Biotech Values

[mouton29]

Re: OCUL, sustained release prostaglandin. In the beagle study for Durysta (Allergan’s approved version), they compared tissue concentrations for topical v. sustained released for various tissues, and for the cornea, the ratio was not as high as for the iris-cilliary body but still astronomical — about 1000x. https://www.liebertpub.com/doi/epdf/10.1089/jop.2018.0067

But I don’t understand the clinical significance of this. For example, one side effect of topical prostaglandin drops is a change in iris color, estimated to occur in at least 10%, maybe 20%, of patients. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1771317/

In the Durysta phase 3, they reported iris color change in less than 3% of patients, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8602154/, yet the concentration of the drug in the iris is 4400x. So clearly side effects don’t necessarily follow from an increase in concentration.

Prostaglandins are strange drugs. E.g., dosing is once daily and studies show that twice daily dosing can be worse than ineffective, it may result in reduced efficacy.

You would think that this is something OCUL management would have considered. But I certainly don’t know for sure and they might just figure it’s worth a try.