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US FDA issues draft norms for difluprednate, an ophthalmic emulsion to treat eye swelling and pain
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Nandita Vijay, Bengaluru
February 28 , 2017
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The US FDA has issued a draft guidance for the active ingredient
difluprednate which is an ophthalmic emulsion with a strength of 0.05
per cent. The drug is categorised under corticosteroids and works to
stall the release of certain natural substances that cause swelling and
pain. The drug which is used for eye surgery has the regulatory
authority insisting on data of a comparative study which should be
performed on at least three exhibit lots of both test and reference
products.
In order to determine the strength of the product, the
regulator has recommended two options: in vitro or in vivo study.
Firstly, the manufacturer will need to qualify for the in vitro option
for this drug product. It should ensure that the test and Reference
Listed Drug (RLD) formulations are qualitatively and quantitatively the
same.
Secondly, it is the acceptable comparative physicochemical
characterization of the test and RLD formulations. The comparative study
needs to be conducted of both test and reference products.
The
regulator has also fixed parameters to measure the globule size
distribution, viscosity profile as a function of applied shear, pH, zeta
potential, osmolality, and surface tension. Sponsors should also submit
information on the drug distribution in different phases within the
formulation.
Population bioequivalence (PBE) is recommended in
the case of globule size distribution. The other parameters do not
require PBE analysis. The applicants should provide not less than 10
data sets from 3 batches with each of the test and reference products to
be used in the PBE analysis. Sponsors should compare the size parameter
upon serial dilution of the test and reference products, and provide
histograms of size distribution data of each diluted sample, stated the
regulatory note.
Under in-vivo option, the regulator recommends
one bioequivalence study with pharmacokinetic (PK) endpoint. The
subjects for this study should be patients undergoing indicated cataract
surgery. In addition, the regulator calls to submit metabolite data as
supportive evidence of therapeutic outcome.
According to the
government ophthalmic care majors like MintoEye Hospital, affiliated to
the Bangalore Medical College and Research Institute, the drug
difluprednate is a corticosteroid and is approved for the treatment of
post-operative ocular inflammation and pain. “There are efforts to
extend its use for other ocular inflammatory diseases which are on the
rise. Therefore, there is need for constant update on clinical efficacy
and adverse drug reactions.”
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