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Diamonds are forever: Perioperative options optimize cataract surgery

The recovery process is improved with as little reliance on patient compliance as possible.

There is an old phrase that “diamonds are forever” because of the strength and resilience a diamond represents when people use their lifetime savings to express their love, hoping that diamond is a symbol of an everlasting relationship. As we really know, diamonds, unfortunately, do not last forever, but rather degrade to graphite over time and can even have many minute imperfections not detectable by the naked eye.

So how can diamonds have anything to do with a premium surgeon’s choices surrounding cataract surgery when it comes to recovering patients from inflammation and corneal edema, and protecting the macula from cystoid edema? Below I discuss novel ways utilizing a variety of steroid formulations and new devices to improve the patient recovery process from these harmful conditions by eliminating the need for patient compliance in terms of cost issues and utilization issues. As many premium cataract surgeons experience daily, patients may not use what we prescribe because they were substituted to a generic variant at the pharmacy level based on pharmacist incentives, insurance directives and/or patient affordability issues. The good news is several new steroid options have arrived to optimize the cataract surgery recovery process.

Novel steroid devices

Dextenza (Ocular Therapeutix) is a 0.4 mg dexamethasone intracanalicular insert approved by the FDA for treating pain and inflammation after cataract surgery that will “dissolve” over a 30-day period. The insert is placed in the canaliculus at the time of cataract surgery and is reimbursed through government-subsidized pass-through process. The dimension of the Dextenza insert in its dry state before placement is 0.5 mm in diameter and 3 mm in length, and it is placed into the canaliculus that is on average 2 mm in vertical length and 10 mm in horizontal length. The key to a successful implantation is keeping the insert dry the entire time of insertion so it does not swell, dilating the lower punctum well, directing the insertion based on the canaliculus anatomy in a more horizontal “stretched” fashion, and keeping the lower lid area as dry as possible as well. Removing surgical gloves at the end of the cataract surgery to help stretch the lower lid horizontally with a dry hand facilitates this process as well. This device is extremely useful in my premium IOL patients, as I find it aids in the ocular surface recovery during that initial 30-day immediate postoperative time period after cataract surgery. It is always good practice to evaluate the lower puncta at the slit lamp during the preoperative cataract evaluation to be sure they are not too stenotic and can be dilated in the first place at the time of cataract surgery.

Dexycu (EyePoint Pharmaceuticals) is a Verisome drug delivery system of 5 µL of 517 µg of dexamethasone intraocular suspension 9% placed under the posterior iris at the conclusion of the cataract case. This special formulation provides for a relatively high initial release of dexamethasone, then tapering rapidly to a sustained clinical effect of 30 days. This FDA-approved product showed clinically significant clearance of anterior chamber cell at postoperative day 8 compared with placebo, 60% to 20% (P < .001). IOP, other than normal postoperative day 1 retained viscoelastic spikes, remained statistically unchanged from preoperative baseline levels out to day 90 postoperatively. Personally, I prefer this device for my denser cataracts in which patients have typically been in denial in the first place by not coming in to get their cataracts removed sooner. These patients are usually the least compliant types of patients postoperatively, so having the steroid in the eye definitely eliminates the patient compliance issue.

Novel steroid drop formulations

Lotemax SM (loteprednol etabonate gel 0.38%, Bausch + Lomb) is a novel retrometabolic-designed corticosteroid FDA approved to treat pain and inflammation after cataract surgery but with a lower concentration compared with its predecessor, Lotemax Gel 0.5%, and less frequent dosing, three times a day compared with four times a day. It still contains the advantage of being a mucoadhesive, non-settling, shear-tinning gel that dissipates to tear film quality once it touches the ocular surface, avoiding blurred vision associated with other topical eye gel formulas. A big advantage of this “small but mighty” submicron formulation is it retains its potent anti-inflammatory effect at 80% smaller particle size and twice the penetration into the aqueous humor and has essentially no effect on IOP due to its ester substitution in place of a ketone. The final advantage is its ocular surface comfort at a pH of 6.5 is close to that of natural tears and low preservative of only 0.003% benzalkonium chloride creates little, if any, ocular surface toxicity.

