Unmet Medical Need: Efo/keratitis


1. Disease Summary:

Keratitis is an inflammation of the cornea, the clear front surface of the eye, which can be caused by infections (bacterial, viral, fungal, or parasitic), trauma, or exposure to harmful substances. Infectious keratitis is a significant cause of visual impairment and blindness worldwide, particularly in developing countries. The condition can lead to severe complications, including corneal scarring, perforation, and endophthalmitis, which can result in irreversible vision loss if not treated promptly.

2. Global Prevalence and Disease Burden:

Keratitis is a leading cause of preventable blindness globally. Approximately 4.9 million people are affected by bilateral blindness due to corneal diseases, which account for about 12% of total global blindness (PMID: 33760451). The incidence of infectious keratitis varies widely by region, with higher rates reported in low- and middle-income countries (LMICs) due to factors such as limited access to healthcare, poor hygiene, and higher rates of trauma. For example, Acanthamoeba keratitis, a rare but serious form, has an estimated incidence of 2.34 cases per 1,000,000 people (PMID: 39127408). The economic burden of keratitis is substantial, with costs associated with treatment, loss of productivity, and long-term care for those who suffer vision loss.

3. Unmet Medical Need:

Despite the significant burden of keratitis, there are several unmet medical needs in its management:
  • Access to Care: Many patients, especially in LMICs, lack access to timely and effective treatment. This is exacerbated by a shortage of trained healthcare professionals and inadequate healthcare infrastructure (source: Urgent unmet needs in the care of bacterial keratitis).
  • Diagnostic Challenges: Current diagnostic methods often fail to identify the causative organisms in cases of microbial keratitis, leading to inappropriate or delayed treatment. Studies indicate that conventional culture methods can miss causative pathogens in over 50% of cases (PMID: 31669750).
  • Treatment Limitations: Existing treatments, such as topical antibiotics, are often inadequate, particularly for fungal keratitis, where treatment failure rates can be as high as 25% (PMID: 33916767). There is a need for more effective antifungal agents and better drug delivery systems to enhance treatment outcomes.
  • Patient Education and Support: Patients often report difficulties in understanding their condition and treatment regimens, leading to poor adherence and outcomes. There is a need for improved patient education and support systems to help manage their care effectively (source: Patient priorities in herpes simplex keratitis).

4. Current Treatment Options:

Current treatment options for keratitis vary depending on the underlying cause:
  • Bacterial Keratitis: The first-line treatment typically involves topical antibiotics. However, the effectiveness of these antibiotics can be limited due to rising antimicrobial resistance (PMID: 36882242).
  • Fungal Keratitis: Treatment often includes antifungal eye drops, such as natamycin, but these are not always effective, and many patients may require surgical intervention (PMID: 33916767).
  • Viral Keratitis: Antiviral medications, such as acyclovir, are used for herpes simplex keratitis, but they do not eliminate the virus, leading to recurrent episodes (PMID: 32732703).
  • Neurotrophic Keratitis: Newer treatments, such as cenegermin (Oxervate), have been developed to promote corneal healing, but access to these therapies can be limited (PMID: 31596151).

5. Current Clinical Trials:

Several clinical trials are currently underway to address the unmet needs in keratitis treatment:
  • Novel Drug Delivery Systems: Research is focusing on innovative drug delivery methods, such as microneedle patches and drug-eluting contact lenses, to improve the efficacy of treatments (PMID: 31701781).
  • Antifungal Innovations: Trials are exploring new antifungal agents and combinations to enhance treatment outcomes for fungal keratitis (PMID: 37045836).
  • Patient-Centric Approaches: Studies are investigating the integration of patient feedback into treatment protocols to improve adherence and outcomes (source: Patient priorities in herpes simplex keratitis).

6. Additional Context:

The burden of keratitis is not only a public health issue but also a significant economic concern. The costs associated with treatment, loss of productivity, and long-term care for individuals who suffer from vision loss can be substantial. Addressing the unmet medical needs in keratitis requires a multifaceted approach, including improving access to care, enhancing diagnostic capabilities, developing more effective treatments, and ensuring that patients receive adequate education and support.
In summary, while there are existing treatments for keratitis, significant gaps remain in access, effectiveness, and patient management. Addressing these unmet needs is crucial for reducing the global burden of this sight-threatening condition.