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Bausch + Lomb has announced a pivotal advancement for BL1243 (tonabersat), a novel investigational oral treatment for dry Age-Related Macular Degeneration. Following a constructive FDA meeting, the company is paving the way for a 2027 clinical program initiation that could offer a non-invasive alternative for early-stage patients.
Bausch + Lomb has announced a pivotal advancement for BL1243 (tonabersat), a novel investigational oral treatment for dry Age-Related Macular Degeneration. Following a constructive FDA meeting, the company is paving the way for a 2027 clinical program initiation that could off...
Vaughan, Ontario – October 7, 2026 – The landscape of eye health is on the cusp of a significant transformation. Bausch + Lomb, a global leader in eye health, has announced a pivotal advancement in the development of BL1243 (tonabersat), a novel investigational oral treatment for dry Age-Related Macular Degeneration (AMD). This progress follows a constructive meeting with the U.S. Food and Drug Administration (FDA) that has provided a clear clinical development pathway, signaling renewed hope for millions battling this debilitating eye condition.
For too long, patients with dry AMD have faced limited treatment options, often confronting the gradual erosion of their central vision with a sense of helplessness. Bausch + Lomb's commitment to an oral therapy, offering a convenient, non-invasive alternative to existing approaches, marks a critical step forward in addressing this profound unmet medical need. This development, announced on October 6, 2026, positions BL1243 as a potential game-changer, particularly for earlier-stage patients.
Dry Age-Related Macular Degeneration (AMD) is a common, chronic, and progressive eye condition characterized by the gradual deterioration of the macula, the central part of the retina responsible for sharp, detailed vision, leading to blurred central vision and difficulty with tasks like reading and recognizing faces. It is typically marked by the accumulation of yellowish protein deposits called drusen and thinning of macular tissue, but does not involve abnormal blood vessel growth. Dry AMD accounts for approximately 80% to 90% of all AMD cases, making it the most prevalent form of the disease. While it rarely causes total blindness, it can significantly impair central vision, impacting daily activities and overall quality of life.
The global burden of AMD is substantial and growing. In 2026, an estimated 200 million people worldwide are living with some form of AMD, a number projected to surge to between 288 and 300 million by 2040 due to increasing global life expectancy and an aging population. In the United States alone, nearly 20 million adults aged 40 and older have AMD, with approximately 1.49 million Americans grappling with late-stage, vision-threatening forms of the disease in 2026.
The disease predominantly affects older adults, with the risk of advanced AMD increasing significantly with age. Individuals between 60-74 years old show a strong prevalence increase, and for those aged 75 and above, the risk can climb as high as 30%. The economic impact of AMD is also considerable, with the global age-related macular degeneration market valued at USD 10.1 billion in 2024, and projected to reach USD 23.41 billion by 2034, exhibiting a Compound Annual Growth Rate (CAGR) of 8.90% from 2026 to 2034. The dry AMD market specifically reached USD 3.1 billion across the top seven major markets (US, EU4, UK, and Japan) in 2025 and is expected to reach USD 5.2 billion by 2036, demonstrating a CAGR of 4.64% during 2026-2036.
The current treatment landscape for dry AMD highlights a significant and persistent unmet need. Historically, management has primarily involved lifestyle modifications, such as quitting smoking and weight management, and nutritional supplements like the AREDS2 formula, which may help slow progression from earlier to later stages. However, these approaches do not halt or reverse the disease.
In recent years, breakthroughs have led to the approval of intravitreal complement inhibitors, such as pegcetacoplan (Syfovre) and avacincaptad pegol (Izervay), by the FDA in 2023. These injectable therapies are designed to slow the rate of geographic atrophy (a severe form of dry AMD) progression by targeting the complement cascade, a part of the immune system implicated in AMD development. While these offer a measure of hope, they come with notable limitations:
Beyond injections, non-invasive photobiomodulation therapy, using specific wavelengths of light to stimulate cellular repair, was authorized by the FDA in January 2025 for dry AMD. While promising, it also requires frequent clinic visits, and real-world long-term benefits are still being assessed.
This therapeutic void, particularly for patients in the early and intermediate stages of dry AMD, underscores the urgent need for more accessible, less invasive, and effective treatment options. Many patients lose significant vision before they even qualify for existing treatments. An oral medication could dramatically improve patient adherence, convenience, and access, potentially enabling earlier intervention to preserve vision.
