Point/Counter

Is there still a future for postoperative topical steroid drops?

Click here to read the Cover Story, "New steroid options allow surgeons to better tailor postoperative treatment."

POINT

Always room for drops

Changes in post-cataract surgery steroid delivery have garnered significant attention in recent years. Traditionally, patients have been forced to use steroid drops several times per day for several weeks to control postop inflammation. Unfortunately, this can be difficult for many patients. Often, these patients are elderly and not capable of placing drops several times per day. This can place a burden on family members to ensure that the drops are delivered. This may also lead to poor compliance, which may then lead to complications and poor outcomes. In addition, the cost of these drops may cause another barrier to the patient.

In recent years, there have been numerous new preparations of steroid drops, as well as new avenues for drug delivery. Some of the newer formulations may allow a patient to use the drops at a much lower frequency, which certainly can improve compliance and decrease the lifestyle burden of frequent drops. The problem with these, just as with any new medication, is cost. Many insurance companies do not allow newer formulations of drugs that already exist in other forms, and the cost may be significantly higher.

Kenneth A. Beckman, MD, FACS
Kenneth A. Beckman

With the advent of intraoperative deposition of steroids, whether in the canaliculus or intraocularly, we may be able to eliminate the postoperative drop regimen entirely. While this would be ideal for the patient, there are barriers to this regimen as well. First, there is the cost to the surgery center. The cost of the drug comes out of the facility payment, and there needs to be an adequate reimbursement formula for the center to allow this to be done. Second, the deposited medication may not be reversible. If an intraocular deposition of a steroid is causing a complication, such as high pressure, the problem cannot be treated by stopping the medication. Third, but most importantly, the drugs need to be safe and efficacious. So far, it appears that they are. Physicians and patients need to be certain that the medication will work and do no harm. In addition, there may also be patients who have other contraindications or anatomic limitations to the use of these items.

I suspect that as these new delivery systems become more available and affordable, and if they prove to be safe and efficacious, they will be tremendous additions to our current method of treatment. That being said, as the traditional drop regimens continue to work well, many patients and surgeons will likely choose to stick with the well-established methods. There will likely always be a place for traditional drops, particularly with the newer drops that require less frequent dosing.

Kenneth A. Beckman, MD, FACS, is an OSN Cornea/External Disease Board Member. Disclosure: Beckman reports no relevant financial disclosures.

COUNTER

Drug delivery will change greatly

Eric D. Donnenfeld, MD
Eric D. Donnenfeld

The FDA approvals of Dexycu (EyePoint Pharmaceuticals), an intracameral sustained-release dexamethasone suspension, and Dextenza (Ocular Therapeutix), a bioabsorbable intracanalicular hydrogel plug that provides sustained-release dexamethasone into the tear film, are the harbingers of a new era in drug delivery for patients undergoing intraocular surgery. Drug delivery is a significant challenge for many patients. Many elderly patients have difficulty instilling eye drops, and noncompliance becomes a major challenge in achieving therapeutic results. There are issues with what I call the 5 Cs: Compliance, corneal toxicity, comfort, cost and cosmesis are among the reasons for consideration of new and better drug delivery methods. In addition, quality of life, which is a major goal of cataract surgery, is much improved with sustained drug delivery.

Challenges associated with instilling eye drops are well documented. Drop volumes range from 20 µL to 50 µL, but the pre-corneal space only holds about 7 µL, and using multiple eye drops results in washout. What’s more, only about 5% of an applied drug is absorbed into the eye, with most of that staying in the anterior segment.

There is significant noncompliance among post-cataract patients, with the literature showing that 31% of cataract patients saying they had difficulty inserting drops and 92% using 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 caregiver.

In conclusion, ophthalmic drug delivery avoids challenges associated with topical medications, such as poor compliance, corneal toxicity, discomfort, cost and cosmesis. Sustained drug delivery in cataract surgery removes these concerns and places the physician in control of the patients’ postoperative care, helping to reduce the incidence of complications due to medication noncompliance. Given the breadth of options already available or in development, drug delivery will inevitably change greatly over the next several years.

Eric D. Donnenfeld, MD, is an OSN Corneal/External Disease Board Member. Disclosure: Donnenfeld reports relevant disclosures with Allergan, EyePoint Pharmaceuticals, Kala Pharmaceuticals, Mati Pharmaceuticals and Ocular Therapeutix.

