Can a topical treatment beat blockbuster eye injectables? A Swiss biotech has the cash now to find out
The eye disease therapy market is a lucrative one but a pain for patients who must rely on invasive injections a few times per year. A Swiss biotech is hoping to rewrite the game with a pair of lead topical drugs, and it’s got a fresh round of cash in its war chest to get there.
Oculis has bagged a $57 million Series C it will use to advance lead drug OCS-01 into late-stage trials in its bid to unseat in-the-eye injectables for eye disease as well as push ahead another candidate, OCS-02, the company said Tuesday.
The international syndicate on Oculis’ round was co-led by new investors BVCF Management and Hyfinity Investments, giving Oculis some juice as it begins a slate of late-stage studies in the US and abroad. First up is OCS-01, which Oculis will move into Phase III trials for diabetic macular edema as well as complete registrational studies for the treatment of inflammation and pain following ocular surgery.
The first of the Phase III studies is expected to kick off this quarter, CEO Riad Sherif told Endpoints News, with enrollment primarily focused in the US. Oculis is focusing much of its potential commercial strategy around the US and China, where Sherif said an effective topical product could offer a far more convenient option than the current injectables.
“We know that in the US, the average injections per year (for these patients) are around three, while in clinical trials they are given between 10 and 12 times per year,” Sherif said. “We do not have any topical products — like nothing — therefore, it’s pretty transformative for patients.”
OCS-01 is developed using Oculis’ SNP technology — that’s solubilizing nanoparticles — which it says can make drugs into a topical solution. Meanwhile, OCS-02 is a TNF inhibitor Oculis hopes to advance into Phase IIb trials targeting dry eye disease and chronic anterior uveitis as an alternative to steroids. The molecule has shown promise in two prior proof-of-concept studies, Oculis said, and turned out an interesting genotype biomarker on review that Sherif said could open the doors for use as the first personalized options for dry eye disease patients.
If all goes to plan, Oculis will begin reading out data from those four focal point studies in the June/July time frame next year, Sherif said, with the OCS-02 studies expected to read out in Q4 2022 and then mid-2023.
The company currently sports 20 employees as well as a strong network of contract researchers. The plan is to bring full-time staff up to about 30 or 35, with a focus on adding R&D functions in the short term, Sherif said.
In addition to BVCF and Hyfinity, the round was joined by new investors VI Partners and Wille AG, and existing investors Bay City Capital, Brunnur Ventures, EarlyBird, funds managed by Tekla Capital Management, Pivotal bioVenture Partners, Nan Fung Life Sciences, Novartis Venture Fund, Silfurberg, and others.
Editor’s Note: This story has been updated to correct an error. Only Oculis OCS-01 is developing using SNP technology.