DEXYCU® (dexamethasone intraocular suspension) 9% Case Study Series

I. Paul Singh, MO

Dr. I. Paul Singh, a Wisconsin native, is the President of The Eye Centers of Racine & Kenosha, ltd , founded in 1981 by his father, Dr. Kanwar A. Singh He completed his fellowship in Glaucoma at Duke University in July 2004 before returning back to his hometown where he is currently in private practice.

In this video from a cataract surgery case, I. Paul Singh, MD, provides tips for administering the dexamethasone intraocular suspension DEXYCU post-surgery.

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INDICATION AND USAGE 
DEXYCU^® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.
 
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
None.

Please see continued Important Safety Information below and a link to the full Prescribing Information.

Steven M. Silverstein, MD, FACS

Clinical Professor of Ophthalmology, Kansas City University of Medicine and Biomedical Sciences.

In this video from a cataract surgery case, Steven M. Silverstein, MD, provides tips for administering DEXYCU into the posterior chamber at the end of ocular surgery to treat postoperative inflammation.

" >

IMPORTANT SAFETY INFORMATION (cont'd)

WARNINGS AND PRECAUTIONSIncrease in Intraocular Pressure

• Prolonged use of corticosteroids, including DEXYCU, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision

• Steroids should be used with caution in the presence of glaucoma

Please see continued Important Safety Information below and a link to the full Prescribing Information.

Ehsan Sadri, M.D., FACS, FAAO

Dr. Ehsan Sadri is board-certified and fellowship-trained in cataract surgery, LASIK and glaucoma surgery. He is trained in the most progressive ocular surgical techniques including cataract surgery, phakic intraocular lenses, LASIK, PRK, refractive lensectomy, and AK.

In this article from a cataract surgery case, Ehsan Sadri, M.D., FACS, FAAO, provides tips for administering DEXYCU after ocular surgery.

Read Article

Please see continued Important Safety Information below and a link to the full Prescribing Information.

IMPORTANT SAFETY INFORMATION (cont'd)

WARNINGS AND PRECAUTIONS (cont'd)

Delayed Healing

• The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation

• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids

Exacerbation of Infection

• The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures

• Use of a corticosteroid in the treatment of patients with a history of herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections

• Fungal infections of the cornea are particularly prone to coincidentally develop with long-term local steroid application and must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate

• Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection

Cataract Progression

• The use of corticosteroids in phakic inpiduals may promote the development of posterior subcapsular cataracts

ADVERSE REACTIONS

• The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis

Please see Full Prescribing Information for DEXYCU.

11/2019
US-DEX-1900204

DEXYCU and the DEXYCU logo are registered trademarks of EyePoint Pharmaceuticals, Inc.

I. Paul Singh, MO
Dr. I. Paul Singh, a Wisconsin native, is the President of The Eye Centers of Racine & Kenosha, ltd , founded in 1981 by his father, Dr. Kanwar A. Singh He completed his fellowship in Glaucoma at Duke University in July 2004 before returning back to his hometown where he is currently in private practice.

Sustained-release DEXYCU^® (dexamethasone intraocular suspension) 9% is a novel intraocular product that may eliminate the need for steroid drops, which in some regimens can include 70 or more drops over 4 weeks.^1,2 This one-time treatment provides most cataract surgery patients a corticosteroid that can help suppress postoperative inflammation up to 30 days.¹ The cumulative percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drug (NSAID) by day 30 was significantly lower in the DEXYCU 517 mcg treatment group (20%; n=31/156) compared to placebo (54%; n=43/80).¹

Clinical trial data demonstrated that DEXYCU is effective for clearing anterior chamber cells.^1*

• The percentage of patients who received DEXYCU (517 mcg) who had anterior chamber cell clearing on day 8 was 60% (n=94/156) vs 20% (n=16/80) in the placebo group¹

The most common side effects were increased intraocular pressure, corneal edema, and iritis.¹ In a phase 3 clinical trial, mean intraocular pressure elevations in the placebo and DEXYCU treatment groups were transient at day 1 and returned to baseline by day 3.³

INDICATION AND USAGE 
DEXYCU^® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.
 
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
None.

Please see continued Important Safety Information below and link to full Prescribing Information.

