Enter PEG hydrogel platform
One deliverable of this effort is a proprietary polyethylene glycol (PEG) hydrogel platform technology (Ocular Therapeutix).
Previously approved for use in spinal, neurological, and angioplasty procedures, the company is now engineering the hydrogel technology to design therapies specifically for sustained-release ocular drug applications.
The in situ formed hydrogel encapsulates the therapeutic molecule and releases the agent over time as the hydrogel degrades. Hydrogels possess a comfortable degree of flexibility similar to natural tissue, due to their significant water content.
The hydrogel platform is made of branched polymer chains that are covalently crosslinked, and can be engineered to increase or decrease the crosslink density, which alters their degradation rate. This means the hydrogel can be specifically programmed for a variety of disease states depending on the molecule’s properties and the desired duration of therapy required.
PEG-based materials have undergone extensive biocompatibility and safety testing and eliminate the risks associated with biological components, such as collagen or human thrombin.
Hydrogel technology enables the use of drugs that are known to be efficacious for ocular diseases and conditions when formulated as daily drops or monthly injections, into one-time or several-month dosage forms. The release of these drugs can be tailored to produce the required efficacy with the potential for an improved safety profile since they are used in lower peak concentrations and are preservative-free.
The company has created a way to encapsulate a wide range of pharmaceuticals within its hydrogel to provide targeted, sustained delivery of therapeutic levels of drugs to ocular tissues. Through containment, localization, and protection from inflammatory response, the hydrogel expands the utility of therapeutic molecules via more effective and consistent delivery.
Although not a drug product, the first and only FDA-approved sealant for ophthalmic use (ReSure Sealant, Ocular Therapeutix) is used to seal corneal incisions after cataract surgery. The sealant is prepared prior to application by mixing a proprietary PEG polymer with a diluent-activating solution, and the combination is applied over the incision.
It forms a pliable, adherent gel that is initially blue for visibility but quickly turns clear. The sealant will naturally slough off in 1 to 3 days after re-epithelialization. In the pivotal trial, the sealant was proven superior to sutures for prevention of fluid egress in clear corneal incisions with significantly fewer adverse events.1