous worldwide retinal diseases that impair vision have been identified by the World Health Organization (WHO). Two of these conditions, refractive errors, and age-related macular disorders, are most prevalent in underdeveloped countries. As a result of the rising prevalence of retinal disorders, it is anticipated that the market for treating macular degeneration will expand significantly over the forecast period.
Rapid Aging Population Creates Tremendous Opportunities
According to the UN's World Aging Report, 703 million individuals were 65 or older in 2019. By 2050, this number is anticipated to double. The population aged 65 and older increased globally from 6% in 1990 to 9% in 2019. Smart contact lenses and intelligent optometry are two examples of cutting-edge and digital healthcare products that may impact the market under consideration. Future developments in digital technology could affect eye care. Future access to gene chips could lead to more accurate AMD and glaucoma diagnosis and treatment. Due to investments made by businesses and accelerated research, the market is anticipated to grow during the forecast period.
Story continues
Report Scope
Report Metric
Details
Market Size by 2030
USD 15,167.69 million
Market Size in 2021
USD 8,208.70 million
CAGR
7.06% (2022-2030)
Historical Data
2019-2020
Base Year
2021
Forecast Period
2022-2030
Forecast Units
Value (USD Million)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
Type, Stage of Disease, Route of Administration, Sales Channels
Geographies Covered
North America, Europe, Asia-Pacific, LAME and Rest of the World
Key Companies Profiled/Vendors
Novartis AG, Pfizer Inc., Panoptica, Bausch Health Companies Inc., Regeneron Pharmaceutical Inc., Aerie Pharmaceutical Inc., REGENXBIO Inc., and Bayer AG
Key Market Opportunities
Rapid Aging Population
Key Market Drivers
Rising Impact of Retinal DisordersImproving Investments in Research and Development
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Regional Analysis
North America is the most significant shareholder in the global macular degeneration treatment market and is expected to grow at a CAGR of 7.10% during the forecast period. The United States represents a sizable portion of the market under study due to several factors, including the burden of the aging population and the prevalence of age-related macular degeneration. The US is dedicated to improving overall population eye health through several initiatives. Along with recent product launches and established healthcare infrastructure, it is also anticipated that the presence of the major market players will hasten the market's expansion in the United States. Novel macular degeneration treatments are expected to fuel market growth in the United States.
Europe is expected to grow at a CAGR of 6.70%, generating USD 3,531.14 million during the forecast period. The aging population, the rising prevalence of macular degeneration, and sizable R&D expenditures are additional factors influencing the expansion of the French market under investigation. In France, there are an increasing number of cutting-edge research studies being carried out. The funding provided by the government, both at the national and EU agency levels, is primarily to blame. Medical costs are covered by the government and the individual in France, which has one of the best healthcare systems. Over the anticipated period, it is anticipated that these campaigns will increase public awareness and spur rapid market growth in France.
The presence of significant market players, the rising elderly population in Japan, and the rising awareness of macular degeneration in Asia-Pacific all point to a substantial expansion of the Japanese market for macular degeneration treatments. Japan is one of the Asian countries that is aging quickly. In June 2019, Sumitomo Dainippon Pharma Co. Ltd. Modified its contract with Healios K.K. For joint development initiatives and other cooperative activities in Japan. The modifications concerned the activities of development and commercialization. Joint development activities will generate retinal pigment epithelial cells from iPS cells to treat age-related macular degeneration and other eye diseases. Due to the rising AMD prevalence and research and development efforts in the area, the market for macular degeneration treatments in Japan is anticipated to increase.
Key Highlights
The global macular degeneration treatment market size was valued at USD 8,208.70 million in 2021. It is expected to reach USD 15,167.69 million by 2030, growing at a CAGR of 7.06% during the forecast period (2022–2030).
Based on type, the global macular degeneration treatment market is bifurcated into dry and wet age-related macular degeneration. The wet age-related macular degeneration segment is the highest contributor to the market and is expected to grow at a CAGR of 6.98% over the forecast period.