Since DEXYCU is placed at the sight of inflammation, it eliminates concerns of this drug penetrating the cornea, ocular surface toxicity due to this medication, and washout by tearing or other drops being administered.^4,5 I find that DEXYCU is easy to administer in my patients. After bringing the anterior chamber to normotension, I introduce the delivery cannula into the eye and advance it into the sulcus, directly across from the main incision, so that the tip is under the iris. Then, like laying down a bead of caulk, I inject DEXYCU while moving the cannula tip in a continuous motion towards 6 o’clock.

After DEXYCU is delivered, some of the medication may spill out of the sulcus into the anterior chamber. In a phase 3 multicenter, randomized study that compared the efficacy and safety of DEXYCU and prednisolone acetate, it was found that in 57% of the cases DEXYCU did not remain behind the iris on Postoperative Day 1.⁶  Anticipating the possibility, however, patients should be told they may see a white “pearl” of medicine when they look in the mirror and that it will dissolve over time.

* DEXYCU was studied in a randomized, double-masked, placebo-controlled trial.¹ Patients received either DEXYCU or a vehicle administered by a physician at the end of the surgical procedure. The primary endpoint was the proportion of patients with anterior chamber cell clearing (cell score = 0) on postoperative day 8.

Next Video »

IMPORTANT SAFETY INFORMATION (cont'd)

WARNINGS AND PRECAUTIONSIncrease in Intraocular Pressure

• Prolonged use of corticosteroids, including DEXYCU, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision

• Steroids should be used with caution in the presence of glaucoma

Delayed Healing

• The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation

• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids

Exacerbation of Infection

• The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures

• Use of a corticosteroid in the treatment of patients with a history of herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections

• Fungal infections of the cornea are particularly prone to coincidentally develop with long-term local steroid application and must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate

• Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection

Cataract Progression

• The use of corticosteroids in phakic inpiduals may promote the development of posterior subcapsular cataracts

ADVERSE REACTIONS

• The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis

Please see Full Prescribing Information for DEXYCU.

References

• DEXYCU^® (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. December 2018.

• Durezol^® (difluprednate ophthalmic emulsion) 0.05% full U.S. Prescribing Information. Alcon Laboratories, Inc. April 2017.

• Data on file, EyePoint Pharmaceuticals Inc.

• Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;12(3):348-360.

• Jones L, Downie LE, Korb D, et al. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017;15(3):575-628.

• Donnenfeld E, Holland E. Dexamethasone intracameral drug-delivery suspension for inflammation associated with cataract surgery: a randomized, placebo-controlled, phase III trial. Ophthalmology. 2018;125(6):799-806.

10/2019
US-DEX-1900205

DEXYCU is a registered trademark of EyePoint Pharmaceuticals, Inc. ©2019 EyePoint Pharmaceuticals, Inc. All rights reserved. 480 Pleasant Street, Suite B300, Watertown, MA 02472.

Steven M. Silverstein, MD, FACS

Clinical Professor of Ophthalmology, Kansas City University of Medicine and Biomedical Sciences.

INDICATION AND USAGE 
DEXYCU^® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.
 
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
None.

Please see continued Important Safety Information below and link to full Prescribing Information.

In this video from a cataract surgery case, Steven M. Silverstein, MD, provides tips for injecting DEXYCU^® (dexamethasone intraocular suspension) 9% into the posterior chamber at the end of ocular surgery to treat postoperative inflammation.^1-3

Sustained-release DEXYCU is a novel intraocular product that may eliminate the need for steroid drops, which in some regimens can include 70 or more drops over 4 weeks.^1,4 This one-time treatment provides most cataract surgery patients a corticosteroid that can help suppress postoperative inflammation over 30 days.¹ The cumulative percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drug (NSAID) by day 30 was significantly lower in the DEXYCU 517 mcg treatment group (20%; n=31/156) compared to placebo (54%; n=43/80)¹

Clinical trial data demonstrated that DEXYCU is effective for clearing anterior chamber cells.¹

• The percentage of patients who received DEXYCU (517 mcg) who had anterior chamber cell clearing on day 8 was 60% (n=94/156) vs 20% (n=16/80) in the placebo group¹

• DEXYCU was studied in a randomized, double-masked, placebo-controlled trial.¹ Patients received either DEXYCU or a vehicle administered by a physician at the end of the surgical procedure. The primary endpoint was the proportion of patients with anterior chamber cell clearing (cell score = 0) on postoperative day 8.³

