This warning was just sent out today to retinal specialists and when they read it they may be more cautious or even have other cases of inflammation that they did not report. So chances are, other cases will be reported soon. I personally have not used Eylea yet because I wanted to wait several months to see how things go with it and it is still very expensive and might last a little longer than Avastin.
Dear ASRS Member:
Last week, the ASRS was notified by members of a number of reported cases of ocular inflammation/non-infectious endophthalmitis following intravitreal injection of aflibercept (Eylea) for the treatment of neovascular AMD. I have personally contacted treating physicians to confirm clinical details of these reports and have had multiple conversations with leadership at Regeneron. The ASRS has also been in contact with representatives of several large practices to determine if additional unreported cases exist. To date, the ASRS has not identified any other cases other than those reported to the manufacturer.
Attached is a letter to the FDA from Regeneron which will be sent as part of the scheduled 90-day post-marketing surveillance report following the launch of aflibercept in November 2011. Regeneron's letter will be disclosed today as part of a Securities and Exchange Commission (SEC) presentation to investors and contains a review of the pertinent literature. I believe that this report is accurate and represents an open disclosure of all known events to date. Regeneron voluntarily released this letter to the ASRS (yesterday evening) prior to its public release today. I am appreciative of the candor and transparency of our interactions regarding this sensitive issue.
As detailed within, there have been 14 cases to date reported in Connecticut, New Jersey, and Florida since product launch in November 2011. Since that time, an estimated 35,000 vials have shipped with an estimated 30,000 injections given (0.047%). A cluster of cases occurred in a single practice with 7 occurring initially and an additional 4 cases subsequently. Cases occurred primarily from a single physician in this retina-only practice, from different medication lots, using the physician's standard intravitreal injection protocol. The manufacturer's syringe was used with a 32g needle. Lidocaine gel was used for topical anesthesia.
All cases presented with a clinical presentation similar to other reported case series of non-infectious (culture-negative) endophthalmitis. Each treating physician used his or her practice's standard intravitreal injection protocol. All medication kits supplied by the manufacturer were identical to those used in the pre-market VIEW 1 and VIEW 2 phase III clinical trials. Patients have presented with mild to moderate discomfort, blurred vision, vitritis, and mild to moderate anterior segment inflammation. One of 14 presented with a micro-hypopyon visible only by gonioscopy. Two of 14 presented with corneal edema, each had sub-conjunctival lidocaine. Patients who received a diagnostic tap were culture negative. All patients responded to antibiotic and anti-inflammatory treatment. Each treating physician has communicated findings to the manufacture. Regeneron has reported that extensive testing of recalled medication failed to reveal any irregularities.
The pathogenesis of rare events is difficult to elucidate. The ASRS applauds the treating physicians' and manufacturer's openness in sharing information during this inquiry. I have asked that the Research and Therapeutics Committee form a Therapeutic Surveillance sub-committee to help investigate these rare events. This will be particularly useful as new drugs and technologies emerge. This report serves to heighten awareness of this clinical event. At present, these cases appear to be congruent with published reports of NIE following intravitreal injection. However, I most strongly urge that members continue to monitor for adverse events of all treatments and to report unexpected events to the manufacturer, to Med Watch (an anonymous service of the FDA), and to the ASRS.
Suber S. Huang, MD, MBA
President, American Society of Retina Specialists
The "news" you are referring to doesn't in my opinion explain a 20% pop out of the blue, on a down day for the markets. Often these moves in small cap stocks precede the more public "news".
I'm assuming you have been short since October 28, 2009 when you made your first post. That means you're in at 28.91 dividend adjusted and you're feeling the pain. Can't you just admit that you're under water, or do you really want us to believe that you have covered your short and are here to edify us?
That would be a nice addition to the iphone since it doesn't work very well for navigation, but the built in maps would add another layer of cost that I doubt will be efficient for the average consumer. But, nice try.
TomTom's sales must be miserable low since their highest selling electronics item on Amazon comes in at #59 and Garmin has 4 units in the top twenty. In addition, Garmin is a way more diversified company with it's fitness, marine, and aviation units.
I just replaced the nuvifone with the iphone and also got the Garmin Streetpilot. For $35 it works pretty darn well. The only thing that is missing is the complete maps so you really can't zoom in-out extensively and explore parts of the map outside of your route. The traffic seemed to work pretty accurately and the lane assist is great when coming up to interstate interchanges. I ordered a windshield mount and I'm hoping that works out as well as the nuvifone since that was one of it's best features.
The 3 month chart should be put in a traders manual as a perfect example of a chart that screams sell. I've rarely seen such perfection. Again, ask yourself, what is more likely in the coming couple weeks, $70 or $90?