PUBLISHER: DelveInsight | PRODUCT CODE: 1705104
PUBLISHER: DelveInsight | PRODUCT CODE: 1705104
DelveInsight's "Bullous Keratopathy Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of bullous keratopathy, historical and forecasted epidemiology, as well as the bullous keratopathy market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The Bullous Keratopathy Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM bullous keratopathy market size from 2020 to 2034. The report also covers bullous keratopathy treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Bullous Keratopathy Treatment Market: Understanding and Algorithm
The term keratopathy comes from the root words Kera, meaning cornea, and pathy, meaning disease; therefore, keratopathy is the disease of the cornea with a vast array of underlying causes and mechanisms. Keratopathy can occur due to an eye condition or systemic conditions. There are several types of keratopathy, including bullous keratopathy. Bullous keratopathy is a pathological condition in which small vesicles, or bullae, formation occurs in the cornea due to endothelial dysfunction. Initially, there is endothelial trauma, followed by progressive stromal and epithelial edema. The epithelial edema results in the formation of bullae, hence the name bullous keratopathy.
Bullous keratopathy is also called pseudophakic bullous keratopathy (PBK) or pseudophakic corneal edema (PCE) in certain cases because it specifically occurs in individuals who have undergone cataract surgery and have had an IOL implanted in their eye. The main characterization is the formation of fluid-filled blisters or bullae on the cornea, which can cause pain, blurred vision, and other visual disturbances. This condition typically occurs due to damage to the corneal endothelium, the innermost layer of cells that maintains the cornea's clarity and controls fluid balance.
Bullous keratopathy diagnosis
Diagnosis of bullous keratopathy typically involves a comprehensive eye examination, including visual acuity testing, slit-lamp examination, and evaluation of corneal thickness and clarity. In some cases, additional tests such as corneal topography or specular microscopy are required to assess the severity and extent of corneal damage.
Bullous keratopathy Treatment
The treatment options for bullous keratopathy depend on the underlying cause and the severity of the condition. In the early stages, conservative measures to manage symptoms, such as lubricating eye drops, hyperosmotic agents, anti-glaucoma medications, steroids, ointments, or bandage contact lenses, are used to relieve pain and protect the cornea. The approval of allogeneic cell therapy in Japan may prove to be effective. However, if the condition progresses and significantly affects vision and quality of life, surgical intervention may be necessary.
Corneal transplantation, specifically endothelial keratoplasty (EK) procedures like Descemet's stripping automated endothelial keratoplasty (DSAEK) or Descemet's membrane endothelial keratoplasty (DMEK), is a common surgical option for bullous keratopathy. These procedures involve replacing the damaged corneal endothelium with healthy donor tissue to restore corneal clarity and improve visual function.
As the market is derived using a patient-based model, the bullous keratopathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total cases of major etiologies of bullous keratopathy, total cases of bullous keratopathy in major etiologies, total diagnosed prevalent cases of bullous keratopathy , gender-specific diagnosed prevalent cases of bullous keratopathy, total cases of bullous keratopathy in corneal transplant/keratoplasty in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the Bullous Keratopathy therapeutics market report encloses a detailed analysis of bullous keratopathy-marketed drugs and mid to late-stage (Phase III and Phase II) Bullous Keratopathy pipeline drugs analysis. It also helps understand the bullous keratopathy clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest Bullous Keratopathy news and press releases.
Bullous Keratopathy Marketed Drugs
VYZNOVA, developed by Aurion Biotechnologies, is a cell therapy indicated for treating bullous keratopathy of the cornea in Japan. VYZNOVA consists of allogeneic human corneal endothelial cells, referred to as "neltependocel", and Y-27632, a small molecule drug that inhibits Rho-associated, coiled-coil containing protein kinase. This combination facilitates the regeneration of fully differentiated corneal endothelial cells (CECs) outside the body. Donor corneal cells undergo a proprietary, multi-step process to create off-the-shelf allogeneic CECs. These cells are injected into the eye, where they form a healthy mono-layer and reduce corneal edema by removing excess fluid.