Enter BL1243 (tonabersat), Bausch + Lomb's investigational oral pharmaceutical candidate. This novel treatment is being developed to specifically target the biological processes believed to contribute to retinal damage in dry AMD. The advancement of BL1243 is particularly exciting because it represents an oral delivery method, a significant departure from the injections or specialized light therapies currently available or recently authorized.
Tonabersat, the active compound in BL1243, has a history of prior clinical experience in approximately 2,100 people across other retinal diseases. Notably, a 63-participant study conducted by the DRCR Retina Network in diabetic macular edema demonstrated that oral tonabersat (80 mg) showed evidence of target engagement and pharmacological activity and was well-tolerated. This existing data provides a foundation for its potential application in dry AMD, suggesting a favorable safety profile and a known mechanism of action that could modulate disease pathways.
While the precise, detailed mechanism of action for BL1243 in dry AMD is still undergoing clarification, Bausch + Lomb has indicated it aims to address underlying biological processes contributing to retinal degeneration. This could involve pathways such as complement cascade inhibition, visual cycle modulation, inflammation reduction, or the reduction of toxic byproducts that accumulate in the retina, all of which are implicated in dry AMD pathogenesis. The convenience of an oral pill cannot be overstated, offering patients a non-invasive way to potentially manage a chronic condition that currently demands frequent, often uncomfortable, clinical visits.
The recent "constructive meeting" with the U.S. Food and Drug Administration (FDA) on October 6, 2026, marks a crucial milestone for Bausch + Lomb and BL1243. A constructive FDA meeting, within the rigorous multi-stage drug development process, signifies that the regulatory agency has provided clear guidance and support, in principle, for the proposed clinical development path. This clarity reduces regulatory uncertainty and allows the company to confidently advance its program. The FDA drug development process typically includes discovery and development, preclinical research, clinical research (Phases 1-4), FDA review, and post-market safety monitoring, often spanning 10 to 15 years. Gaining FDA support at an earlier stage is a strong positive indicator for a drug's potential future.
The key outcomes of this meeting are:
This is particularly significant because the FDA's endorsement for an initial safety and pharmacokinetics study, with a clear path to Phase 2, demonstrates confidence in the therapeutic potential of BL1243 and its non-invasive oral delivery method.
Yehia Hashad, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Bausch + Lomb, emphasized the importance of this step. “Dry AMD represents a significant unmet need, particularly for patients earlier in the course of disease, and we believe there is a real opportunity to change how and when these patients are treated,” Dr. Hashad stated. He further highlighted that "The oral route of administration, prior clinical experience and potential application in earlier-stage disease make BL1243 a particularly compelling program as we continue building the next generation of treatments for eye health.”
Adding to this perspective, Phil Rosenfeld, M.D., Ph.D., Professor of Ophthalmology at Bascom Palmer Eye Institute, noted, “For people with dry AMD, a safe and effective oral treatment could offer an important new option. Treatment choices are limited for patients who have not yet developed irreversible vision loss. An oral therapy could provide a convenient, non-invasive alternative to treatments administered by injection into the eye. If successful, it could also give physicians an opportunity to intervene earlier in the course of disease.”
The successful development and eventual approval of an oral treatment like BL1243 could revolutionize the management of dry AMD.
The dry AMD treatment market is poised for substantial growth driven by such innovations. With the global AMD market projected to reach USD 23.41 billion by 2034 and the dry AMD segment itself forecasted to grow at an impressive CAGR of 11.6% from 2026-2034, therapies like BL1243 are vital for capturing this expanding market and meeting patient needs.
The prospect of an oral therapy for dry AMD is met with considerable optimism from the ophthalmic community. Experts recognize the critical need for options that can address the disease earlier and with greater patient ease. As Yehia Hashad articulated, Bausch + Lomb is dedicated to "building the next generation of treatments for eye health."
The path forward for BL1243 involves rigorous clinical trials. The planned initiation of the clinical program in 2027 will begin with an initial study focused on safety and pharmacokinetics, followed by a Phase 2 trial. These trials are crucial for demonstrating the drug's safety and efficacy in human subjects, collecting the data necessary for eventual regulatory approval. The typical clinical research phases include Phase 1 (20-100 healthy volunteers or patients), Phase 2 (up to several hundred patients), and Phase 3 (300-3,000 patients). Each phase is designed to progressively evaluate safety, effectiveness, and optimal dosing.
