Perspective

FDA approves Dextenza for treatment of postoperative ocular pain

The FDA approved Dextenza for intracanalicular use for the treatment of ocular pain after ophthalmic surgery, Ocular Therapeutix announced in a press release.

Dextenza (dexamethasone ophthalmic insert 0.4 mg) is the first FDA-approved intracanalicular insert to deliver dexamethasone to treat postoperative ocular pain for up to 30 days with one treatment.

“We are extremely pleased to announce the approval of Dextenza, coming so soon after our preapproval inspection and approximately 1 month ahead of the PDUFA date,” Antony Mattessich, Ocular Therapeutix president and CEO, said in the release.

Dextenza demonstrated efficacy in two randomized, vehicle-controlled phase 3 studies. A statistically significant number of patients who received Dextenza were free of pain 8 days after cataract surgery compared with patients in the vehicle control group. In addition, safety was demonstrated in the two phase 3 studies, as well as a third randomized, vehicle-controlled phase 2 study, the release said.

Ocular Therapeutix applied for transitional pass-through payment status and intends to apply for a J-code before the January 2019 deadline.

 

The FDA approved Dextenza for intracanalicular use for the treatment of ocular pain after ophthalmic surgery, Ocular Therapeutix announced in a press release.

Dextenza (dexamethasone ophthalmic insert 0.4 mg) is the first FDA-approved intracanalicular insert to deliver dexamethasone to treat postoperative ocular pain for up to 30 days with one treatment.

“We are extremely pleased to announce the approval of Dextenza, coming so soon after our preapproval inspection and approximately 1 month ahead of the PDUFA date,” Antony Mattessich, Ocular Therapeutix president and CEO, said in the release.

Dextenza demonstrated efficacy in two randomized, vehicle-controlled phase 3 studies. A statistically significant number of patients who received Dextenza were free of pain 8 days after cataract surgery compared with patients in the vehicle control group. In addition, safety was demonstrated in the two phase 3 studies, as well as a third randomized, vehicle-controlled phase 2 study, the release said.

Ocular Therapeutix applied for transitional pass-through payment status and intends to apply for a J-code before the January 2019 deadline.

 

    Perspective
    Eric D. Donnenfeld

    Eric D. Donnenfeld

    Drug delivery is a significant challenge for many patients. They have difficulty instilling eye drops, and noncompliance becomes a major challenge in achieving therapeutic results. Issues with compliance, corneal toxicity, comfort, cost and cosmesis are among the reasons for consideration of new and better drug delivery methods. There is almost equal noncompliance among post-cataract patients, with the literature showing that 31% of cataract patients had difficulty inserting drops, and 92% used improper techniques for drop instillation.  There is also a tremendous unmet need among cataract surgery patients, who for emotional or physical reasons cannot administer their medications. These patients either go without their medications or require the aid of a family member to apply their drops.

    The recent FDA approval of Ocular Therapeutix’ Dextenza, a bioabsorbable intracanalicular hydrogel plug that contains dexamethasone, fulfills an enormous unmet need for patients. The phase 3 FDA trials showed that Dextenza significantly reduced pain and inflammation compared to the control group and eliminated for the great majority of patients the need for a topical corticosteroid. The device releases drugs into the anterior segment for 3 to 4 weeks and may obviate the need for topical steroids.

    In conclusion, there is a significant unmet need for ophthalmic drug delivery that avoids challenges associated with topical medications, such as poor compliance, corneal toxicity, discomfort, cost and cosmesis. Given the breadth of options already available or in development, drug delivery will inevitably change greatly over the next several years and the approval of Dextenza is a major step in the right direction.

     

    Reference:

    An JA, et al. J Cataract Refract Surg. 2014;doi:10.1016/j.jcrs.2014.02.037.

    • Eric D. Donnenfeld, MD
    • OSN Cornea/External Disease Board Member

    Disclosures: Donnenfeld reports he is a consultant for Allergan, Mati Pharmaceuticals, EyePoint Pharmaceuticals, Ocular Therapeutics and Omeros.

    Perspective
    John A. Hovanesian

    John A. Hovanesian

    The approval of Dextenza is truly significant for two reasons. First, this dissolving hydrogel placed in the lower lid punctum will allow surgeons a completely new route for delivering anti-inflammatory medication following surgery — a route that requires no drops and helps rehabilitate the ocular surface while the eye heals. Second, a similar hydrogel delivery system can be used for other drugs and other conditions, such as glaucoma, allergy and even macular degeneration. In other words, with this approval the FDA is signaling acceptance of a very novel and very effective platform that will change drug delivery in our specialty.

    • John A. Hovanesian, MD, FACS
    • OSN Cataract Surgery Section Editor

    Disclosures: Hovanesian reports he is a stockholder in and consultant for Ocular Therapeutix.