US FDA approves Sun Pharma’s Cequa to treat dry eye disease

By Maggie Lynch contact

- Last updated on GMT

(Image:Getty/eternalcreative)
(Image:Getty/eternalcreative)

Related tags: Ophthalmology, Fda, FDA approval

The FDA has approved Sun Pharma’s Cequa for the treatment of 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. 

Related news

Related products

show more

From Candidate to Clinic- European Capabilities

From Candidate to Clinic- European Capabilities

Catalent Pharma Solutions | 22-Oct-2018 | Technical / White Paper

Catalent’s Nottingham, UK facility focuses on early stage development of small molecule drug candidates from the bench to clinic. This facility offers...

Fill Release at the Right Time in the Right Place

Fill Release at the Right Time in the Right Place

Gelita AG | 19-Sep-2018 | Technical / White Paper

From rapid release in the stomach for e.g. analgesics to enteric release for fills with unpleasant aftertaste – GELITA delivers the respective gelatine...

Strategies to Select and Deliver the Right Candidate

Strategies to Select and Deliver the Right Candidate

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

Does your candidate have what it takes to succeed? Do you have the information needed to make the right decisions about your candidate’s path to the clinic?...

Related suppliers

Follow us

Products

View more