Aerie Pharmaceuticals has started operations of its manufacturing facility, which will produce ophthalmic implants using the Particle Replication in Non-wetting Templates (PRINT) Technology platform, in the US.
The custom-designed 1,000ft² laboratory, established in an expanded global headquarters in Durham, North Carolina, will produce all of the clinical products that are needed for the company’s two lead development programmes focused on retinal diseases.
Aerie Pharmaceuticals chairman and CEO Vicente Anido said: “In addition to focusing on the commercialisation of our glaucoma franchise, we are actively engaged in building our pipeline, currently centred on our novel sustained release programme being designed to address unmet needs in the treatment of retinal diseases.
“Our scientists and engineers in Durham continue to advance the pipeline by pairing our proprietary molecules with sustained-release, bio-erodible polymers to deliver the full value of the innovative PRINT platform to our clinical programme in retina, which we expect to initiate later in 2019.”
The rights to use PRINT Technology in ophthalmology and certain other assets were bought by Aerie from Envisia Therapeutics in October last year.
At present, the company is evaluating the use of the technology for producing fully-biodegradable polymer implants capable of the sustained delivery of drug therapy to the back of the eye.
Furthermore, the technology is being analysed for release of therapies to the front of the eye.
Initially, the Good Manufacturing Practices (GMP) validated manufacturing laboratory will produce implants to support clinical trials of the AR-1105 (dexamethasone) implant.
Additionally, it will manufacture Aerie’s Rho kinase/Protein kinase C inhibitor, AR-13503 implant.
The implants will allow injections two times a year to treat sight-threatening retinal conditions such as diabetic macular oedema and neovascular age-related macular degeneration.
Aerie’s expanded headquarters facility now consists of a total of more than 61,000ft².