COUNTER

Depot steroids are the future

Rahul S. Tonk, MD, MBA
Rahul S. Tonk

As ophthalmologists, we know that good control of postsurgical inflammation is critical to achieving a safe and rapid visual recovery with high patient satisfaction.

Our standard of care for treating this inflammation has been to use steroid eye drops. While these have an excellent track record of safety and efficacy, they leave much to be desired in terms of patient adherence, comfort, corneal toxicity and cost.

Periocular and intraocular steroid injections, whether administered by the sub-Tenon’s, intracameral or intravitreal route, have been used for decades to control ocular inflammation. Nonetheless, their specific use in cataract surgery has been hindered by their relative invasiveness and the lack of on-label FDA approval.

Thus, I welcome the recent FDA approval of two preservative-free, sustained-release depot formulations of steroid: Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix) and Dexycu (dexamethasone intraocular suspension 9%, EyePoint Pharmaceuticals). In phase 3 clinical trials, both demonstrated a good safety profile with early, sustained relief of pain and inflammation as compared with placebo.

The central benefit of using a depot steroid is the reduction of patient nonadherence or dosing miscalculations that can occur in a geriatric cataract surgery population. One study that electronically monitored drop use in postsurgical patients demonstrated missed doses or broad gaps between doses in 50% of patients. Another study found that more than 90% of patients used an improper administration technique. Nonadherence raises the risk for persistent ocular inflammation, cystoid macular edema, posterior capsular opacification and secondary glaucoma. More broadly, it places a burden on patients’ families, ophthalmic practices and the health care system at large.

Depot steroids may not be ideal for every patient, and some may still need topical steroids or NSAIDs as a rescue medication to control inflammation. Nevertheless, Dextenza and Dexycu are promising advancements in postoperative steroid delivery that may tip the balance away from eye drops.

Rahul S. Tonk, MD, MBA, is an assistant professor of ophthalmology at Bascom Palmer Eye Institute at University of Miami Miller School of Medicine. Disclosure: Tonk reports no relevant financial disclosures.

Click here to read the Cover Story, "New steroid options allow surgeons to better tailor postoperative treatment."

POINT

Always room for drops

Changes in post-cataract surgery steroid delivery have garnered significant attention in recent years. Traditionally, patients have been forced to use steroid drops several times per day for several weeks to control postop inflammation. Unfortunately, this can be difficult for many patients. Often, these patients are elderly and not capable of placing drops several times per day. This can place a burden on family members to ensure that the drops are delivered. This may also lead to poor compliance, which may then lead to complications and poor outcomes. In addition, the cost of these drops may cause another barrier to the patient.

In recent years, there have been numerous new preparations of steroid drops, as well as new avenues for drug delivery. Some of the newer formulations may allow a patient to use the drops at a much lower frequency, which certainly can improve compliance and decrease the lifestyle burden of frequent drops. The problem with these, just as with any new medication, is cost. Many insurance companies do not allow newer formulations of drugs that already exist in other forms, and the cost may be significantly higher.

Kenneth A. Beckman, MD, FACS
Kenneth A. Beckman

With the advent of intraoperative deposition of steroids, whether in the canaliculus or intraocularly, we may be able to eliminate the postoperative drop regimen entirely. While this would be ideal for the patient, there are barriers to this regimen as well. First, there is the cost to the surgery center. The cost of the drug comes out of the facility payment, and there needs to be an adequate reimbursement formula for the center to allow this to be done. Second, the deposited medication may not be reversible. If an intraocular deposition of a steroid is causing a complication, such as high pressure, the problem cannot be treated by stopping the medication. Third, but most importantly, the drugs need to be safe and efficacious. So far, it appears that they are. Physicians and patients need to be certain that the medication will work and do no harm. In addition, there may also be patients who have other contraindications or anatomic limitations to the use of these items.

I suspect that as these new delivery systems become more available and affordable, and if they prove to be safe and efficacious, they will be tremendous additions to our current method of treatment. That being said, as the traditional drop regimens continue to work well, many patients and surgeons will likely choose to stick with the well-established methods. There will likely always be a place for traditional drops, particularly with the newer drops that require less frequent dosing.

