Oculis Top-Line data from Phase 2 clinical trial for OCS-01 treating inflammation and pain after cataract surgery

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Oculis, the Icelandic-Swiss clinical stage boipharmaceutical company recently reported new clinical data at the Americal Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, held online. The presentation was given by Eric Donnenfeld, M.D., who is member of the scientific advisory board of Oculis.

We reported the news in February from the Phase 2 (DX-211) clinical trials of the OCS-01 nanoparticle formulation for treating diabetic macular edema (DME) with a simple eye drop without the need of an intraocular injection. [1]

This time they tested the same OCS-01 nanoparticle eye-drop formulation for the treatment of inflammation and pain in post cataract surgery patients. Oculis’ Phase 2 (SKYGGN) clinical trial ended with potitive “top-line” results according to the company, allowing once-a-day treatment of inflammation and pain in post-cataract patients. [2] ClinicalTrials.gov is a little slow in reaction, the last update of the study there was in October, while Oculis was still just recruiting. [3]

Before diving into the details, let’s take a sidetrack to examine the ethymology of the name of the trial. “Skyggn” is an Icelandic word for “sharp-sighted” or “clear-sighted”, thus the connection to the nanoparticle eye drop formulation. But “skyggn” could have another meaning for “clairvoyant” or “psychic”, possibly originating from the old sagas. Perhaps, Oculis could see the success for this clinical study beforehand. Yours truly is not a linguist, I just have some history with Iceland, but this double meaning was confirmed by the report from Oculis too.

According to Oculis: The objective of the SKYGGN study was to assess the efficacy and safety of OCS-01 applied once daily to treat inflammation and pain following cataract surgery. The trial was a multicenter, randomized (1:1:1), double-masked, vehicle-controlled Phase 2 study comparing OCS-01 dosed once a day (QD), OCS-01 dosed twice a day (BID) or vehicle for 15 days in 153 patients following cataract surgery. The study met both its primary endpoints:

  • Inflammation: the percentage of eyes with zero inflammation (absence of anterior chamber cells, cell = 0) was statistically significantly greater with OCS-01 QD compared to vehicle at Day 15 (OCS-01 QD, 51% vs. vehicle, 19.6%, p=0.0009)
  • Pain: the percentage of eyes with zero pain (absence of pain, score of 0) was statistically significantly greater with OCS-01 QD compared to vehicle at Day 4 (OCS-01 QD, 72.5% vs. vehicle, 54.9%, p=0.005).

The once-a-day administered OCS-01 was found to be well tolerated and safe. In fact, more “ocular treatment emergent adverse events” were reported in the group treated with placebo vehicle (=38), than in the group teated with OCS-01 (n=23). There was also no meaningful change in intra-ocular pressure mean change from the baseline between the OCS-01 vs. vehicle group. Twice-a-day administration was also tested, with similar success.

OCS-01 is the brainchild of renowned Icelandic scientists, Thorsteinn Loftsson and Einar Stefánsson, who co-founded 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.

Picture1

Figure 1. The formation of drug/cyclodextrin inclusion complexes and their subsequent aggreation to nanoparticles.

Cyclodextrin News looks forward to the future success of Oculis and hopefully soon there will be one more product on the market containing cyclodextrins.

 

 

References:

[1] 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/

[2] Oculis reports positive top-line data from SKYGGN (Phase 2) trial with OCS-01 for treating inflammation and pain following cataract surgery (2020) Oculis; https://oculis.com/2020/05/18/oculis-reports-positive-top-line-data-from-skyggn-phase-2-trial-with-ocs-01/

[3] OCS-01 in Treating Inflammation and Pain in Post-cataract Patients (SKYGGN); https://clinicaltrials.gov/ct2/show/NCT04130802

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