FDA approves Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular pain following ophthalmic surgery

Ocular Therapeutix™, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, recently announced that the U.S. Food and Drug Administration (FDA) has approved Dextenza (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery.

“We are extremely pleased to announce the approval of Dextenza, coming so soon after our pre-approval inspection and approximately one month ahead of the PDUFA date,” said Antony Mattessich, the Company’s President and Chief Executive Officer. “Just over a year ago, we set out to augment our scientific and formulation expertise with individuals who have the skills and experience to create a first-class team to get Dextenza approved and become a commercial stage biopharmaceutical company.

We believe this approval is a major external validation of the drug delivery technology platform, and also of the transformation that has taken place at Ocular. While we are excited by the approval of our first drug product, our goal has always been to bring Dextenza to as many patients as possible in the near term and to revolutionize ophthalmic drug delivery by making drops obsolete. We now turn our efforts towards the successful commercial launch of Dextenza.”

Dextenza is the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration.

The approval of Dextenza was based on (i) demonstrated efficacy in two randomized, vehicle-controlled Phase 3 studies in which a statistically significantly higher incidence of subjects were pain free at day 8 post-cataract surgery compared to the vehicle control group and (ii) safety in the two Phase 3 studies as well as a third randomized, vehicle-controlled Phase 2 study.

The Company believes the delivery profile represents a differentiated and potentially transformational new product for patients and physicians. For patients, Dextenza offers the convenience of a full course of post-surgical steroid treatment with a physician’s one-time placement of a single intracanalicular insert. Dextenza has the potential to replace a complex eye drop regimen that under the current standard of care requires up to 70 topical ocular steroid drops.

“Compliance with taking eye drops after eye surgery is very challenging for patients and a concern for surgeons,” said Michael Goldstein, MD, Chief Medical Officer. “The approval of Dextenza offers surgeons the opportunity to treat patients with a preservative-free steroid after surgery with the placement of a single drug insert. With this product, patients may be liberated from having to deal with the burdensome regimen of using steroid eye drops after ophthalmic surgery.”

Dextenza Label

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery.

Dextenza is a preservative-free ophthalmic insert that is inserted in the lower lacrimal punctum and into the canaliculus. A single Dextenza releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion.

Dextenza is resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert if necessary. Dextenza is intended for single-use only.

Dextenza was studied in two randomized, multicenter, double-masked, parallel group, vehicle-controlled Phase 3 clinical trials, with patients receiving Dextenza or its vehicle immediately upon completion of cataract surgery. In Study 1, 80% of Dextenza-treated patients (n=164) were pain-free at Day 8 compared to 43% of vehicle-treated patients (n=83) (p<0.0001). In Study 2, 77% of Dextenza-treated patients (n=161) were pain-free at Day 8 compared to 59% of vehicle-treated patients (n=80) (p=0.025).

Safety was assessed from the two Phase 3 clinical trials and a Phase 2 clinical trial. Overall, 351 subjects were exposed to Dextenza. The most common ocular adverse reactions in subjects treated with Dextenza were: anterior chamber inflammation including iritis and iridocyclitis (9%), increased intraocular pressure (5%), reduced visual acuity (2%), eye pain (1%), cystoid macular edema (1%), corneal edema (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

Dextenza important safety information

Dextenza is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infections; fungal diseases of the eye; and dacryocystitis.

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma and intraocular pressure should be monitored during treatment.

Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.

Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Therapeutix™, Inc.

 

FDA approves Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular pain following ophthalmic surgery

Ocular Therapeutix, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, recently announced that the U.S. Food and Drug Administration (FDA) has approved Dextenza (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery. We are extremely pleased to announce the approval of Dextenza, coming so soon after our pre-approval inspection and approximately one month ahead of the PDUFA date, said Antony Mattessich, the Companys President and Chief Executive Officer. Just over a year ago, we set out to augment our scientific and formulation expertise with individuals who have the skills and experience to create a first-class team to get Dextenza approved and become a commercial stage biopharmaceutical company. We believe this approval is a major external validation of the drug delivery technology platform, and also of the transformation that has taken place at Ocular. While we are excited by the approval of our first drug product, our goal has always been to bring Dextenza to as many patients as possible in the near term and to revolutionize ophthalmic drug delivery by making drops obsolete. We now turn our efforts towards the successful commercial launch of Dextenza. Dextenza is the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration. The approval of Dextenza was based on (i) demonstrated efficacy in two randomized, vehicle-controlled Phase 3 studies in which a statistically significantly higher incidence of subjects were pain free at day 8 post-cataract surgery compared to the vehicle control group and (ii) safety in the two Phase 3 studies as well as a third randomized, vehicle-controlled Phase 2 study. The Company believes the delivery profile represents a differentiated and potentially transformational new product for patients and physicians. For patients, Dextenza offers the convenience of a full course of post-surgical steroid treatment with a physicians one-time placement of a single intracanalicular insert. Dextenza has the potential to replace a complex eye drop regimen that under the current standard of care requires up to 70 topical ocular steroid drops. Compliance with taking eye drops after eye surgery is very challenging for patients and a concern for surgeons, said Michael Goldstein, MD, Chief Medical Officer. The approval of Dextenza offers surgeons the opportunity to treat patients with a preservative-free steroid after surgery with the placement of a single drug insert. With this product, patients may be liberated from having to deal with the burdensome regimen of using steroid eye drops after ophthalmic surgery. Dextenza Label Dextenza (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery. Dextenza is a preservative-free ophthalmic insert that is inserted in the lower lacrimal punctum and into the canaliculus. A single Dextenza releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. Dextenza is resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert if necessary. Dextenza is intended for single-use only. Dextenza was studied in two randomized, multicenter, double-masked, parallel group, vehicle-controlled Phase 3 clinical trials, with patients receiving Dextenza or its vehicle immediately upon completion of cataract surgery. In Study 1, 80% of Dextenza-treated patients (n=164) were pain-free at Day 8 compared to 43% of vehicle-treated patients (n=83) (p0.0001). In Study 2, 77% of Dextenza-treated patients (n=161) were pain-free at Day 8 compared to 59% of vehicle-treated patients (n=80) (p=0.025). Safety was assessed from the two Phase 3 clinical trials and a Phase 2 clinical trial. Overall, 351 subjects were exposed to Dextenza. The most common ocular adverse reactions in subjects treated with Dextenza were: anterior chamber inflammation including iritis and iridocyclitis (9%), increased intraocular pressure (5%), reduced visual acuity (2%), eye pain (1%), cystoid macular edema (1%), corneal edema (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%). Dextenza important safety information Dextenza is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infections; fungal diseases of the eye; and dacryocystitis. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma and intraocular pressure should be monitored during treatment. Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Therapeutix, Inc.