Kenneth A. Beckman, MD, FACS, is an OSN Cornea/External Disease Board Member. Disclosure: Beckman reports no relevant financial disclosures.

PAGE BREAK

COUNTER

Drug delivery will change greatly

Eric D. Donnenfeld, MD
Eric D. Donnenfeld

The FDA approvals of Dexycu (EyePoint Pharmaceuticals), an intracameral sustained-release dexamethasone suspension, and Dextenza (Ocular Therapeutix), a bioabsorbable intracanalicular hydrogel plug that provides sustained-release dexamethasone into the tear film, are the harbingers of a new era in drug delivery for patients undergoing intraocular surgery. Drug delivery is a significant challenge for many patients. Many elderly patients have difficulty instilling eye drops, and noncompliance becomes a major challenge in achieving therapeutic results. There are issues with what I call the 5 Cs: Compliance, corneal toxicity, comfort, cost and cosmesis are among the reasons for consideration of new and better drug delivery methods. In addition, quality of life, which is a major goal of cataract surgery, is much improved with sustained drug delivery.

Challenges associated with instilling eye drops are well documented. Drop volumes range from 20 µL to 50 µL, but the pre-corneal space only holds about 7 µL, and using multiple eye drops results in washout. What’s more, only about 5% of an applied drug is absorbed into the eye, with most of that staying in the anterior segment.

There is significant noncompliance among post-cataract patients, with the literature showing that 31% of cataract patients saying they had difficulty inserting drops and 92% using 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 caregiver.

In conclusion, ophthalmic drug delivery avoids challenges associated with topical medications, such as poor compliance, corneal toxicity, discomfort, cost and cosmesis. Sustained drug delivery in cataract surgery removes these concerns and places the physician in control of the patients’ postoperative care, helping to reduce the incidence of complications due to medication noncompliance. Given the breadth of options already available or in development, drug delivery will inevitably change greatly over the next several years.

Eric D. Donnenfeld, MD, is an OSN Corneal/External Disease Board Member. Disclosure: Donnenfeld reports relevant disclosures with Allergan, EyePoint Pharmaceuticals, Kala Pharmaceuticals, Mati Pharmaceuticals and Ocular Therapeutix.

PAGE BREAK

COUNTER

Depot steroids are the future

Rahul S. Tonk, MD, MBA
Rahul S. Tonk

As ophthalmologists, we know that good control of postsurgical inflammation is critical to achieving a safe and rapid visual recovery with high patient satisfaction.

Our standard of care for treating this inflammation has been to use steroid eye drops. While these have an excellent track record of safety and efficacy, they leave much to be desired in terms of patient adherence, comfort, corneal toxicity and cost.

Periocular and intraocular steroid injections, whether administered by the sub-Tenon’s, intracameral or intravitreal route, have been used for decades to control ocular inflammation. Nonetheless, their specific use in cataract surgery has been hindered by their relative invasiveness and the lack of on-label FDA approval.

Thus, I welcome the recent FDA approval of two preservative-free, sustained-release depot formulations of steroid: Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix) and Dexycu (dexamethasone intraocular suspension 9%, EyePoint Pharmaceuticals). In phase 3 clinical trials, both demonstrated a good safety profile with early, sustained relief of pain and inflammation as compared with placebo.

The central benefit of using a depot steroid is the reduction of patient nonadherence or dosing miscalculations that can occur in a geriatric cataract surgery population. One study that electronically monitored drop use in postsurgical patients demonstrated missed doses or broad gaps between doses in 50% of patients. Another study found that more than 90% of patients used an improper administration technique. Nonadherence raises the risk for persistent ocular inflammation, cystoid macular edema, posterior capsular opacification and secondary glaucoma. More broadly, it places a burden on patients’ families, ophthalmic practices and the health care system at large.

Depot steroids may not be ideal for every patient, and some may still need topical steroids or NSAIDs as a rescue medication to control inflammation. Nevertheless, Dextenza and Dexycu are promising advancements in postoperative steroid delivery that may tip the balance away from eye drops.

Rahul S. Tonk, MD, MBA, is an assistant professor of ophthalmology at Bascom Palmer Eye Institute at University of Miami Miller School of Medicine. Disclosure: Tonk reports no relevant financial disclosures.