US-based companies Ocular Therapeutix and Regeneron are collaborating to develop a sustained release formulation of the vascular endothelial growth factor (VEGF) trap aflibercept to treat wet age-related macular degeneration (wet AMD) and other serious retinal diseases.
Under the agreement, the companies will develop a sustained release formulation suitable for advancement into clinical development. At present, the formulation is in preclinical development.
Regeneron will develop and commercialise the formulation after exercising an option to obtain an exclusive licence for use of Ocular’s hydrogel-based technology.
Once the option is exercised, Ocular will receive $10 million from Regeneron and would fund the development through Phase I.
All rights to develop its hydrogel-based drug delivery platform with all other non-VEGF targeting compounds, as well as with small molecule pharmaceuticals will be retained by Ocular.
It will also receive up to $305 million from Regeneron for a sustained release version of aflibercept.
Ocular Therapeutix CEO and chairman Amar Sawhney said: “We have made considerable progress in developing our protein drug delivery platform at Ocular Therapeutix, so it is good to see an industry leader such as Regeneron recognising the potential of this technology.
“This sustained release formulation could have the potential to significantly reduce dosing frequency and subsequently reduce doctor visits, therefore reducing the burden of care for patients, caregivers and physicians, and may decrease the likelihood of certain side effects associated with frequent intravitreal injections.”
The US Food and Drug Administration (FDA) had approved Regeneron’s aflibercept for certain indications under the brand name Eylea.
Sustained-release hydrogel-based drug delivery depots are currently being developed by Ocular for intravitreal injection.
This can be formulated with both small and large molecule pharmaceuticals, such as tyrosine kinase inhibitors (TKIs) and protein-based anti-VEGFs, respectively.
These are aimed at delivering sustained and therapeutic levels of drugs to targeted ocular tissues.
Image: A human eye tissue affected by macular degeneration. Photo: courtesy of Andy Nestl.