Based on the stage of disease, the global macular degeneration treatment market is bifurcated into early-stage AMD, intermediate AMD, and late-stage AMD. The late-stage AMD segment owns the highest market share and is expected to grow at a CAGR of 7.03% during the forecast period.
Based on the route of administration, the global macular degeneration treatment market is bifurcated into the intravenous route and intravitreal route. The intravitreal route segment is the highest contributor to the market and is expected to grow at a CAGR of 7.10% during the forecast period.
Based on sales channels, the global macular degeneration treatment market is bifurcated into ambulatory surgical centers and hospitals. The hospital segment owns the highest market share and is expected to grow at a CAGR of 7.04% during the forecast period.
North America is the most significant shareholder in the global macular degeneration treatment market and is expected to grow at a CAGR of 7.10% during the forecast period.
Competitors in Macular Degeneration Treatment Market
Novartis AG
Pfizer Inc.
Panoptica
Bausch Health Companies Inc.
Regeneron Pharmaceutical Inc.
Aerie Pharmaceutical Inc.
REGENXBIO Inc.
Bayer AG
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Segmentation of Macular Degeneration Treatment Market
By Type
By Stage of Disease
Early-stage AMD
Intermediate AMD
Late-stage AMD
By Route of Administration
Intravenous Route
Intravitreal Route
By Sales Channels
By Regions
TABLE OF CONTENT
Executive Summary
Research Scope & Segmentation
Research Objectives
Market Definition
Limitations & Assumptions
Market Scope & Segmentation
Currency & Pricing Considered
Market Opportunity Assessment
Emerging Regions / Countries
Emerging Companies
Emerging Applications / End Use
Investment Landscape
New Business Models / Revenue Streams
TAM
Market Trends
Drivers
Market Warning Factors
Latest Macro Economic Indicators
Geopolitical Impact
Human Factors
Technology Factors
Market Assessment
Porters Five Forces Analysis
Value Chain Analysis
Sales And Distribution Channel Analysis
Case Study Analysis
Patent Analysis
M & A Agreements & Collabration Analysis
ESG TRENDS
Global Macular Degeneration Treatment Market Size Analysis
Global Macular Degeneration Treatment Market Introduction
By Type
Introduction
Type By Value
Dry Age-Related Macular Degeneration
By Value
Wet Age-Related Macular Degeneration
By Value
By Stage Of Disease
Introduction
Stage Of Disease By Value
Early-Stage AMD
By Value
Intermediate AMD
By Value
Late-Stage AMD
By Value
By Route Of Administration
Introduction
Route Of Administration By Value
Intravenous Route
By Value
Intravitreal Route
By Value
By Sales Channels
Introduction
Sales Channels By Value
Ambulatory Surgical Centers
By Value
Hospitals
By Value
Other Sales Channels
By Value
North America Market Analysis
Introduction
By Type
Introduction
Type By Value
Dry Age-Related Macular Degeneration
By Value
Wet Age-Related Macular Degeneration
By Value
By Stage Of Disease
Introduction
Stage Of Disease By Value
Early-Stage AMD
By Value
Intermediate AMD
By Value
Late-Stage AMD
By Value
By Route Of Administration
Introduction
Route Of Administration By Value
Intravenous Route
By Value
Intravitreal Route
By Value
By Sales Channels
Introduction
Sales Channels By Value
Ambulatory Surgical Centers
By Value
Hospitals
By Value
Other Sales Channels
By Value
U.S.
Canada
Europe Market Analysis
Introduction
By Type
Introduction
Type By Value
Dry Age-Related Macular Degeneration
By Value
Wet Age-Related Macular Degeneration
By Value
By Stage Of Disease
Introduction
Stage Of Disease By Value
Early-Stage AMD
By Value
Intermediate AMD
By Value
Late-Stage AMD
By Value
By Route Of Administration
Introduction
Route Of Administration By Value
Intravenous Route
By Value
Intravitreal Route
By Value
By Sales Channels
Introduction
Sales Channels By Value
Ambulatory Surgical Centers
By Value
Hospitals
By Value
Other Sales Channels
By Value
U.K.
