Dr. Pravin U. Dugel
DME Treatments and Challenges
Dr. Pravin U. Dugel
OCS-01 Phase 2 Study Results
Dr. Pravin U. Dugel
OCS-01 Phase 2 Study : Case Studies
OCS-01 is an investigational drug and has not received regulatory approval for commercial use in any country. Some of the statements in the video reflect Dr. Pravin U. Dugel’s perception of the results from the phase 2 clinical trial in DME and some of the forward-looking statements reflect his opinion on potential future use of OCS-01 based on his clinical experience.
Dr. Anat Galor
OCS-02 AAU Presentation at ARVO
Dr. Victor Perez
OCS-02 DED Presentation at ARVO
OCS-02 is an investigational drug and has not received regulatory approval for commercial use in any country. The video presentations may contain some statements that reflect the presenter’s perception of the clinical trial results and some forward-looking statements that reflect the presenter’s opinion on potential future use of OCS-02 based on clinical experience.
One of our most advanced product candidates, OCS-01, has successfully completed a Phase 2 trial in DME (DX-211) with 144 patients providing the first proof-of-concept for a topical drug effect in retinal edema. If approved in DME, it has the potential to provide a new and potentially the FIRST non-invasive option for patients.
OCS-01 also successfully completed another Phase 2 trial in Inflammation and Pain following cataract surgery. Following the completion of both Phase 2 trials, an End of Phase 2 meeting was conducted with FDA and the product candidate is now moving into phase III in both indications.
OCS-01 has been developed using the OPTIREACH solubilizing nanoparticle (SNP) technology, a proprietary platform that enables the formulation of drugs as non-invasive topical treatments, a longer residence time on the eye surface and enhances their bioavailability in the relevant eye tissues.
OCS-02 is a novel topical anti-TNFα therapy. In Dry Eye Disease (DED), two positive Phase 2 proof of concept (PoC) studies have been conducted with OCS-02 and a surrogate molecule. The Phase 2a PoC, which enrolled 134 patients, successfully demonstrated the effect of OCS-02 on DED symptoms with a good tolerability and safety profile. If approved, OCS-02 has the potential to become the first topical biologic for DED.
In addition to DED, OCS-02 also successfully completed a PoC Phase 2a study in Acute Anterior Uveitis (AAU), another eye disease with ocular inflammation. As a result, OCS-02 is moving to phase 2b studies in both indications: DED and as a Steroid-Sparing treatment for Chronic Uveitis.
OCS-02 is based on an innovative biologic technology that allows for the development of a small, pharmacologically active, humanized single chain variable fragment antibody (scFv). The lower molecular weight of the fragment relative to the whole antibody allows for the development of a topical formulation with high concentration and the penetration into ocular tissues.
OCS-05 is a first-in-class peptidomimetic small molecule with neuroprotective activity that has shown positive results in animal models of neuroinflammation and neurodegeneration. Its mechanism of action is related to the activation of the trophic factor pathways such as IGF-1 and BDNF. In ophthalmology, this action can protect the nerve axons in conditions where the optic nerve is affected, such as in acute optic neuritis and glaucoma.
Based on positive preclinical data and results of a phase 1 safety and PK study in healthy volunteers, a phase 2a study was initiated (the ACUITY study) which is currently ongoing in Europe.
ACUITY is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis. In addition to safety, secondary outcome measures will include optic nerve anatomical measures and visual function measures.