Oculis SA reported positive results from its phase 2 SKYGGN study of OCS-01, a novel, high concentration, preservative free, topical SNP formulation of dexamethasone (ophthalmic suspension 1.5%) for the treatment of inflammation and pain following cataract surgery.
OCS-01 has been developed using Oculis’ proprietary SNP technology to increase solubility and residence time of the active drug on the surface of the eye, with the aim of delivering an improved and clinically effective anti-inflammatory effect while reducing the frequency of topical administration.
The objective of 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).
OCS-01 QD was also found to be well tolerated and safe. Overall, a higher number of ocular treatment emergent adverse events (TEAEs) were reported for the vehicle group (n=38) compared to the OCS-01 QD group (n=23). There was no meaningful change in intraocular pressure (IOP); mean change from baseline was 0.74 mmHg (OCS-01 QD group) vs. 0.57 mmHg (vehicle group).
The efficacy and safety of OCS-01 in the BID cohort showed similarly favorable efficacy and safety as the QD cohort vs vehicle.
These positive clinical data were presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting by Eric Donnenfeld, MD, clinical professor of ophthalmology at New York University and Trustee of Dartmouth Medical School, on behalf of the SKYGGN study group. ASCRS 2020 was held online on May 16-17, 2020.
“The results of the SKYGGN trial are very impressive with OCS-01 administered once daily showing clear superiority in reducing inflammation and pain compared to vehicle,” Dr. Donnenfeld said in a company news release. “Patients who have undergone cataract surgery often have to self-administer eye drops several times a day to manage inflammation and pain. I believe these patients will benefit greatly from an effective, once-daily and preservative free treatment. OCS-01 is a very promising new candidate and I look forward to participating in the next stage of its clinical development.”
“We are delighted with the positive outcome of the SKYGGN trial. We have now reported positive phase 2 trials with OCS-01 in treating inflammation and pain following ocular surgery and for patients with diabetic macular edema (DME). These data reinforce the clear potential of OCS-01 and Oculis’ proprietary SNP formulation technology to provide topical formulations that are administered less frequently for front-of-the-eye diseases, and importantly, to enable the development of eye drops for retinal diseases, which are currently treated with injectables or implants,” said Riad Sherif, MD, Chief Executive Officer of Oculis. “We plan to meet with regulators in the coming weeks to discuss these data and the clinical development steps needed to progress OCS-01 towards registration. We are very excited about the prospects for OCS-01 and look forward to providing further updates of progress.”