Silk Protein for Your Eyes?
SDP-4 offers a novel biotherapeutic approach that uses a naturally derived silk protein to treat Dry Eye Disease (DED) through a dual-mechanism of action. It has been designed to inhibit the inflammatory mediators that may promote the symptoms of DED. Additionally, since SDP-4 is a protein in nature, the design of the eye drop formulation is intended to utilize the inherent spreading and wetting properties that a soluble protein may impart on the eye’s surface to stabilize the tear film and potentially improve physical comfort. The eye drop is expected to be supplied in single-unit dose containers as a preservative free, water-based formulation that may be stored at room temperature.
It is estimated that up to 340 million people suffer from Dry Eye Disease (DED) worldwide, with 45 - 60 million people in the US alone. Estimates show that nearly 16 million patients are diagnosed with DED in the US [1], and further studies suggest up to an additional 30 – 40 million individuals may remain undiagnosed and could benefit from therapeutic treatment [2]. Recent evidence suggests the magnitude of the problem is increasing over time [3].
Dry Eye Disease (DED) is a disorder of the tear film which if left untreated may result in significant symptomatology characterized by discomfort, reduced visual function and when severe, general quality of life issues. When compromised, the tear film may become unstable and/or leave portions of the ocular surface uncovered and non-wetting. This can be caused by a number of irritating effects, which may be environmental or physiological in nature. Continued irritation to the ocular surface can create inflammation that over time may further destabilize the tear film and potentially worsen patient symptoms. SDP-4 is designed to counteract these effects by working to simultaneously stabilize the tear film with protein, while inhibiting inflammation, both of which may be responsible for DED symptoms.
SDP-4 is designed to simultaneously inhibit the inflammation that appears to be associated with DED, while stabilizing the tear film with added protein that is designed to address abnormalities of the pre-corneal mucin layer.
"SilkTech’s SDP-4 represents an innovative and potentially disruptive biological approach as a potential treatment for patients suffering from Dry Eye.”
The tear-film enhancing proteinaceous nature of SDP-4 is demonstrated by comparing the spreading properties of saline vs. saline plus SDP-4 on a hydrophobic surface phenotypical of a non-wetting corneal surface such as that potentially occurring in Dry Eye Disease (DED). SDP-4 (1%) enhances the wetting and spreading properties upon application without increasing viscosity. SilkTech is hopeful studies will show that this property will improve overall tear film stability thereby enhancing comfort without compromising vision quality.
It is estimated that up to 340 million people suffer from Dry Eye Disease (DED) worldwide, with 45 - 60 million people in the US alone. Estimates show that nearly 16 million patients are diagnosed with DED in the US [1], and further studies suggest up to an additional 30 – 40 million individuals may remain undiagnosed and could benefit from therapeutic treatment [2]. Recent evidence suggests the magnitude of the problem is increasing over time [3].
TARGETING THE DRY EYE INFLAMMATION CYCLE
Dry Eye Disease (DED) is a disorder of the tear film which if left untreated may result in significant symptomatology characterized by discomfort, reduced visual function and when severe, general quality of life issues. When compromised, the tear film may become unstable and/or leave portions of the ocular surface uncovered and non-wetting. This can be caused by a number of irritating effects, which may be environmental or physiological in nature. Continued irritation to the ocular surface can create inflammation that over time may further destabilize the tear film and potentially worsen patient symptoms. SDP-4 is designed to counteract these effects by working to simultaneously stabilize the tear film with protein, while inhibiting inflammation, both of which may be responsible for DED symptoms.
SDP-4 is designed to simultaneously inhibit the inflammation that appears to be associated with DED, while stabilizing the tear film with added protein that is designed to address abnormalities of the pre-corneal mucin layer.
"SilkTech’s SDP-4 represents an innovative and potentially disruptive biological approach as a potential treatment for patients suffering from Dry Eye."
The tear-film enhancing proteinaceous nature of SDP-4 is demonstrated by comparing the spreading properties of saline vs. saline plus SDP-4 on a hydrophobic surface phenotypical of a non-wetting corneal surface such as that potentially occurring in Dry Eye Disease (DED). SDP-4 (1%) enhances the wetting and spreading properties upon application without increasing viscosity. SilkTech is hopeful studies will show that this property will improve overall tear film stability thereby enhancing comfort without compromising vision quality.
Because of SDP-4’s unique solubility properties, the eyedrop formulation is water-based. The formulation is non-preserved and stable at room temperature.
“The field of protein-based treatments for Dry Eye could potentially represent key mechanisms needed to manage this challenging disease state more effectively. As a protein, SDP-4 provides a unique opportunity to evaluate what may be a significant contribution to addressing the symptoms of Dry Eye.”
The Phase 2 clinical trial (SDP-4-CS201) is a 300-patient, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0%, and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation dosed twice per day. The objective of this study is to meet a primary symptom improvement endpoint as evaluated using the SANDE questionnaire, with additional secondary sign and symptom endpoints included. Topline results from this study are expected in late 2019 and will be used to inform the design of future Phase 3 studies.