Q&A: Licaminlimab may offer precise approach to DED instead of ‘trial and error’
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Topline results from the phase 2b RELIEF trial demonstrate that licaminlimab has the potential to reshape the treatment paradigm of dry eye disease, offering a more precise strategy than current methods.
As Healio recently reported, the multicenter, randomized, masked, vehicle-controlled study showed improvements in multiple sign efficacy endpoints for licaminlimab in patients with dry eye disease, with more pronounced effects in patients with a TNFR1 genetic biomarker.
Healio spoke with Riad Sherif, MD, CEO of Oculis, about the study results and what this development could mean for practicing optometrists.
Healio: What do the results of this study mean for eye care providers?
Sherif: The current approach of “trial and error” and inability to appropriately treat this highly heterogeneous population leads to frustration, with only 13% of patients experiencing lasting relief. Patients can end up trying multiple therapies, placing the burden on them to find what works or not. Lack of efficacy and adverse events are the primary documented reasons for switching DED treatment.
The amplification of the treatment effect shown with licaminlimab in patients with the TNFR1 genetic biomarker highlights its potential to be the first precision-medicine approach in DED.
Predicting high-responders to licaminlimab with a simple genetic test (qPCR) is designed to facilitate the selection of treatment by eye care practitioners and ultimately improve patient outcomes.
Healio: Did anything about the study results surprise you?
Sherif: In the prior phase 2 trial, licaminlimab showed a sevenfold increase in treatment response on ocular discomfort in TNFR1 genetic-positive patients. In the RELIEF trial, we were very excited to see the consistency of results with the predictive and more pronounced effects of licaminlimab on multiple signs in patients with the biomarker, including a fivefold higher response on inferior corneal staining in particular.
Corneal staining is reflective of inflammation and apoptosis, which play crucial roles in DED, and is also the most commonly assessed sign in clinical practice, as it can affect quality of vision.
A precision-medicine approach has the potential to transform the way we develop drugs and treat patients in eye care.
Healio: Is there anything else you would like to add?
Sherif: Licaminlimab has the potential to be disease-modifying with its anti-TNF-alpha dual mechanism of action, as inflammation and apoptosis are directly linked to the pathogenesis of DED.
A precision-medicine approach with a simple biomarker test to help predict which patients will experience a pronounced treatment response to licaminlimab would be groundbreaking for this highly heterogeneous and unsatisfied DED patient population.
Furthermore, the rapid onset in this subpopulation and high drop-comfort level similar to artificial tears could alleviate some of the remaining unmet medical needs.
On a development front, running phase 3 studies in only TNFR1 genetic-positive patients could support a faster, smaller and cheaper path to approval and, more importantly, a higher probability of success, given the outsized effect seen to date in the biomarker population on both signs and symptoms.
Commercially, the precision-medicine approach could help patient access and reimbursement by payers, given the higher likelihood of good outcomes for biomarker-selected patients.
Reference:
- Licaminlimab in dry eye disease relief topline results. https://oculis.gcs-web.com/static-files/a20a9020-3ab1-44f5-bf13-45921c6b0e48. Published June 10, 2024. Accessed June 25, 2024.
For more information:
Riad Sherif, MD, is CEO of Oculis. He can be reached at IR@oculis.com.
Perspective
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That is because patients have a basic expectation of finding an optimal treatment for their disease without months to years of trial and error. Up until now, we have not had great strategies to achieve this.
Despite eye doctors routinely conducting multiple diagnostic tests to assess DED, such as a Schirmer test to evaluate tear production and matrix metalloproteinase-9 to evaluate for inflammation, these tests have not translated into sufficient precision-based treatment algorithms for patients.
It would be groundbreaking to be able to predict who will respond to a particular therapy for this multifactorial disease. Licaminlimab could be the first precision medicine in dry eye with a specific genetic test for the accurate selection of treatment and outcome prediction. This would be a gamechanger for physicians and their patients.
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