The most commonly reported adverse reactions occurred in 5-15% of subjects who received DEXYCU and included increases in intraocular pressure, corneal edema, and iritis.¹ In a phase 3 clinical trial, mean intraocular pressure elevations in the placebo and DEXYCU treatment groups were transient at day 1 and returned to baseline by day 3.³

Since DEXYCU is placed at the site of inflammation, it eliminates concerns of this drug penetrating the cornea, ocular surface toxicity due to this medication, and washout by tearing or other drops being administered.^5,6 I find that DEXYCU is easy to administer in my patients. After bringing the anterior chamber to normotension, I introduce the delivery cannula into the eye and advance it into the sulcus, directly across from the main incision, so that the tip is under the iris. Then, like laying down a bead of caulk, I inject DEXYCU while moving the cannula tip in a continuous motion towards 6 o’clock.

After DEXYCU is delivered, some of the medication may spill out of the sulcus into the anterior chamber. In a phase 3 multicenter, randomized study that compared the efficacy and safety of DEXYCU and prednisolone acetate, it was found that in 57% of the cases, DEXYCU did not remain behind the iris on Postoperative Day 1.⁷ Anticipating the possibility, patients should be told they may see a white “pearl” of medicine when they look in the mirror and that it will dissolve over time.^2,8

Next Article »

IMPORTANT SAFETY INFORMATION (cont'd)

WARNINGS AND PRECAUTIONSIncrease in Intraocular Pressure

• Prolonged use of corticosteroids, including DEXYCU, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision

• Steroids should be used with caution in the presence of glaucoma

Delayed Healing

• The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation

• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids

Exacerbation of Infection

• The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures

• Use of a corticosteroid in the treatment of patients with a history of herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections

• Fungal infections of the cornea are particularly prone to coincidentally develop with long-term local steroid application and must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate

• Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection

Cataract Progression

• The use of corticosteroids in phakic inpiduals may promote the development of posterior subcapsular cataracts

ADVERSE REACTIONS

• The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis

Please see Full Prescribing Information for DEXYCU.

References

• DEXYCU^® (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. December 2018.

• Donnenfeld E, Holland E. Dexamethasone intracameral drug-delivery suspension for inflammation associated with caratact surgery: a randomized, placebo-controlled, phase III trial. Ophthalmology. 2018; 125(6):700-806

• Data on file, EyePoint Pharmaceuticals Inc.

• Durezol^® (difluprednate ophthalmic emulsion) 0.05% full U.S. Prescribing Information. Alcon Laboratories, Inc.

• Jones L, Downie LE, Korb D, et al. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017;15(3):575-628.

• Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;12(3):348-360.

• Donnenfeld ED, Solomon KD, Matossian C. Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study. J Cataract Refract Surg. 2018;44(10):1236-1246.

• Haghjou N, Soheilian M, Abdekhodaie MJ. Sustained release intraocular drug delivery devices for treatment of uveitis. J Ophthalmic Vis Res. 2011;6(4):317-329.

10/2019
US-DEX-1900219

DEXYCU is a registered trademark and the EyePoint logo is trademark of EyePoint Pharmaceuticals, Inc. ©2019 EyePoint Pharmaceuticals, Inc. All rights reserved. 480 Pleasant Street, Suite B300, Watertown, MA 02472.

Ehsan Sadri, M.D., FACS, FAAO

Dr. Ehsan Sadri is board-certified and fellowship-trained in cataract surgery, LASIK and glaucoma surgery. He is trained in the most progressive ocular surgical techniques including cataract surgery, phakic intraocular lenses, LASIK, PRK, refractive lensectomy, and AK.

DEXYCU^® (dexamethasone intraocular suspension) 9% is an innovative product for the treatment of inflammation after ocular surgery.¹ DEXYCU is administered into the posterior chamber at the end of the surgical procedure and utilizes patented Verisome® Technology designed to release dexamethasone at the target site in a controlled, tapered manner over a period of a few weeks.^1-4

By placing the medication at the site of inflammation, it eliminates the concerns of drug penetration through the cornea.⁵ DEXYCU has a role in treating a wide variety of cataract surgery patients, and for some patients, it may eliminate the need for steroid drops that can involve 70 or more doses over a 4- week period.^1,6

• The cumulative percentage of subjects receiving rescue medication of ocular steroid or nonsteroidal anti-inflammatory drug (NSAID) by day 30 was significantly lower in the DEXYCU 517 mcg treatment group (20%; n=31/156) compared to placebo (54%; n=43/80)¹

