Greetings from Pennsylvania where it is 90°F in the shade. I was just puppy lifeguarding for about an hour. Now they are sleeping. All that swimming and fighting with your sister is tough on a puppygirl!
Speaking of the weather, I need to remind you, if you are having a heat wave like we are, please make sure you are drinking enough. Be sure you are able to get to someplace cool. This is especially true if the power goes out and your air conditioning goes off. People die of the heat every year.
I should be doing other things; I know. I’m not. Having four days a week off takes away a lot of the urgency. Besides, I would have to go inside to use the CCTV or to clean and I don’t want to go in. I am one of those weird people who loves this weather.
So you are stuck with me and a hodgepodge of news. First of all, I discovered they published the ‘official’ lampalizumab results in JAMA Ophthalmology this month. It is still June, so, yes, this month. Of course, the bottom line has not changed: it did not work. They are perplexed as to why they found an interaction between a certain genotype and the treatment when they ran the phase 2 data. It was not there when they ran larger numbers in phase 3.
Of course, the researchers are still crunching data. They are also planning on running whole genome sequences on the subjects to see if their genetic make-ups shed any light on what went wrong. Maybe suggest some new use for “lamp stuff”. Not to be too cynical about this, but this treatment cost plenty to develop and was supposed to be an amazing cash cow for Roche. Might as well see if there is a use for it somewhere.
I found a plan for a research review published by staff in the genetic medicine department at Newcastle University. They are planning to gather all the research they can find on photobiomodulation and dry AMD and see what they discover. This might be the first salvo in a battle to get the Lumithera machine approved in the UK.
Apparently, they are not sure exactly how the thing works. The section on the science behind it is headed “How the intervention might work.” (I always like magic myself!?) What they think is there is some sort of interaction with the mitochondrial that leads to a reduction of oxidative stress. Maybe. Like I said, magic.
I am not finding an end date for their research review and meta-analysis. I cannot, however, believe it will be too long. Maybe a year or so. Maybe more.
Coming across “the pond” I found an article about Lumithera presenting at ARVO in Seattle. The research LIGHTSITE 1 is promising.
I then went to clinical trials.gov and found a 2017 study that was identified as phase “not applicable”. Ok. Considering we are all lifetime learners… I found a flowchart on how to identify a device that would be applicable for a clinical trial but I did not get very far. Either the government’s verbiage is obtuse or I am. Suffice it to say, it has something to do with not requiring phases. Why? You are actually asking ME?!?!
Anyway, the 2017 research ran an ‘n’ [number of participants] of something like 30. Pretty small. Not sure if that will be good enough for the FDA even with all the European data. You people with early stage AMD, keep your eyes open. This one just may be for you!
Written 6/30/2018