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.
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 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.
Dextenza is a bioabsorbable intracanalicular hydrogel plug that contains dexamethasone, fulfills an enormous unmet need for patients.
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 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.
Intracanalicular Punctal Plugs
Intracanalicular plugs, also known as punctal plugs, lacrimal plugs, or occluders, are small, absorbable polyethylene glycol hydrogel plugs that are used to deliver a sustained, therapeutic level of medication to targeted ocular tissue. The intracanalicular plug is designed to be absorbed, and exit the nasolacrimal system without need for removal by the physician. The plugs contain a visualization agent for retention monitoring throughout the treatment period.
Physicians typically use a topical or local anaesthetic prior to inserting a punctal plug. Each eyelid has one punctum, located at its inner margin near the nose. Punctal plugs can be inserted in the puncta of the lower lids, the upper lids or both. An instrument may be used to dilate the tear duct opening for easier insertion. Some punctal plugs are inserted just into the puncta so they still can be seen and mechanically removed if necessary. Other punctal plugs are inserted deeper into the canaliculus. These types of plugs, technically called intracanalicular plugs, do not protrude from the punctum. They are not visible or felt, and conform to the shape of the cavity. If removal is indicated, intracanalicular plugs are extracted by flushing them out. Once inserted, punctal plugs can last from several days to several months. Punctal plugs have been used for patients with a diagnosis of dry eye syndrome (DES) and keratoconjunctivitis sicca (KCS) for many years and are actively being investigated as a way to deliver medications (drug eluting) for the treatment of post-operative inflammation and pain, allergic and bacterial conjunctivitis, and for the treatment of glaucoma and ocular hypertension.
The potential risks associated with the use of intracanalicular plugs include transient discomfort after insertion, infection, canaliculitis, and migration further into the drainage canal or stenosis (narrowing) of the intracanalicular canal. When the plug unexpectedly migrates outside the target area and deeper into the eye’s drainage channels, this can create blockages leading to dacryocystitis which can cause inflammation of the nasolacrimal sac, infection with swelling, and pain and discomfort. Soft types of punctum plugs generally can be removed by flushing them out (irrigation). However, surgery might be needed when a punctum plug migrates into the eye drainage canal.
Potential advantages of ocular inserts over traditional ophthalmic preparations
• Increased ocular residence, hence, prolonged drug activity and higher bioavailability;
• Release of drugs at a slow, constant rate;
• Accurate dosing (insert contains a precise dose, which is fully retained at the administration site);
• Reduction of systemic absorption;
• Better patient compliance, due to reduced frequency of administration and less incidence of visual and systemic side-effects;
• Possibility of targeting internal ocular tissues through non-corneal (conjunctival scleral) routes;
• Increased shelf life with respect to aqueous solutions;
• Exclusion of preservatives, thus reducing the risk of sensitivity reactions;
• Incorporation of various novel chemical / technological approaches, such as pro-drugs, mucoadhesives, permeation enhancers, micro particulates, salts acting as a buffer.
Potential risks of ocular inserts can include
• Sensation of a foreign body in the eye, a physical and psychological barrier to patient compliance;
• Insert migration, making insert removal more difficult;
• Unintentional loss during sleep or from rubbing the eyes;
• Interference with vision.
Active ocular infections.
Warnings and Precautions: Dextenza
• Intraocular Pressure Increase: Monitor intraocular pressure.
• Bacterial Infections: Steroids may mask signs of infections and enhance existing infections.
• Viral Infections: Ocular steroids may prolong the course and exacerbate the severity of ocular viral infections.
• Fungal Infections: Consider fungal invasion in any persistent corneal ulceration.
• Delayed Healing: Ocular steroids may slow the rate of ocular healing.
Adverse Reactions: Dextenza
The most commonly reported adverse reactions were anterior chamber inflammation and elevations in intraocular pressure. These occurred in approximately 5-9% of patients.
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.
FDA approves Dextenza for treatment of postoperative eye discomfort
Dextenza (dexamethasone ocular inserts 0.4 mg) is the first FDA-approved intracanalicular insert (see notes below) to deliver dexamethasone in slow release quantities to deal with postoperative ocular pain for approximately thirty days with just one treatment.
Dextenza showed effectiveness in two randomized, vehicle-controlled stage 3 studies. A statistically significant number of patients that received Dextenza were without discomfort 8 days after cataract surgical procedure compared with patients in the vehicle control group. Furthermore, safety was shown in both phase 3 studies, in addition to a third randomized, vehicle-controlled phase 2 study. The phase 3 FDA trials revealed that Dextenza dramatically minimized pain and inflammation contrasted to the control group and also for the majority of patients obviated the need for a topical corticosteroid. The device delivers medicines right into the anterior segment for 3 to 4 weeks and may eliminate the need for topical steroids with attendant compliance and delivery issues.
Dextenza is a bioabsorbable intracanalicular hydrogel plug which contains dexamethasone, fulfilling an enormous unmet need for patients.
