Oculis in-licenses neuroprotective drug candidate for glaucoma

Glaucoma is a leading global cause of irreversible blindness and current treatments focus on lowering interocular pressure. Lausanne-based Oculis, dedicated to addressing unmet medical needs in ophthalmology with breakthrough innovations, is strengthening its pipeline to address glaucoma.

The company has signed an in-licence agreement with Accure Therapeutics to develop and commercialize ACT-01, which is being renamed OCS-05. The drug candidate is a first-in-class peptidomimetic with a distinct mechanism of action that activates neurotrophic signalling pathways to protect and prevent damage to the optic nerve and retina.

This drug has the potential to be disease-modifying in other lead indications such as geographic atrophy, acute optic neuritis (AON) and other optic neuropathies, as well as neurodegenerative diseases. It has been granted orphan drug designation in acute optic neuritis (AON) by both the US FDA and the EMA in the EU. It has completed a Phase 1 trial in healthy volunteers and is currently in a proof-of-concept trial for AON, with results due in the second half of 2023.

As part of their agreement, Accure Therapeutics will receive an upfront payment, potential milestone payments upon the achievement of certain development and commercial milestones, and tiered royalties on sales. If further development of the program is successful, Accure could be set to receive staged payments, which could reach up to $1 billion in value.

The deal is a key part of Oculis’s strategy to become a global ophthalmology leader bringing breakthrough innovations to the top three segments of the ophthalmology market: retina, dry eye and glaucoma, which represent ~84% of global sales. Oculis’ management team has extensive experience in bringing ophthalmology drugs to market, including several former Novartis executives, and has financial backing from leading investors worldwide, including Novartis Venture Fund. It is steadily building a pipeline of drugs that aim to transform the ophthalmology space, including a drug in-licensed from Novartis that aims to be the first topical biologic to treat Dry Eye Disease. It has operations in the US, Europe and China.

(Press release)