Germany
France
Spain
Italy
Russia
Nordic
Benelux
Rest Of Europe
APAC Market Analysis
Introduction
By Type
Introduction
Type By Value
Dry Age-Related Macular Degeneration
By Value
Wet Age-Related Macular Degeneration
By Value
By Stage Of Disease
Introduction
Stage Of Disease By Value
Early-Stage AMD
By Value
Intermediate AMD
By Value
Late-Stage AMD
By Value
By Route Of Administration
Introduction
Route Of Administration By Value
Intravenous Route
By Value
Intravitreal Route
By Value
By Sales Channels
Introduction
Sales Channels By Value
Ambulatory Surgical Centers
By Value
Hospitals
By Value
Other Sales Channels
By Value
China
Korea
Japan
India
Australia
Taiwan
South East Asia
Rest Of Asia-Pacific
Middle East And Africa Market Analysis
Introduction
By Type
Introduction
Type By Value
Dry Age-Related Macular Degeneration
By Value
Wet Age-Related Macular Degeneration
By Value
By Stage Of Disease
Introduction
Stage Of Disease By Value
Early-Stage AMD
By Value
Intermediate AMD
By Value
Late-Stage AMD
By Value
By Route Of Administration
Introduction
Route Of Administration By Value
Intravenous Route
By Value
Intravitreal Route
By Value
By Sales Channels
Introduction
Sales Channels By Value
Ambulatory Surgical Centers
By Value
Hospitals
By Value
Other Sales Channels
By Value
UAE
Turkey
Saudi Arabia
South Africa
Egypt
Nigeria
Rest Of MEA
LATAM Market Analysis
Introduction
By Type
Introduction
Type By Value
Dry Age-Related Macular Degeneration
By Value
Wet Age-Related Macular Degeneration
By Value
By Stage Of Disease
Introduction
Stage Of Disease By Value
Early-Stage AMD
By Value
Intermediate AMD
By Value
Late-Stage AMD
By Value
By Route Of Administration
Introduction
Route Of Administration By Value
Intravenous Route
By Value
Intravitreal Route
By Value
By Sales Channels
Introduction
Sales Channels By Value
Ambulatory Surgical Centers
By Value
Hospitals
By Value
Other Sales Channels
By Value
Brazil
Mexico
Argentina
Chile
Colombia
Rest Of LATAM
Competitive Assessment
Adoption Matrix
Macular Degeneration Treatment Market Share By Manufacturers
Macular Degeneration Treatment Market Ranking By Revenue For Manufacturers
Average Price By Manufacturers
Vendor Footprint Analysis
Market Players Assessment
Novartis AG
Overview
Business Information
Revenue
ASP
Gross Margin
Swot Analysis
Recent Developmments
Pfizer Inc.
Panoptica
Bausch Health Companies Inc.
Regeneron Pharmaceutical Inc.
Aerie Pharmaceutical Inc.
REGENXBIO Inc.
Bayer AG.
Research Methodology
Research Data
Secondary Data
Major Secondary Sources
Key Data From Secondary Sources
Primary Data
Key Data From Primary Sources
Breakdown Of Primaries
Secondary And Primary Research
Key Industry Insights
Market Size Estimation
Bottom-Up Approach
Top-Down Approach
Market Projection
Research Assumptions
Assumptions
Limitations
Risk Assessment
APPENDIX
Discussion Guide
Customization Options
Related Reports
DISCLAIMER
Table of Content and Figure @ https://straitsresearch.Com/report/macular-degeneration-treatment-market/toc
Recent Development
In August 2022, Novartis intends to completely spin off the Sandoz division to establish a standalone business.
In September 2022, Bayer will present new cardiorenal results for Kerendia in individuals with early-stage chronic kidney disease and type 2 diabetes (finerenone).
News Media
Global Macular Degeneration Treatment Market Ascends at a Noteworthy CAGR of 7.06%
Global Lacrimal Devices Market to Grow at a CAGR of 3.5%
Posterior Segment Eye Disorders Market Share Extends at a Healthy CAGR of 4.83% by 2031
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