Oculis yields positive results in phase 2 study

Oculis' topical treatments (eye drops) address ophthalmic diseases for both back- and front-of-the-eye in order to improve the sight and lives of patients worldwide. These topical treatments represent an unprecedented technical advance for patients with back-of-the-eye diseases that are currently managed only by intra-ocular injections or implants; while topical treatments for the front-of-the-eye disease are designed to improve patient outcomes by increasing drug bioavailability, reducing dosing frequency and improving patient compliance.

The company’s leading clinical candidates are OCS-01 and OCS-02. OCS-01 was developed using Oculis’ proprietary Soluble NanoParticle technology (SNP), which acts as an ocular drug carrier to enhance the bioavailability of drugs in the posterior segment of the eye.

The recent phase 2 study (DX-211) of OCS-01 met its pre-defined efficacy endpoints and showed that OCS-01 eye drops were more effective than vehicle in reducing central macular thickness and improving visual acuity in patients with DME. No significant/unexpected ocular adverse events were observed. If approved in DME, OCS-01 has the potential to provide a new non-invasive treatment option for DME patients.

Riad Sherif, CEO of Oculis, said: “We are delighted by the results. The DX-211 study validates the potential of OCS-01 to provide patients and their physicians with a potentially transformative topical approach for sight-threatening retinal diseases, such as DME. Furthermore, the study confirms the potential of our unique SNP technology to formulate additional topical therapies to treat back-of-the-eye diseases. The successful completion of this clinical trial, along with the support of the retina community, gives us great confidence for the next development steps ahead for OCS-01.”

"The results of the DX-211 study are very exciting as they clearly show that OCS-01 treatment improves the vision of DME patients as well as demonstrates an objective biological effect on the retina via the OCT measurements. In addition, the safety profile of OCS-01 appears encouraging and manageable, with the lack of local irritation and toxicity. I believe that the OCS-01 data are very promising and that further larger studies are warranted, which, if successful, could highlight an important role for OCS-01 in the routine management of DME patients, and particularly those at the early stages of the disease where a watch-and-wait strategy is currently employed,” said Pravin U. Dugel, M.D., Chairman of Oculis’ Scientific Advisory Board of Oculis.

 (Press release)