Ophthalmic CRO Ora kept in ocular clinical trial pact with Axim

A close image of a blue eye
Ophthalmic CRO Ora will provide clinical services to Axim's cannabinoid-based glaucoma and dry eye candidates.

Axim Biotechnologies, which explores medical uses of cannabis, has decided to continue contracting Ora to manage its drug R&D activities and clinical trials on glaucoma and dry eye.

Prof. Robert Ritch, chief of glaucoma services at New York Eye and Ear Infirmary of Mount Sinai School of Medicine, will oversee Ora’s clinical services provided to Axim, according to a release put forward by Axim. As a renowned expert in ophthalmology, Ritch became a member of Axim’s advisory board last December.

New York-based Axim focuses on cannabis for pharmaceutical, nutraceutical and cosmetic applications. According to the company’s website, it currently has two ophthalmic preparations, both cannabinoid-based therapeutics, in its pipeline ready for clinical testing—AX-1603 for glaucoma and AX-1606 for dry eye.

“Despite new product approvals, glaucoma and dry eye remain ophthalmic diseases with significant unmet medical needs,” said Ora’s CMO David Hollander, M.D., in a statement. “Approximately 40% of glaucoma patients require more than one IOP-lowering medication. We hope that the development of new treatments with novel mechanisms of action will in turn reduce the risk of progression of visual field loss.”

The Andover, Massachusetts-based CRO has been focusing specifically on ophthalmic treatments in, besides dry eye and glaucoma, allergy, medical devices, anti-infective and anti-inflammatory, etc. Services it offers span almost the full spectrum of a CRO, from preclinical and clinical management all the way to regulatory guidance.

During Ora’s 40-year history, it has helped nail 44 product approvals for its clients, the company said. Its client list includes some industry big names like Allergan, Novaliq, Bausch + Lomb, as well as smaller specialty biotechs like Mimetogen. The CRO was involved in two latest NDAs for Bepreve and Lastacaft.