US FDA approves Sun Pharma’s Cequa to treat dry eye disease
Cequa (cyclosporine ophthalmic solution) is now a US Food and Drug Administration (FDA) approved treatment option for dry eye disease sufferers. The treatment is indicated to increase tear production through its highly concentrated formulation.
The treatment provides the highest concentration of cyclosporine A (CsA) currently approved by the FDA. It is the first and only CsA product that includes nanomicellar technology.
Nanomicellar technology incorporates micelles, which are gelatinous aggregates of amphipathic molecules that are small enough to enter into corneal and conjunctival cells, thereby enabling delivery of high concentrations of CsA.
This technology allows for increased solubility and can penetrate the eyes aqueous layer, preventing the release of active lipophilic molecule prior to this.
In a Phase III confirmatory trial, Cequa showed a significant improvement of participants Schirmers score, a quantitative measurement of tear production, the primary endpoint. Additionally, participants showed improvement of the secondary endpoint, ocular staining assessments, within one month.
Cequa will be commercialized in the US by Sun Ophthalmics, a division of Sun Pharma.
A Sun Pharma Spokesperson told us that its existing sales force, which is marketing its current portfolio of ophthalmic products in the US, will help market Cequa but the company is enlarging its sales force to ensure more promotion. The drug is expected to be launched anytime between October and March of next year.
