Opko Health (Miami), which includes in its portfolio a retinal imaging device and an ophthalmic drug in development, has now acquired exclusive worldwide rights to a device to be used following invasive retinal procedures to prevent a serious infection.

The device, as yet unnamed, was licensed from its two inventors, retinal surgeons who are also clinical advisors to Opko. Terms of the licensing arrangement were not disclosed.

This infection is known as endophthalmitis and it can lead to loss of vision and, potentially, the removal of the eye. The infection produces inflammation of the intraocular cavities of the eye, typically resulting as a complication of ocular surgery, intraocular injections or trauma — that can leave holes from the needle injection or other openings that then allow entry for infection.

Samuel Reich, executive VP of opthalmologics for Opko, told Medical Device Daily that the small device is collagen-based and shaped like a donut or bagel. Opko Health was named eXegenics until it changed the company name in June (Medical Device Daily, June 25, 2007).

The device is a size such that it fits over the eyeball, but does not extend beyond the eye itself.

“It covers the sclera, but doesn’t make contact with the cornea,” he said. “This device [protects] those incisions or holes or wounds, while they themselves heal over,” in the area of the sclera where incisions or injections have been made.

Reich went on to explain: “While [the wounds] are open and uncovered, the eye is susceptible” to endophthalmitis, which he termed “very, very serious — a terrible thing to have happen ...”

Because this protective device is made of collagen, it is “a very safe and innocuous material that will dissolve over time, so it doesn’t have to be taken off or removed or disposed of,” he added.

The device was invented by two retinal surgeons who serve as clinical advisors to Opko and licensed the technology to the company.

According to Opko, eye health experts are “raising the alarm” about a significant increases in cases of endophthalmitis. These experts believe that the incidence of endophthalmitis is growing as a result of a much larger number of ocular surgeries being performed, as well as the widespread adoption of sutureless surgical techniques and a significant increase in the number of intravitreal injections.

With the advent of injectable therapies such as Lucentis for the treatment of wet age-related macular degeneration, or wet AMD — and an increasing problem among Baby Boomers — the annual number of injections has risen rapidly, according to the company. Opko reports that the number of invasive retinal procedures currently performed in the U.S. alone is estimated to be more than 1.5 million annually.

These procedures include both surgeries and intravitreal injections, and though most patients suffer no adverse events from such surgeries or injections, all such patients are at risk for this type of infection.

“Endophthalmitis is a complication dreaded by eye care professionals, since its outcome is so devastating for patients,” said Richard Kaiser, MD, a retinal specialist at the Wills Eye Institute (Philadelphia) who is one of the co-inventors of the device and author of a forthcoming paper in the journal, Ophthalmology.

As surgical procedures have changed over time, so have the associated risks that come with the, and, according to the company, Kaiser’s paper shows a greater than 12-fold increase in the likelihood of endophthalmitis when retinal surgeons use sutureless compared to older approaches.

“As practicing retinal surgeons, we designed this collagen-based device specifically for routine use after retinal surgeries and intravitreal injections. We are optimistic that this new product will be effective in helping to reduce the risk of this catastrophic complication among retinal patients,” Kaiser said.

Reich told MDD that Opko’s device — still in development — is the first to be designed and optimized to prevent this infection from occurring. Though still a “little bit premature,” Opko’s research shows “minimal work” will need to be done to meet any regulatory requirements, Reich said.

Earlier this month, Opko reported that it has acquired exclusive worldwide rights from an unnamed source for ophthalmic uses to a topical clinical stage compound with potential utility in the treatment of dry eye.

The compound, civamide, is a TRPV-1 receptor modulator and neuronal calcium channel blocker and is in Phase III trials.

Opko’s lead investigational drug is bevasiranib, a gene-silencing agent for wet AMD and diabetic macular edema that has entered a pivotal Phase III trial.

Currently, the company markets diagnostic systems, i.e, a retinal imaging device Spectral OCT SLO, to aid in detecting ocular disease.