The journey from a promising drug candidate to an approved therapy is long and complex, but the clarity provided by the FDA meeting is an encouraging sign. This collaboration between regulatory bodies and pharmaceutical companies is essential to bringing innovative solutions to patients who desperately need them. The focus on early-stage dry AMD patients also represents a strategic shift, aiming to preserve vision before irreversible damage takes hold.
Bausch + Lomb's progress with BL1243 is more than just a scientific advancement; it's a beacon of hope for individuals living with dry AMD and their families. It underscores the continuous innovation in eye health, pushing the boundaries of treatment to deliver more effective, convenient, and accessible care.
Age-Related Macular Degeneration (AMD) is a progressive eye disease that causes central vision loss by affecting the macula, the part of the retina responsible for sharp, detailed sight. It is the leading cause of irreversible vision loss in older adults. There are two main types: wet AMD, characterized by abnormal blood vessel growth, and dry AMD, which involves the gradual deterioration of macular tissue and accounts for 80-90% of cases.
Bausch + Lomb's BL1243 (tonabersat) is a novel investigational oral treatment for dry AMD, distinguishing it from current FDA-approved therapies for geographic atrophy (a late stage of dry AMD) which require frequent intravitreal injections into the eye. It also differs from other non-invasive treatments like photobiomodulation therapy, which requires in-clinic light sessions. Its oral administration aims to offer greater convenience, accessibility, and potential for earlier intervention for patients.
Following the constructive FDA meeting on October 6, 2026, Bausch + Lomb plans to initiate its clinical development program for BL1243 in dry AMD in 2027. This program will begin with an initial study to evaluate the drug's safety and pharmacokinetics. If successful, this study is expected to pave the way for a Phase 2 trial, which will focus on patients with earlier-stage dry AMD who do not have advanced retinal damage.
The clinical development of BL1243 is in its early stages, with Bausch + Lomb expecting to initiate its clinical program in dry AMD in 2027, starting with an initial study and then moving to a Phase 2 trial. The entire drug development process, from discovery to FDA approval, typically takes 10 to 15 years, involving multiple phases of rigorous testing for safety and efficacy. Therefore, commercial availability would be several years in the future, dependent on successful clinical trial outcomes and regulatory approval.## A New Horizon in Vision Care: Bausch + Lomb Advances Novel Oral Treatment for Dry Age-Related Macular Degeneration (AMD)
Vaughan, Ontario – October 7, 2026 – The landscape of eye health is on the cusp of a significant transformation. Bausch + Lomb, a global leader in eye health, has announced a pivotal advancement in the development of BL1243 (tonabersat), a novel investigational oral treatment for dry Age-Related Macular Degeneration (AMD). This progress follows a constructive meeting with the U.S. Food and Drug Administration (FDA) that has provided a clear clinical development pathway, signaling renewed hope for millions battling this debilitating eye condition.
For too long, patients with dry AMD have faced limited treatment options, often confronting the gradual erosion of their central vision with a sense of helplessness. Bausch + Lomb's commitment to an oral therapy, offering a convenient, non-invasive alternative to existing approaches, marks a critical step forward in addressing this profound unmet medical need. This development, announced on October 6, 2026, positions BL1243 as a potential game-changer, particularly for earlier-stage patients.
Dry Age-Related Macular Degeneration (AMD) is a common, chronic, and progressive eye condition characterized by the gradual deterioration of the macula, the central part of the retina responsible for sharp, detailed vision, leading to blurred central vision and difficulty with tasks like reading and recognizing faces. It is typically marked by the accumulation of yellowish protein deposits called drusen and thinning of macular tissue, but does not involve abnormal blood vessel growth. Dry AMD accounts for approximately 80% to 90% of all AMD cases, making it the most prevalent form of the disease. While it rarely causes total blindness, it can significantly impair central vision, impacting daily activities and overall quality of life.
The global burden of AMD is substantial and growing. In 2026, an estimated 200 million people worldwide are living with some form of AMD, a number projected to surge to between 288 and 300 million by 2040 due to increasing global life expectancy and an aging population. In the United States alone, nearly 20 million adults aged 40 and older have AMD, with approximately 1.49 million Americans grappling with late-stage, vision-threatening forms of the disease in 2026.