In March 2023, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) approved VYZNOVA to treat bullous keratopathy of the cornea.
Bullous Keratopathy Emerging Drugs
TTHX1114 (NM141) is an engineered form of fibroblast growth factor-1 protein (FGF-1). The native FGF-1 is a potent stimulator of cell proliferation and migration and has cell-protective properties. The compound uniquely activates all seven forms of the FGF receptor, contributing to its potency; however, the naturally occurring FGF-1 molecule has an extremely short half-life. The engineered FGF-1, TTHX1114, is designed to increase the half-life of the FGF-1 molecule and stimulate the proliferation and migration of corneal endothelial cells.
TTHX1114 is intended to restore vision in patients with corneal endothelial diseases, including pseudophakic bullous keratopathy. It is being developed as an intracameral injection, which involves injecting a small amount of TTHX1114 into the anterior chamber of the eye (directly behind the cornea) using a very small needle.
In April 2023, Trefoil Therapeutics presented Phase II results for TTHX1114 in patients with Fuchs endothelial corneal dystrophy (FECD) undergoing Descemet's Stripping Only (DSO) in combination with cataract surgery at the Annual Association for Research in Vision and Ophthalmology (ARVO) Meeting.
EO2002 is a first-in-class, non-surgical, magnetic cell-based therapy that can modify disease, developed through an exclusive magnetic cell delivery (MCD) nanoparticle platform. The MCD platform facilitates the delivery, retention, and integration of cell therapies by leveraging magnetic nanoparticles to effectively localize and integrate cell therapies to the appropriate target tissue.
In April 2024, Emmecell completed the final dose administration for the last patient in the US randomized, double-masked, multi-center Phase I trial assessing the safety and efficacy of EO2002 for treating corneal edema. Topline results are expected in the second half of 2024, with a Phase III pivotal study planned for the first quarter of 2025.
Bullous Keratopathy Drugs Market Insights
The current Bullous Keratopathy treatment market landscape involves both pharmacological and surgical therapies. Medicinal interventions such as cell therapy, hypertonic saline drops and ointment (sodium chloride 5%), antibiotics, anti-inflammatories, antiglaucoma, lubricating drops, and other medications are used for symptomatic relief. However, medical management is only favorable in the early stages of the disease, and when it fails, surgery is considered.
Cornea transplant remains the gold standard of treatment for bullous keratopathy, which requires the replacement of damaged endothelium with a healthy endothelium from a donor to restore the normal structure and function of endothelial cells; however, visual recovery takes some time. The graft size is usually 7-7.5 mm to avoid complications of small and large grafts, such as astigmatism and secondary glaucoma.
Hydrophilic contact lenses are widely used to decrease pain associated with epithelial bullae; however, they do not reduce the amount of edema. The contact lenses can be used with 5% hypertonic saline to improve visual acuity by decreasing epithelial and stromal edema. Usually, the pain associated with PBK arises from the rupture of bullae with exposure of corneal nerves endings or swelling of epithelium leading to stretching of nerve endings, and the lenses alleviate pain as long as the lens remains in place by acting as an effective precorneal protective layer.
The approval of the first allogenic cell therapy globally marked a significant advancement in the treatment of corneal endothelial disease. In March 2023, PMDA approved VYZNOVA for treating bullous keratopathy of the cornea. The therapy addresses the need for non-surgical intervention and overcomes the donor cornea shortage by treating more than 100 eyes with fully differentiated CECs from a single donor. Healthy cells from a donor cornea are cultured in a novel, multi-step, proprietary, and patented process that produces off-the-shelf, allogeneic, fully differentiated CEC. Further, the endothelial cells are administrated intracamerally, where a repopulation of cells into a healthy monolayer occurs. Removing fluid from the cornea starts leading to the reduction of corneal edema.
