Dry Eye Disease Market: Latest Drug Innovations & Developments
According to Inkwood Research’s projections, the global dry eye disease market growth is estimated to progress at a CAGR of 5.02% during the forecast period, 2024 to 2032. Further, the market is set to capture a revenue of $8884.34 million by 2032. As per a study on the incidence and prevalence of dry eye disease in the United States, the dry eye disease (DED) prevalence was 5.28% overall, with 2.96% male beneficiaries and 7.78% female beneficiaries.
As per another study on the economic burden of dry eye disease in the United States, DED incurred $55.4 billion in costs annually. Hence, with the rising prevalence and economic burden, the demand for advanced dry eye disease treatments is driving innovation. Recent FDA approvals and novel therapies are further set to revolutionize patient care, with drugs designed as per specific DED indications ushering in a new era in dry eye disease management.
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Aligning with this, in January 2024, Alcon announced positive topline results from its Phase 3 COMET trials for AR-15512, a novel topical drug candidate targeting dry eye disease. AR15512, a first-in-class TRPM8 agonist, successfully met the primary endpoint in both the COMET-2 and COMET-3 pivotal efficacy and safety studies (p < 0.0001), demonstrating promising results for treating the signs and symptoms of dry eye disease.
Accordingly, this blog focuses on some of the recent strategic developments related to dry eye disease drugs.
New Drug Application (NDA) for Reproxalap by Aldeyra Therapeutics
In February 2023, Aldeyra Therapeutics announced the US Food and Drug Administration’s (FDA) approval for the New Drug Application (NDA) for topical ocular Reporxalap. The company develops innovative therapies designed to treat immunemediated diseases. The NDA is supplemented by previously announced efficacy and safety results from well-controlled and adequate clinical trials. These encompass data for ocular redness, Schirmer test ≥10 mm responder analysis, Schirmer test, ocular redness, and ocular dryness symptom score.
Reporxalap is a first-in-class investigational new drug candidate for treating the symptoms and signs of dry eye disease. In dry eye disease patients, RASP (reactive aldehyde species) may facilitate changes in tear lipid composition, ocular redness, diminished tear production, and ocular inflammation. Accordingly, Reproxalap presents a differentiated and novel approach for treating the symptoms of dry eye disease.
As stated by Todd C. Brady, MD, Ph.D., President and Chief Executive Officer of Aldeyra, “NDA acceptance marks a critical regulatory milestone for Aldeyra as reproxalap continues to advance toward potential regulatory approval for the treatment of dry eye disease.” (Source)
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New Drug Application (NDA) for CyclASol® by Novaliq
On 24th October 2022, Novaliq announced the US FDA approval of the New Drug Application (NDA) for CyclASol®. It is a novel anti-inflammatory product for treating signs and symptoms of dry eye disease. It is preservative-free due to the novel carrier and contains no oils or surfactants. It offers additional clinical benefits like reduced visual disturbances and enhanced tolerability.
According to Christian Roesky, Ph.D., CEO, Novaliq, “This is an exciting time for ophthalmologists and optometrists and their patients as we are one step closer to address important needs and to better treat a serious ocular surface condition affecting millions of Americans. If approved, CyclASol® would be a highly potent but comfortable antiinflammatory therapy for patients with dry eye disease.” (Source)
Kala’s Announcement to sell INVELTYS® and EYSUVIS®
Kala Pharmaceuticals, in May 2022, announced its entry into a definitive agreement to sell its intellectual property assets and commercial portfolio to Alcon Inc. This entails INVELTYS®, a corticosteroid for treating post-operative pain and inflammation following ocular surgery. Alongside EYSUVIS®, the first and only United States Food and Drug Administration (FDA)-approved medicine for the short-term treatment of symptoms and signs of dry eye disease. Kala will receive an advance payment of $60 million and be eligible for commercial-based sales milestone payments.
Mark Iwicki, Chief Executive Officer and Chairman, Kala, said, “The sale of EYSUVIS and INVELTYS is an important step as we execute on our strategic plan and pursue our mission of delivering innovative therapies that can address significant unmet needs in ophthalmology.” (Source)
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OptiLight by Lumenis
In April 2021, Lumenis Ltd announced the grant of FDA approval for its newest intense pulsed light (IPL) device. Subsequently, Lumenis launched OptiLight™, a bright solution for dry eyes.
Intense pulsed light (IPL) therapy is a new treatment for rosacea and evaporative dry eye. Meibomian gland dysfunction (MGD) increases the severity of dry eye disease (DED) and can clinically impact the patient’s quality of life. Intense pulsed therapy (IPL) can benefit dry eye by enhancing the dysfunction of the meibomian glands.
OptiLight™ is patented with Lumenis’ OPT® technology and is designed for a controlled, precise, and consistent light-based treatment of dry eye disease.
Dr. Steven J. Dell, the lead investigator in the Lumenis’ clinical trial for the FDA and medical director of Dell Laser Consultants, said, “We deal with dry eye every day, but unless we address the underlying inflammation, it’s difficult to meaningfully impact the disease. OptiLight™ helps us to address the inflammation, as shown in Lumenis’ IPL clinical trials, and improves signs of dry eye disease due to MGD, positioning it as a valuable tool in our dry eye toolkit.” (Source)
Ongoing Research & Development in the Global Dry Disease Market
As per several research investigations, dry eye is a lifestyle disease, and most of the population is vulnerable. Accordingly, there have been ongoing research and developments related to dry eye treatment and solutions. For instance, the European Dry Eye Network, a platform for the training and career development of 10 early-stage researchers (ESRs) in vision sciences, was established in Europe under Horizon 2020. Such platforms are predicted to enhance research efforts for dry eye disease treatment, subsequently influencing the global dry eye disease market growth.
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FAQs:
1. Which countries have lucrative prospects in the global dry eye disease market?
A: Developing countries, such as China and India, have lucrative growth prospects in the global dry eye disease market.
2. What are the risk factors of dry eye disease?
A: As per global experts, the non-modifiable risk factors of dry eye disease are age, connective tissue diseases, Meibomian Gland Dysfunction, Sjogren’s syndrome, etc.