The health care system is increasingly stressed with the aging of the population and the disproportionate impact of disease processes on older patients. This coincides with a general trend in medicine to seek the least invasive treatment possible for the benefit of the patient. Whenever possible, it is preferable to avoid surgery and the resulting trauma to the patient as well as the tremendous demand for manpower on the health care system. One such breakthrough for the treatment of vitreomacular adhesion (VMA) and associated macular hole appears to have been identified. Julia A. Haller, MD, and colleagues recently published results of 2 studies in the New England Journal of Medicine that represent an enormous advance and possible shift in the treatment paradigm. Retina Today had the opportunity to speak with Dr. Haller about the studies and VMA in general.

Retina Today: Can you provide an overview of your study?

Julia A. Haller, MD: My colleagues and I reported the results of 2 multicenter, randomized, double-blind, phase 3 clinical trials, treating a total of 652 eyes with VMA.1 A single injection of 125 μg of ocriplasmin (Jetrea, Thrombogenics) was administered in 464 eyes, and the remaining 188 eyes received a placebo injection.

At the 28-day primary endpoint, VMA resolved in 26.5% of ocriplasmin-injected eyes, compared with 10.1% of placebo-injected eyes (P < .001). Total posterior vitreous detachment was achieved in 13.4% of ocriplasmininjected eyes compared with 3.7% of the control group (P < .001), and nonsurgical closure of macular holes was achieved in 40.6% of ocriplasmin-injected eyes, compared with 10.6% of placebo-injected eyes (P < .001). Best-corrected visual acuity gains of 3 or more lines were seen in 12.3% of ocriplasmin-injected eyes compared with 6.4% of placebo-injected eyes (P < .001).

Most of the adverse events were transient and mild in severity, such as vitreous floaters, photopsia, injection- related eye pain, and conjunctival hemorrhage. The majority of adverse events occurred within the first 7 days after treatment, with an overall occurrence of 68.4% in the ocriplasmin group and 53.5% in the placebo group (P = .26). The difference between the groups is primarily due to events known to be associated with vitreous detachment.

RT: How do you define symptomatic VMA?

Dr. Haller: Everyone's vitreous gel gradually peels away from their retina as they age. In many individuals, there are moments when the gel adheres to and tugs on the macular area of the retina. This occurrence is called VMA traction. Symptomatic VMA is when the patients experience distortion or metamorphopsia, which means that when they look at something, it's distorted almost like a fun house mirror. Objects tend to curve and bow in, and patients may find they are having trouble reading signs. They no longer read for pleasure, they can't make out the newspaper, and they have to enlarge everything on their handheld device in order to be able to read it.

I saw a patient with this today who has normal peripheral vision and on a reading chart, she can actually make it down to 20/50, which is still good enough to get a driver's license. However, she can't go down steps anymore because her depth perception has deteriorated so badly that she has trouble putting one foot in front of the other. She literally can't navigate out in the world without being afraid that she is going to slip and fall. Patients with VMA can be very symptomatic and still be able to somehow make their way down an eye chart in the doctor's office fairly well.

RT: How do you feel this study will have an effect the treatment of symptomatic VMA?

Dr. Haller: The US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic VMA. When it receives final approval, it has the potential to be a real game changer for retina surgeons and their patients because it provides a nonsurgical option for patients who have VMA that is causing symptoms. Someone who sees 20/40 would not normally be considered a surgical candidate, but now there is an option for treating the disease process at an earlier stage before permanent damage occurs, and that is very exciting.

The real homerun here is with patients with macular holes. Nonsurgical closure of a macular hole by day 28 was achieved in 40.6% of ocriplasmin-injected eyes, as compared with 10.6% of placebo-injected eyes. The ability to resolve macular holes with a simple in-office injection is huge. The alternative for patients is a vitrectomy, which requires having a gas bubble put in their eye, keeping their head down, and being followed by the doctor for weeks until the gas bubble finally goes away. Normal activity and work have to be suspended from days to weeks.

RT: What is the potential economic impact of ocriplasmin?

Dr. Haller: Ocriplasmin has the potential to have a tremendous positive economic impact on the individual patient, his or her family, and the health care system. The patient has to take time off from work and enlist help from family and friends for care and transportation perioperatively, particularly if they have a gas bubble. A surgical procedure requires postoperative visits, ocular drops, and all of the paraphernalia to aid in keeping the patient's head down. There is a significant amount of lost work time associated with surgery and recuperation.

The health care system is increasingly stressed with the aging of the population, and the disease processes of VMA affect older patients disproportionately. The ability to treat a lot of those patients with an in-office injection and not having to tie up ORs and offices would help decrease these burdens.

Ophthalmology has changed significantly in the last decade due to the widespread adoption of optical coherence tomography. The improvements in optical imaging have allowed us to increase our understanding of the eye by leaps and bounds, and VMA is one of those areas that have come into awareness recently. Now that we have better characterized this pathology and found new options for its treatment, the next step is to increase awareness among the general medical and ophthalmic communities. It is now even more crucial than ever for individuals to know that if they have central visual distortion or decreased acuity, it is important to be evaluated, because they may have a very treatable disease.

Julia A. Haller, MD, is Professor and Chair of Ophthalmology at Thomas Jefferson University and Thomas Jefferson University Hospital. She is also Ophthalmologist-in-Chief at Wills Eye Institute. Dr. Haller is a member of the Retina Today Editorial Board. She may be reached at +1 215 928 3000.

  1. Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606-615.