A 2015 study demonstrated an increased expression of several pro-inflammatory mediators at the protein level in the corneal epithelium in patients with pseudophakic corneal edema when treated with systemic L-cysteine.
Current Bullous Keratopathy treatment options have limitations. Symptomatic treatments are effective only in the early stages and do not address the root cause or offer a long-term solution. Corneal transplantation, while standard, carries risks like infection, donor cornea rejection, and the need for long-term immunosuppressants. Additionally, increased transplant demand worsens the global donor tissue shortage. Advancing research, refining corneal endothelial regeneration techniques, and developing new therapies are essential to overcoming these challenges and enhancing disease management.
This section focuses on the uptake rate of potential Bullous Keratopathy drugs expected to be launched in the market during 2020-2034.
Bullous Keratopathy Pipeline Development Activities
The Bullous Keratopathy therapeutics market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The Bullous Keratopathy therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for bullous keratopathy.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on bullous keratopathy evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Texas Health Science Center, Illinois College of Optometry and Salus University in the US, Eberhard-Karls-University Tubingen in Germany, University of Manchester and the Manchester Royal Eye Hospital in the UK, and Juntendo University Shizuoka Hospital in Japan, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or bullous keratopathy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
As per the KOLs from the US, standardized guidelines are urgently required as there are no guidelines for an accurate diagnosis and management of bullous keratopathy. An understanding of the precipitating causes and the Etiopathogenesis will further help in framing a curative treatment regimen. As per the KOLs from the UK, despite significant advancements in treating corneal endothelial disease, including improvements from traditional endothelial keratoplasty to DSEK, DMEK grafts, and injectable endothelial treatments, corneal disease remains a major global cause of blindness.
As per the KOLs from Japan, bullous keratopathy most commonly develops following glaucoma surgery, although it can also occur after complicated cataract surgery and laser iridotomy. Additionally, old age is a significant risk factor, as endothelial cell count decreases with advancing age.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Bullous Keratopathy Therapeutics Market Access and Reimbursement
Although VYZNOVA is approved in Japan for treating bullous keratopathy, the US and EU markets crave licensed therapies. The current treatment relies on symptomatic management and surgical interventions. However, the costs associated with corneal transplantation, including pre-operative evaluations, surgical fees, postoperative care, and long-term medication use, pose financial burdens for patients. Hence, limiting access to treatment for individuals with limited financial resources or inadequate insurance coverage. Therefore, access to affordable treatments and interventions is a significant concern for individuals with bullous keratopathy. Developing cost-effective therapies and ensuring their availability to a broader population can reduce the burden on patients and healthcare systems.
Corneal transplant coverage
A corneal transplant is usually covered by private medical insurance and Medicare when deemed medically necessary. Out-of-pocket costs may include a specialty copay, a hospital copay, and coinsurance of 10-50% for the procedure up to the yearly out-of-pocket maximum allowance. Capital BlueCross considers corneal transplantation medically necessary for patients with bullous keratopathy. Similarly, Blue Cross Blue Shield of Massachusetts considers DSEK, DSAEK, DMEK, or DMAEK medically necessary to treat endothelial dysfunction, including bullous keratopathy.
PacificSource provides coverage for AMT, but prior authorization is required. PacificSource considers AMT or limbal stem cell transplantation for ocular surface reconstruction medically necessary when ALL following criteria are met:
A. Reconstruction of the corneal surface, as indicated for one of the following conditions:
B. Reconstruction of the surface of the conjunctiva, as indicated for one of the following conditions:
The Bullous Keratopathy therapeutics market report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Bullous Keratopathy Therapeutics Market Report Scope
Bullous Keratopathy Therapeutics Market Insights
Bullous Keratopathy Epidemiology Insights
Current Bullous Keratopathy Treatment Market Scenario, Marketed Drugs, and Emerging Therapies