The disease predominantly affects older adults, with the risk of advanced AMD increasing significantly with age. Individuals between 60-74 years old show a strong prevalence increase, and for those aged 75 and above, the risk can climb as high as 30%. The economic impact of AMD is also considerable, with the global age-related macular degeneration market valued at USD 10.1 billion in 2024, and projected to reach USD 23.41 billion by 2034, exhibiting a Compound Annual Growth Rate (CAGR) of 8.90% from 2026 to 2034. The dry AMD market specifically reached USD 3.1 billion across the top seven major markets (US, EU4, UK, and Japan) in 2025 and is expected to reach USD 5.2 billion by 2036, demonstrating a CAGR of 4.64% during 2026-2036.
The current treatment landscape for dry AMD highlights a significant and persistent unmet need. Historically, management has primarily involved lifestyle modifications, such as quitting smoking and weight management, and nutritional supplements like the AREDS2 formula, which may help slow progression from earlier to later stages. However, these approaches do not halt or reverse the disease.
In recent years, breakthroughs have led to the approval of intravitreal complement inhibitors, such as pegcetacoplan (Syfovre) and avacincaptad pegol (Izervay), by the FDA in 2023. These injectable therapies are designed to slow the rate of geographic atrophy (a severe form of dry AMD) progression by targeting the complement cascade, a part of the immune system implicated in AMD development. While these offer a measure of hope, they come with notable limitations:
Beyond injections, non-invasive photobiomodulation therapy, using specific wavelengths of light to stimulate cellular repair, was authorized by the FDA in January 2025 for dry AMD. While promising, it also requires frequent clinic visits, and real-world long-term benefits are still being assessed.
This therapeutic void, particularly for patients in the early and intermediate stages of dry AMD, underscores the urgent need for more accessible, less invasive, and effective treatment options. Many patients lose significant vision before they even qualify for existing treatments. An oral medication could dramatically improve patient adherence, convenience, and access, potentially enabling earlier intervention to preserve vision.
Enter BL1243 (tonabersat), Bausch + Lomb's investigational oral pharmaceutical candidate. This novel treatment is being developed to specifically target the biological processes believed to contribute to retinal damage in dry AMD. The advancement of BL1243 is particularly exciting because it represents an oral delivery method, a significant departure from the injections or specialized light therapies currently available or recently authorized.
Tonabersat, the active compound in BL1243, has a history of prior clinical experience in approximately 2,100 people across other retinal diseases. Notably, a 63-participant study conducted by the DRCR Retina Network in diabetic macular edema demonstrated that oral tonabersat (80 mg) showed evidence of target engagement and pharmacological activity and was well-tolerated. This existing data provides a foundation for its potential application in dry AMD, suggesting a favorable safety profile and a known mechanism of action that could modulate disease pathways.
While the precise, detailed mechanism of action for BL1243 in dry AMD is still undergoing clarification, Bausch + Lomb has indicated it aims to address underlying biological processes contributing to retinal degeneration. This could involve pathways such as complement cascade inhibition, visual cycle modulation, inflammation reduction, or the reduction of toxic byproducts that accumulate in the retina, all of which are implicated in dry AMD pathogenesis. The convenience of an oral pill cannot be overstated, offering patients a non-invasive way to potentially manage a chronic condition that currently demands frequent, often uncomfortable, clinical visits.
The recent "constructive meeting" with the U.S. Food and Drug Administration (FDA) on October 6, 2026, marks a crucial milestone for Bausch + Lomb and BL1243. A constructive FDA meeting, within the rigorous multi-stage drug development process, signifies that the regulatory agency has provided clear guidance and support, in principle, for the proposed clinical development path. This clarity reduces regulatory uncertainty and allows the company to confidently advance its program. The FDA drug development process typically includes discovery and development, preclinical research, clinical research (Phases 1-4), FDA review, and post-market safety monitoring, often spanning 10 to 15 years. Gaining FDA support at an earlier stage is a strong positive indicator for a drug's potential future.
The key outcomes of this meeting are:
This is particularly significant because the FDA's endorsement for an initial safety and pharmacokinetics study, with a clear path to Phase 2, demonstrates confidence in the therapeutic potential of BL1243 and its non-invasive oral delivery method.
