Following the successful closing of its Phase 3 OPTIMIZE Trial for OCS-01, Oculis is set for the next phase. If approved, OCS-01 has the potential to become a new standard of care as the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.
Ophthalmologists currently rely on topical steroids to treat ocular inflammation. The full regimen following ocular surgery often includes steroids, antibiotics and NSAID, which can require several drops daily for a post-op patient to self-administer, which may lead to compliance issues. Addressing this gap is Oculis Holding AG, a global biopharmaceutical company dedicated to saving sight and improving eye care.
The company leverages its proprietary OPTIREACH® technology for OCS-01, a novel high-concentration (15 mg/ml), preservative-free, topical formulation of dexamethasone. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling less frequent administration for front-of-the-eye and the drug passage from the eye surface to the posterior segment for back-of-the-eye diseases.
The completed OPTIMIZE (Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) trial on OCS-01 was a double-blind, placebo-controlled Phase 3 trial conducted in 25 sites across the US with 241 patients randomized 1:1 to receive once daily (QD) OCS-01 eye drop (n=119) or vehicle (n=122) for fourteen (14) days following cataract surgery. The trial met both hierarchical primary efficacy endpoints, the absence of inflammation at Day 15 and the absence of pain at Day 4, with robust statistical significance.
Furthermore, OCS-01 was well tolerated with a favourable safety profile. Overall, a higher number of ocular treatment-emergent adverse events (TEAEs) were reported for the vehicle group (n=84) compared with the OCS-01 QD group (n=37). There was no meaningful difference in intraocular pressure (IOP) between treatment groups, with a mean change from baseline to Day 15 of -0.90 mmHg in both the OCS-01 group and vehicle group.
If approved, OCS-01 has the potential to become a new standard of care and the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery.
Phase 3 OPTIMIZE positive results follows the statistically significant top-line results of OCS-01 from stage 1 of the Phase 3 DIAMOND trial in Diabetic Macular Edema (DME) reported earlier this year, further highlighting the product’s potential for treating front- and back-of-the-eye diseases. The results also follow the initiation of the LEOPARD investigator-initiated trial evaluating the potential of OCS-01 for the treatment of Cystoid Macular Edema, one of the most significant causes of vision loss following cataract surgery.
(Press release/RAN)
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