Inveltys (loteprednol etabonate 1% ophthalmic suspension, Kala Pharmaceuticals) is another novel topical corticosteroid FDA approved as a nanoparticle formulation (200 nm to 400 nm), powered by the Ampplify drug delivery system, which contains a proprietary mucus-penetrating surface coating to prevent adherence to mucins covering the corneal surface. This novel design in vitro showed 3.3 times the aqueous humor concentration when compared with traditional Lotemax 0.5% suspension without Ampplify. As a result, it received labelling for twice daily dosing for pain and inflammation after cataract surgery. Like other loteprednol ester steroids, there was minimal effect on IOP elevation in the 2 weeks of use following cataract surgery.

Flarex (fluorometholone acetate suspension 0.1%, Eyevance Pharmaceuticals) is a steroid returning to the market with the broadest FDA label among the most popular used steroids today, not only for inflammation after any anterior segment surgery (including cataract surgery) but also for ocular surface inflammation management. The latter becomes even more critical when premium surgeons are placing advanced premium IOLs in their patients and need a preoperative healthy ocular surface for better diagnostic acquisition and a postoperative pristine ocular surface for visual stability and clarity that remains consistent throughout the day, especially with all near vision tasks. The acetate formulation gives better penetration than its predecessor alcohol formulation without causing any significant elevations in IOP.

In summary, as new approaches come to the forefront in steroid usage around cataract surgery, the goal is to optimize the recovery process for the patient with as little reliance on patient compliance as possible. Just as diamonds do not last forever, nor will any of these options as better formulations and intraocular devices will continue to evolve to optimize cataract surgery for our patients.

Disclosure: Jackson reports he is a consultant for Bausch + Lomb, Kala, EyePoint Pharmaceuticals, Ocular Therapeutix and Eyevance Pharmaceuticals.

There is an old phrase that “diamonds are forever” because of the strength and resilience a diamond represents when people use their lifetime savings to express their love, hoping that diamond is a symbol of an everlasting relationship. As we really know, diamonds, unfortunately, do not last forever, but rather degrade to graphite over time and can even have many minute imperfections not detectable by the naked eye.

So how can diamonds have anything to do with a premium surgeon’s choices surrounding cataract surgery when it comes to recovering patients from inflammation and corneal edema, and protecting the macula from cystoid edema? Below I discuss novel ways utilizing a variety of steroid formulations and new devices to improve the patient recovery process from these harmful conditions by eliminating the need for patient compliance in terms of cost issues and utilization issues. As many premium cataract surgeons experience daily, patients may not use what we prescribe because they were substituted to a generic variant at the pharmacy level based on pharmacist incentives, insurance directives and/or patient affordability issues. The good news is several new steroid options have arrived to optimize the cataract surgery recovery process.

Novel steroid devices

Dextenza (Ocular Therapeutix) is a 0.4 mg dexamethasone intracanalicular insert approved by the FDA for treating pain and inflammation after cataract surgery that will “dissolve” over a 30-day period. The insert is placed in the canaliculus at the time of cataract surgery and is reimbursed through government-subsidized pass-through process. The dimension of the Dextenza insert in its dry state before placement is 0.5 mm in diameter and 3 mm in length, and it is placed into the canaliculus that is on average 2 mm in vertical length and 10 mm in horizontal length. The key to a successful implantation is keeping the insert dry the entire time of insertion so it does not swell, dilating the lower punctum well, directing the insertion based on the canaliculus anatomy in a more horizontal “stretched” fashion, and keeping the lower lid area as dry as possible as well. Removing surgical gloves at the end of the cataract surgery to help stretch the lower lid horizontally with a dry hand facilitates this process as well. This device is extremely useful in my premium IOL patients, as I find it aids in the ocular surface recovery during that initial 30-day immediate postoperative time period after cataract surgery. It is always good practice to evaluate the lower puncta at the slit lamp during the preoperative cataract evaluation to be sure they are not too stenotic and can be dilated in the first place at the time of cataract surgery.

