Retinal detachment is a serious condition, fortunately for which, there is a very effective laser treatment performed about 250,000 times a year in the US. For almost all of those cases, post-surgical care requires that the patient remain stationary with the head facedown with minimal movement and very low vision for seven days or more. The purpose of this regimen is to position a buoyant gas bubble placed by the surgeon to maintain pressure on the retina to promote healing and reattachment to the back of the eye. The gas is slowly resorbed and replaced by the natural vitreous humor that usually fills the eye. Two retinal specialists at the Massachusetts Eye & Ear (MEE) set out to find a better solution to the post-surgical care problem.
The eye is filled with a gelatinous substance, called vitreous humour, which must be removed to perform many ophthalmic procedures. The development of an optimal replacement material that closely mimics the natural substance has been a long sought-after research objective. The list of performance requirements for that substitute is challenging to meet. The best option to date has been the use of silicone oil. When used to refill the eye, it can maintain pressure on the retina, much like the gas bubble, but it has to be removed, and that requires a second surgery with the accompanying risks, expense, and inconvenience.
Dr. Thomasz Stryjewski and Dr. Anthony Stefater encountered the problem during their surgical residency at MEE. The literature describes many attempts over many decades to develop a suitable temporary material to refill the eye while the vitreous humor regenerates itself. The Pykus founders started their work in the library to identify previously described synthetic materials that might do the job as they defined it. The product would have to start as a watery liquid to be injected through a very small gauge needle and then transform itself rapidly inside the eye to a solidified gel. The material also has to be transparent, shelf-stable, colorless, non-toxic, non-swelling, non-allergenic and biodegradable - a long list of requirements. The composition they developed is a synthetic water-soluble polymer somewhat like the “slime” you see in kid’s toys and horror movies.
They refined the formulation so the product handling would be fit readily into the surgeon workflow and did extensive in vivo testing in rabbits and now pigs before seeking FDA approval for the first trial in humans next year.
The company, called Pykus Therapeutics, just completed its first round of venture capital financing, led by Partners Innovation Fund. The investment is expected to fund company operations through a proof-of-concept Phase I clinical study. This is the second company, in the PIF portfolio, emerging from MEE in less than a year since the merger with PHS. This is a demonstration of how the commercialization capabilities of the Innovation group can advance inventions from our research community into new ventures organized to bring them to market for the benefit of patients who need them.