Clinical trial data demonstrated that DEXYCU is effective for clearing anterior chamber cells.¹

• The percentage of patients who received DEXYCU (517 mcg) who had anterior chamber cell clearing on day 8 was 60% (n=94/156) vs 20% (n=16/80) in the placebo group¹

The most commonly reported adverse reactions occurred in 5-15% of subjects who received DEXYCU and included increases in intraocular pressure, corneal edema, and iritis.¹ In a phase 3 clinical trial, mean intraocular pressure elevations in the placebo and DEXYCU treatment groups were transient at day 1 and returned to baseline by day 3.³

INDICATION AND USAGE 
DEXYCU^® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.
 
IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
None.

Please see continued Important Safety Information below and link to full Prescribing Information.

Clinical trial experience with DEXYCU also gives me confidence. I was an investigator in an initial study, and I had particular concern about the potential for IOP elevations with an intraocular steroid because I am a glaucoma specialist. In a phase 3 clinical trial, mean IOP elevations in the placebo and DEXYCU treatment groups were transient at day 1 and returned to baseline by day 3.³ The most common side effects with DEXYCU were increased intraocular pressure, corneal edema, and iritis.¹

I like that DEXYCU can be visualized while it is being injected. As with any new surgical procedure, there is a learning curve for placing DEXYCU. I believe surgeons will find that proficiency is easily acquired, however, and so they should not be discouraged if they feel their technique is less than perfect in their initial cases.

I prefer to deliver DEXYCU by entering the eye through the sideport incision because this approach limits the potential for anterior chamber flattening compared with entry through the main incision. Surgeons who wish to use the main incision may consider introducing a small amount of viscoelastic first to help maintain a well-formed chamber.

DEXYCU should be placed behind the iris plane, and I deliver the medication using a fanned motion, moving the tip of the cannula from the 5 o’clock to the 3 o’clock position. Distributing the DEXYCU droplet in this manner helps to keep it behind the iris. Some of the material may migrate into the anterior chamber.⁷ In a phase 3 multicenter, randomized study that compared the efficacy and safety of DEXYCU and prednisolone acetate, it was found that in 57% of the cases, DEXYCU did not remain behind the iris on Postoperative Day 1.⁷

IMPORTANT SAFETY INFORMATION (cont'd)

WARNINGS AND PRECAUTIONSIncrease in Intraocular Pressure

• Prolonged use of corticosteroids, including DEXYCU, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision

• Steroids should be used with caution in the presence of glaucoma

Delayed Healing

• The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation

• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids

Exacerbation of Infection

• The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures

• Use of a corticosteroid in the treatment of patients with a history of herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections

• Fungal infections of the cornea are particularly prone to coincidentally develop with long-term local steroid application and must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate

• Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection

Cataract Progression

• The use of corticosteroids in phakic inpiduals may promote the development of posterior subcapsular cataracts

ADVERSE REACTIONS

• The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis

Please see Full Prescribing Information for DEXYCU.

References

• DEXYCU^® (dexamethasone intraocular suspension) 9% full U.S. Prescribing Information. EyePoint Pharmaceuticals, Inc. December 2018.

• Donnenfeld E, Holland E. Dexamethasone intracameral drug-delivery suspension for inflammation associated with caratact surgery: a randomized, placebo-controlled, phase III trial. Ophthalmology. 2018; 125(6):700-806

• Data on file, EyePoint Pharmaceuticals Inc.

• Haghjou N, Soheilian M, Abdekhodaie MJ. Sustained release intraocular drug delivery devices for treatment of uveitis. J Ophthalmic Vis Res. 2011;6(4):317-329.

• Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;12(3):348-360.

• Durezol^® (difluprednate ophthalmic emulsion) 0.05% full U.S. Prescribing Information. Alcon Laboratories, Inc.

• Donnenfeld ED, Solomon KD, Matossian C. Safety of IBI-10090 for inflammation associated with cataract surgery: Phase 3 multicenter study. J Cataract Refract Surg. 2018;44(10):1236-1246.

11/2019
US-DEX-1900234

DEXYCU and the DEXYCU logo are registered trademarks of EyePoint Pharmaceuticals, Inc. Verisome is a registered trademark of Ramscor, Inc. ©2019 EyePoint Pharmaceuticals, Inc. All rights reserved. 480 Pleasant Street, Suite B300, Watertown, MA 02472.