Oculis Successful End-Of-Phase 2 Meeting With The FDA, On Towards Phase 3

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Oculis, the Icelandic-Swiss clinical stage boipharmaceutical company recently announced that they are progressing towards Phase 3 with OCS-01 in two ophthalmology indications after the End-of-Phase 2 meeting with the FDA is completed.

The CEO of Oculis, Riad Sherif said: “We are very pleased with the guidance received from FDA on key elements of the Phase 3 programs that will support the submission of a New Drug Application (NDA) in both of our targeted indications,”. The recent announcement also introduced the new Vice President of Oculis, David P. Bingaman, who will be responsible for the global clinical development for the company. David Bingaman told the “The potential of Oculis’ pipeline candidates is very exciting. I am convinced that if the advanced product candidates, as well as the topical formulation technologies, come to market, they will have a positive impact on the vision and quality of life of millions of people worldwide.” and stated that “Oculis is at a pivotal time in its development and I am very much looking forward to joining the team to advance these innovative candidates towards patients in need.” [1]

Earlier this year we reported that OCS-01 proved successful in Phase 2 for both diabetic macular edema (DME) and for treating inflammation and pain after cataract surgery [2, 3].

OCS-01 is the brainchild of renowned Icelandic scientists, Thorsteinn Loftsson and Einar Stefánsson, who co-founded of Oculis. They have long been studying drug/cyclodextrin complexes for ophthalmic drug delivery. Their invention, which Oculis now calls „solubilizing nanoparticle” (SNP) technology is based on the aggregation of drug/cyclodextrin complexes, which forms stable nanoparticles of the complex aggregates that can fall apart upon dilution. Figure 1 shows the steps of the formation of the nanoparticles. According to the available information, OCS-01 contains 1.5% dexamethasone. Oculis did not publish the type of cyclodextrin used, although, looking over Prof. Loftsson’s publications, it is not that difficult to figure out the identity of the cyclodextrin.

References:

[1] Oculis Announces Successful End-Of-Phase 2 Meeting With The FDA For OCS-01 In Two Ophthalmology Indications; Oculis; https://oculis.com/2020/07/27/oculis-announces-successful-end-of-phase-2-meeting-with-the-fda-for-ocs-01-in-two-ophthalmology-indications/

[2] Oculis aces the Phase 2 clinical trial for OCS-01 treating DME (2020) Cyclodextrin News; https://cyclodextrinnews.com/2020/02/12/oculis-phase-2-clinical-trial-ocs-01-dme/

[3] Oculis Top-Line data from Phase 2 clinical trial for OCS-01 treating inflammation and pain after cataract surgery (2020) Cyclodextrin News; https://cyclodextrinnews.com/2020/05/20/oculis-top-line-data-from-phase-2-clinical-trial-for-ocs-01-treating-inflammation-and-pain-after-cataract-surgery/

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