Medication delivery is a substantial challenge for several patients. They have difficulty instilling eye drops, as well as non-compliance is also a major problem in achieving tharapeutic results. Concerns with compliance, corneal infection, convenience, price and also cosmesis are amongst the factors to consider for new and better medication delivery techniques. There is virtually equal noncompliance among post-cataract clients, with the literature showing that 31% of cataract individuals had problem putting eyedrops, as well as 92% made use of improper methods for drop instillation. There is also a tremendous unmet need among cataract surgical procedure patients, who for psychological or physical factors cannot administer their medicines. These patients either go without their medications or call for the help of a relative to administer their eyedrops.
The approval of Dextenza is genuinely significant for two reasons. First, this liquifying hydrogel put in the lower lid punctum will allow doctors an entirely brand-new course for providing anti-inflammatory medicine adhering to surgical procedure – a path that calls for no drops and also aids rehabilitate the ocular surface while the eye heals. Second, a comparable hydrogel delivery system can be utilized for various other medications as well as various other problems, such as glaucoma, allergic reaction as well as even macular degeneration. To put it simply, with this approval the FDA is signalling approval of a really unique as well as really efficient platform that will transform drug delivery in ophthalmology.
Intracanalicular Punctal Plugs
Intracanalicular plugs, likewise called punctal plugs, lacrimal plugs, or occluders, are tiny, absorbable polyethylene glycol hydrogel plugs that are made use of to deliver a continual, therapeutic degree of medication to targeted eye tissue. The intracanalicular plug is designed to be absorbed, and leave the nasolacrimal system without requirement for removal by the medical professional. The plugs contain a visualization agent for retention tracking throughout the therapy period.
Physicians typically make use of a topical or local anaesthetic prior to inserting a punctal plug. Each eyelid has one punctum, located at its internal margin near the nose. Punctal plugs can be put in the puncta of the lower eyelids, the top eyelids or both. A device might be utilized to dilate the tear duct opening for less complicated insertion. Some punctal plugs are inserted simply right into the puncta so they still can be seen and mechanically gotten rid of, if necessary, when required. Other punctal plugs are placed deeper into the canaliculus. This sort of plugs, practically called intracanalicular plugs, do not stick out from the punctum. They are not noticeable or felt, as well as conform to the shape of the cavity. If removal is suggested, intracanalicular plugs are drawn out by flushing them out. When placed, punctal plugs can last from several days to numerous months. Punctal plugs have actually been utilized for people with a medical diagnosis of dry eye syndrome (DES) and also keratoconjunctivitis sicca (KCS) for many years and also are actively being seen as a means to provide medicines (drug eluting) for the therapy of post-operative swelling and also discomfort, sensitive and microbial conjunctivitis, as well as for the therapy of glaucoma as well as eye hypertension.
The potential risks connected with the use of intracanalicular plugs consist of transient discomfort after insertion, infection, canaliculitis, and also migration additionally right into the water drainage canal or stenosis (narrowing) of the intracanalicular canal. When the plug unexpectedly migrates outside the target area and also much deeper right into the eye’s drain channels, this can produce clogs resulting in dacryocystitis which can cause swelling of the nasolacrimal sac, infection with swelling, as well as discomfort and also pain. Soft kinds of punctum plugs normally can be gotten rid of by flushing them out (irrigation). Nonetheless, surgery may be needed when a punctum plug moves into the eye drain canal.
Potential benefits of eye inserts over traditional ophthalmic preparations
– Boosted eye residence, hence, extended medication activity and greater bioavailability;
– Delivery of medications at a slow, continuous price;
– Precise application (insert contains a specific dose, which is completely retained at the administration site);
– Reduction of systemic absorption;
– Much better patient conformity, as a result of lowered frequency of administration and also less occurrence of visual as well as systemic side-effects;
– Opportunity of targeting inner ocular cells through non-corneal (conjunctival scleral) routes;.
– Boosted service life with respect to aqueous solutions;
– Exclusion of chemicals, therefore lowering the threat of sensitivity responses;
– Incorporation of numerous novel chemical/ technological techniques, such as pro-drugs, muco-adhesives, permeation enhancers, micro particulates, salts working as a buffer.
Prospective threats of ocular inserts can consist of
– Sensation of a foreign body in the eye, a physical and emotional barrier to individual compliance;
– Insert migration, making insert elimination more difficult;
– Unintended loss throughout rest or from scrubbing the eyes;
– Disturbance with vision.
Active eye infections.
Warnings and Precautions: Dextenza
– Intraocular Pressure Boost: Monitor intraocular pressure
– Microbial Infections: Steroids may mask signs of infections as well as enhance existing infections
– Viral Infections: Eye steroids may lengthen the course as well as aggravate the extent of ocular viral infections
– Fungal Infections: Take into consideration fungal invasion in any type of persistent corneal ulceration
– Delayed Healing: Ocular steroids may slow down the rate of ocular recovery
Adverse Reactions: Dextenza.
Two of the most commonly reported adverse reactions were anterior chamber inflammation and elevations in intraocular pressure. These occurred in around 5%-9% of patients.
In conclusion, there is a considerable unmet need for ocular drug delivery that avoids difficulties connected with topical medicines, such as poor compliance, corneal infections, discomfort, expense as well as cosmesis. Provided the breadth of alternatives already offered or in advancement, drug delivery will unavoidably transform significantly over the next numerous years as well as the approval of Dextenza is a significant step in the right direction.