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FDA panel recommends approval of ocriplasmin for vitreomacular adhesion
In a unanimous decision yesterday, the U.S. Food and Drug Administration’s Dermatologic and Ophthalmic Drugs Advisory Committee recommended approval of a 125-µg dose of ThromboGenics’ ocriplasmin for the treatment of vitreomacular adhesion.
The biologics license application for ocriplasmin was based on two phase 3 trials in 652 eyes with a follow-up of 6 months. Vitreomacular adhesion resolution was observed as early as 7 days, and nonsurgical macular hole closure was seen at 28 days.
The committee voted 7 to 3 in agreement that 125 µg ocriplasmin is an effective treatment for macular hole associated with vitreomacular adhesion.
Committee members voted 1 to 8, with one abstention, that more evidence is necessary to determine whether ocriplasmin is an effective treatment for macular hole regardless of adhesion. The sponsor was not seeking approval for this indication. Members also voted that further studies should be performed to determine the drug’s effect on the retina.
Questions arose about the potential for vision loss associated with the use of ocriplasmin.
Discussing the benefits and risks of ocriplasmin on behalf of ThromboGenics, Julia Haller, MD, said that “ocriplasmin has an unequivocal benefit in one in four patients.”
“Remember, [vitrectomy] will leave you with worse vision than ocriplasmin will at 6 months," Haller said.
“Ocriplasmin, administered in the office setting, could revolutionize how we treat vitreomacular adhesion," Elias Reichel, MD, said during the public comment session.
The panelists offered no clear recommendations on the subject of labeling ocriplasmin.
Perspective
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Most importantly for our patients, now we will have an option, where none existed, for patients with symptomatic vitreomacular adhesion. Before we would have to watch these patients and hope that they could either get better or if they got worse you would give them a vitrectomy; now we can do an in-office procedure that really offers a very high chance of success, and if it doesn’t work it’s the safety is excellent, so we can go on to vitrectomy thereafter, if it doesn’t work.
One of the questions that the agency had and was being posed to the advisory committee was the idea that there are patients who are losing vision and why was that, either acutely or at the end of the study. When we looked at it, the patients who were losing vision acutely was due to the fact that the drug was working. It was peeling hyaloid off the retina and this was causing either subretinal fluid or submacular edema. As the vitreous was released, though, the subretinal fluid was removed and vision improved. So, it is kind of a pharmacologic vitrectomy where we are peeling the hyaloid off the retinal surface and this causes some vision changes. Then at the end of the study there were patients who lost vision, but it wasn’t due to the fact that there was an issue with the drug, it was because the patient had the vitreomacular traction and macular hole and these things were progressing, but in the study that was only 2% of patients.
I think that the key aspect is that, both in the patients with vitreomacular traction without holes and particularly in the patients who have holes, these are patients who now won’t need surgery and will not need the gas bubble. It is just a huge plus for patients as well as physicians who are all very excited that the vote today was unanimous and we look forward to seeing approval in short order.