Our most advanced product candidate, DEXTENZA™, incorporates the FDA-approved corticosteroid dexamethasone as an active pharmaceutical ingredient into a hydrogel-based drug-eluting inctracanalicular depot. DEXTENZA is in Phase 3 clinical development for the treatment of post-surgical ocular inflammation and pain. In September 2015, we submitted to the FDA a New Drug Application, or NDA, for DEXTENZA for the treatment of post-surgical ocular pain. The FDA has accepted the NDA for filing and established a target action date under the Prescription Drug User Fee Act, or PDUFA, of July 24, 2016.
Inserted non-invasively through the punctum, DEXTENZA resides within the canaliculus, delivering a four-week tapered release of corticosteroid to the ocular surface. The product also contains a visualization aid for retention monitoring throughout the treatment period. After therapy is complete, the hydrogel resorbs and exits the nasolacrimal system without need for removal by the physician. DEXTENZA provides a dropless option for steroid therapy.
A Phase 2 study was conducted to evaluate the safety and efficacy of the DEXTENZA (OTX-DP) after cataract extraction with intraocular lens implantation. The DEXTENZA group demonstrated superiority over placebo (PVPP) for absence of anterior chamber cells at days 14 and 30 (p<0.005), and was superior to placebo for absence of pain at all time points (p<0.005) (see figures below). The DEXTENZA group demonstrated 100% retention through day 14, and 97% through day 30. No long-term spikes in IOP were observed.
Additionally, substantially more placebo subjects were prescribed rescue medication (72.4%) compared to the dexamethasone treated subjects (20.7%) at days 14 and 30. 43.3% of patients in the placebo group experienced adverse events in the study eye, compared to only 13.8% in the DEXTENZA group. The placebo group also experienced more corneal edema, photophobia and bulbar conjunctival injection. DEXTENZA exhibited a 97% retention rate through day 30.
About Post-operative Inflammation
Post-operative inflammation is a common side effect following any ophthalmic surgery. Due to this, physicians prescribe anti-inflammatories, such as corticosteroids, following ocular surgery as the standard of care. This not only helps manage the symptom, but also provides faster recovery for the patient. Approximately 8.5 million corticosteroid prescriptions were filled in 2014.1 Although corticosteroids are beneficial for treatment of post-surgical inflammation, some steroid regimens may cause spikes in intraocular pressure, which may lead to drug-induced glaucoma.
Steroid-loaded intracanalicular depots may be able to treat post-operative inflammation without causing spikes in intraocular pressure. Additionally, the one-time administration may improve compliance and convenience, resulting in better disease control.
About Allergic Conjunctivitis
When eyes are exposed to allergens, histamine is released and the blood vessels in the conjunctiva swell, making the eyes itch, tear and redden. Antihistamine or anti-inflammatory drops are often prescribed to relieve discomfort. Topical steroid drops, which prevent certain white blood cells from releasing histamine, are prescribed for more severe cases. These drops are sometimes prescribed in conjunction with antihistamines and work best if taken prior to coming into contact with the allergen. Approximately 6.9 million anti-allergy prescriptions, consisting of anti-histamines, mast-cell stabilizers and corticosteriods, were prescribed in 2014.1
Steroid-loaded intracanalicular depots may be able to treat the side effects associated with allergic conjunctivitis by eliminating self-administered drops and providing consistent relief to the ocular surface.
About Dry Eye
Dry eye disease affects the ocular surface and is characterized by dryness, inflammation, pain, discomfort, and irritation. Dry eye is a complex, multifactorial disease which can present differently in patients, and becomes more common with age. Due to the prevalence of the disease, well over one billion dollars are spent on treatment of the disease each year in the United States alone (IMS Health, 2014). One cause of the disease is inflammation of the ocular surface resulting from a patient’s immune response. Although physicians may prescribe topical steroid eye drops for the treatment of dry eye disease, chronic use of topical steroids can lead to elevations in intraocular pressure, which is a risk factor for glaucoma. Conversely, patients often do not reliably self-administer these drops, which can lead to eye irritation and continual, if not more, inflammation.