PAGE BREAK

Dexycu (EyePoint Pharmaceuticals) is a Verisome drug delivery system of 5 µL of 517 µg of dexamethasone intraocular suspension 9% placed under the posterior iris at the conclusion of the cataract case. This special formulation provides for a relatively high initial release of dexamethasone, then tapering rapidly to a sustained clinical effect of 30 days. This FDA-approved product showed clinically significant clearance of anterior chamber cell at postoperative day 8 compared with placebo, 60% to 20% (P < .001). IOP, other than normal postoperative day 1 retained viscoelastic spikes, remained statistically unchanged from preoperative baseline levels out to day 90 postoperatively. Personally, I prefer this device for my denser cataracts in which patients have typically been in denial in the first place by not coming in to get their cataracts removed sooner. These patients are usually the least compliant types of patients postoperatively, so having the steroid in the eye definitely eliminates the patient compliance issue.

Novel steroid drop formulations

Lotemax SM (loteprednol etabonate gel 0.38%, Bausch + Lomb) is a novel retrometabolic-designed corticosteroid FDA approved to treat pain and inflammation after cataract surgery but with a lower concentration compared with its predecessor, Lotemax Gel 0.5%, and less frequent dosing, three times a day compared with four times a day. It still contains the advantage of being a mucoadhesive, non-settling, shear-tinning gel that dissipates to tear film quality once it touches the ocular surface, avoiding blurred vision associated with other topical eye gel formulas. A big advantage of this “small but mighty” submicron formulation is it retains its potent anti-inflammatory effect at 80% smaller particle size and twice the penetration into the aqueous humor and has essentially no effect on IOP due to its ester substitution in place of a ketone. The final advantage is its ocular surface comfort at a pH of 6.5 is close to that of natural tears and low preservative of only 0.003% benzalkonium chloride creates little, if any, ocular surface toxicity.

Inveltys (loteprednol etabonate 1% ophthalmic suspension, Kala Pharmaceuticals) is another novel topical corticosteroid FDA approved as a nanoparticle formulation (200 nm to 400 nm), powered by the Ampplify drug delivery system, which contains a proprietary mucus-penetrating surface coating to prevent adherence to mucins covering the corneal surface. This novel design in vitro showed 3.3 times the aqueous humor concentration when compared with traditional Lotemax 0.5% suspension without Ampplify. As a result, it received labelling for twice daily dosing for pain and inflammation after cataract surgery. Like other loteprednol ester steroids, there was minimal effect on IOP elevation in the 2 weeks of use following cataract surgery.

PAGE BREAK

Flarex (fluorometholone acetate suspension 0.1%, Eyevance Pharmaceuticals) is a steroid returning to the market with the broadest FDA label among the most popular used steroids today, not only for inflammation after any anterior segment surgery (including cataract surgery) but also for ocular surface inflammation management. The latter becomes even more critical when premium surgeons are placing advanced premium IOLs in their patients and need a preoperative healthy ocular surface for better diagnostic acquisition and a postoperative pristine ocular surface for visual stability and clarity that remains consistent throughout the day, especially with all near vision tasks. The acetate formulation gives better penetration than its predecessor alcohol formulation without causing any significant elevations in IOP.

In summary, as new approaches come to the forefront in steroid usage around cataract surgery, the goal is to optimize the recovery process for the patient with as little reliance on patient compliance as possible. Just as diamonds do not last forever, nor will any of these options as better formulations and intraocular devices will continue to evolve to optimize cataract surgery for our patients.

Disclosure: Jackson reports he is a consultant for Bausch + Lomb, Kala, EyePoint Pharmaceuticals, Ocular Therapeutix and Eyevance Pharmaceuticals.