Addressing significant unmet medical needs for transformative topical therapy
OCS-01 phase 2 study results in DME
Interviews with Dr. Pravin U. Dugel
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.
OCS-01: A potential paradigm
shift in DME treatment
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 on a chronic retinal disease. 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 from Oculis’ 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-01: A potential treatment
for Post-cataract Surgery Inflammation
OCS-01 successfully completed a Phase 2 trial in Inflammation and Pain following cataract surgery (SKYGGN trial) with 153 patients providing the first proof-of-concept of a once daily topical steroid. A long-acting topical solution, such as OCS-01, has the potential of reducing the burden of administration given that patients undergoing cataract surgery are usually on several medications daily.
OCS-01 also successfully completed another Phase 2 trial in DME. 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 from Oculis’ 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: THE POTENTIAL OF
topical anti-TNF alpha
therapy for ophthalmic
indications
The compound, named OCS-02, is based on a proprietary single-chain antibody fragment technology specifically designed for topical delivery. Efficacy and safety were evaluated in three clinical trials including two controlled studies under IND. The studies demonstrated a promising profile for treating inflammatory conditions of the anterior segment of the eye including Uveitis and Dry Eye Disease.