Yehia Hashad, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Bausch + Lomb, emphasized the importance of this step. “Dry AMD represents a significant unmet need, particularly for patients earlier in the course of disease, and we believe there is a real opportunity to change how and when these patients are treated,” Dr. Hashad stated. He further highlighted that "The oral route of administration, prior clinical experience and potential application in earlier-stage disease make BL1243 a particularly compelling program as we continue building the next generation of treatments for eye health.”
Adding to this perspective, Phil Rosenfeld, M.D., Ph.D., Professor of Ophthalmology at Bascom Palmer Eye Institute, noted, “For people with dry AMD, a safe and effective oral treatment could offer an important new option. Treatment choices are limited for patients who have not yet developed irreversible vision loss. An oral therapy could provide a convenient, non-invasive alternative to treatments administered by injection into the eye. If successful, it could also give physicians an opportunity to intervene earlier in the course of disease.”
The successful development and eventual approval of an oral treatment like BL1243 could revolutionize the management of dry AMD.
The dry AMD treatment market is poised for substantial growth driven by such innovations. With the global AMD market projected to reach USD 23.41 billion by 2034 and the dry AMD segment itself forecasted to grow at an impressive CAGR of 11.6% from 2026-2034, therapies like BL1243 are vital for capturing this expanding market and meeting patient needs.
The prospect of an oral therapy for dry AMD is met with considerable optimism from the ophthalmic community. Experts recognize the critical need for options that can address the disease earlier and with greater patient ease. As Yehia Hashad articulated, Bausch + Lomb is dedicated to "building the next generation of treatments for eye health."
The path forward for BL1243 involves rigorous clinical trials. The planned initiation of the clinical program in 2027 will begin with an initial study focused on safety and pharmacokinetics, followed by a Phase 2 trial. These trials are crucial for demonstrating the drug's safety and efficacy in human subjects, collecting the data necessary for eventual regulatory approval. The typical clinical research phases include Phase 1 (20-100 healthy volunteers or patients), Phase 2 (up to several hundred patients), and Phase 3 (300-3,000 patients). Each phase is designed to progressively evaluate safety, effectiveness, and optimal dosing.
The journey from a promising drug candidate to an approved therapy is long and complex, but the clarity provided by the FDA meeting is an encouraging sign. This collaboration between regulatory bodies and pharmaceutical companies is essential to bringing innovative solutions to patients who desperately need them. The focus on early-stage dry AMD patients also represents a strategic shift, aiming to preserve vision before irreversible damage takes hold.
Bausch + Lomb's progress with BL1243 is more than just a scientific advancement; it's a beacon of hope for individuals living with dry AMD and their families. It underscores the continuous innovation in eye health, pushing the boundaries of treatment to deliver more effective, convenient, and accessible care.
Age-Related Macular Degeneration (AMD) is a progressive eye disease that causes central vision loss by affecting the macula, the part of the retina responsible for sharp, detailed sight. It is the leading cause of irreversible vision loss in older adults. There are two main types: wet AMD, characterized by abnormal blood vessel growth, and dry AMD, which involves the gradual deterioration of macular tissue and accounts for 80-90% of cases.
Bausch + Lomb's BL1243 (tonabersat) is a novel investigational oral treatment for dry AMD, distinguishing it from current FDA-approved therapies for geographic atrophy (a late stage of dry AMD) which require frequent intravitreal injections into the eye. It also differs from other non-invasive treatments like photobiomodulation therapy, which requires in-clinic light sessions. Its oral administration aims to offer greater convenience, accessibility, and potential for earlier intervention for patients.
Following the constructive FDA meeting on October 6, 2026, Bausch + Lomb plans to initiate its clinical development program for BL1243 in dry AMD in 2027. This program will begin with an initial study to evaluate the drug's safety and pharmacokinetics. If successful, this study is expected to pave the way for a Phase 2 trial, which will focus on patients with earlier-stage dry AMD who do not have advanced retinal damage.
The clinical development of BL1243 is in its early stages, with Bausch + Lomb expecting to initiate its clinical program in dry AMD in 2027, starting with an initial study and then moving to a Phase 2 trial. The entire drug development process, from discovery to FDA approval, typically takes 10 to 15 years, involving multiple phases of rigorous testing for safety and efficacy. Therefore, commercial availability would be several years in the future, dependent on successful clinical trial outcomes and regulatory approval.
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