In this fourth installment on "2020 vision," pharmaceutical representatives share their outlook on what lies ahead for glaucoma innovations within the ophthalmic space. 

Featured: Chris Adams, Diopter Corp (CEO); Daria Lemann-Blumenthal, BELKIN Laser Ltd (CEO); Victor Chan, MB, MS, director of U.S. Surgical Device Commercial Marketing (Santen, Inc)
Ramin Valian, vice president of International Glaucoma, Reimbursement and Pipeline (Allergan).



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2020 vision: What is the future of ophthalmology?



2020 vision: The future of ophthalmology (Part II)



2020 vision: The future of ophthalmology (Part III) 

Videos

GLAUCOMA 360

In this fourth installment on "2020 vision," pharmaceutical representatives share their outlook on what lies ahead for glaucoma innovations within the ophthalmic space.  

2020 vision: The future of ophthalmology (Part IV)

Results of a prospective randomized trial comparing five medication regimens for controlling inflammation early after uncomplicated surgery show that beginning monotherapy with a topical non-steroidal anti-inflammatory drug (NSAID) on the day of surgery offered the best outcome for efficacy and safety.

The research, which was presented by Jesper Høiberg Erichsen, MD, at ARVO 2020, found that adding a topical steroid to the NSAID provided no benefit but could adversely affect IOP. Initiating topical treatment three days preoperatively also conferred no advantage for better inflammation control, while a dropless approach using a subTenon’s corticosteroid injection proved inferior to topical treatment.

“Controlling postoperative inflammation is important for achieving a successful outcome after cataract surgery. Surgeons generally prescribe an anti-inflammatory prophylactic regimen parallel to surgery, and recent meta-analyses have documented a beneficial effect of using a topical NSAID. Yet, there are several questions about inflammation prophylaxis that need to be investigated,” said Erichsen, a doctorate student, Department of Ophthalmology, Rigshospitalet-Glostrup, Glostrup, Denmark.
“Based on our results, we recommend that cataract surgeons consider using NSAID monotherapy as anti-inflammatory prophylaxis in uncomplicated cases.”  

Patients with a senile cataract were eligible for enrollment in the study if they were undergoing uncomplicated surgery and had no history of diabetes, uveitis, glaucoma, retinal vein occlusion, epiretinal membrane, retinal detachment, or advanced age-related macular degeneration. A total of 470 patients were randomized equally into five groups to receive topical prednisolone and ketorolac started 3 days preoperatively, topical prednisolone and ketorolac started on the day of surgery, ketorolac started 3 days preoperatively, ketorolac started on the day of surgery, or a subTenon’s depot of dexamethasone 2 mg/0.5 mL All topical drops were to be administered three times daily and continued for 21 days after surgery.

Fourteen patients were excluded after randomization, and 438 patients completed follow-up to the primary endpoint visit at postoperative day 3. The mean age of the 456 patients included in the baseline data analysis was 72 years. Almost two-thirds of the study participants were women.

The primary outcome assessed change from baseline in anterior chamber flare measured on undilated pupils using a flare photometer (KOWA FM-600, KOWA Company). For statistical analyses, the group that received the combination topical regimen started preoperatively was used as the control group.

Median flare was 10.1 ph/ms at baseline in all groups, and it increased significantly at postop day 3 in all groups. The greatest increase occurred in the dropless group, and the difference in change from baseline compared with the control group was statistically significant only in the dropless group.

“As another interesting result, we found that only a few patients in the topical treatment groups (1.1% to 3.4%) needed additional intervention to control inflammation, whereas more than one-third of patients in the dropless group needed rescue anti-inflammatory treatment,“ Erichsen said. “Minimizing the need for topical drops is desirable in older patients who may struggle with administration, but the dropless approach using the subTenon’s injection did not seem effective for achieving that goal.”

Anterior chamber cell count at postop day 3 was investigated as a secondary outcome measure. The mean value was 3.4 in the control group, ranged from 3.8 to 4.1 in the three other topical regimen groups, and was 5.5 in the dropless group. Again, only the difference between the dropless group and control group was statistically significant.

Postop day 3 logMAR visual acuity measured with ETDRS charts was also evaluated as a secondary endpoint. The results showed no significant differences between groups.

Intraocular pressure was another secondary outcome measure in the study, and it was found to decrease significantly after cataract surgery in all groups. However, the decrease was significantly less in the combination treatment groups that received a topical steroid compared with the groups receiving a topical NSAID alone and the dropless group.

Neither Dr. Erichsen nor any of his co-authors has any relevant financial interests to disclose.

Articles

ARVO

Large randomized trial compares efficacy and safety of multiple regimens

Minimizing inflammation post-cataract surgery

Results of a phase 2 trial suggest that dexamethasone cyclodextrin nanoparticle ophthalmic suspension 1.5% mg/mL (OCS-01, Oculis), a novel topical formulation of dexamethasone, has the potential to become the first once-daily and preservative-free topical corticosteroid for treating pain and inflammation after ocular surgery, said Eric D. Donnenfeld, MD, at the 2020 ASCRS virtual meeting.

Donnenfeld reported results from the SKYGGN study that randomly selected 153 patients 1:1:1 to treatment with OCS-01 once daily, OCS-01 twice daily, or vehicle for 14 days. The study met its primary endpoints analyzing absence of anterior chamber cells at postop day 15 and absence of ocular pain at postop day 4. There were no efficacy differences between the two OCS-01 dosing regimens and both were safe and well-tolerated.

“Inflammation and pain remain expected consequences of ocular surgery. Although available topical steroids are effective for treating these sequelae, potency and compliance with products that need to be used several times a day are major issues,” said Donnenfeld, a SKYGGN investigator who is clinical professor of ophthalmology, New York University Langone Medical Center, New York, and Founding Partner, Ophthalmic Consultants of Long Island and Connecticut, Garden City, NY. “Using a novel and proprietary nanoparticle formulation, OCS-01 was developed to deliver a potent anti-inflammatory effect and excellent safety profile with once-a-day dosing.”

Donnenfeld noted that the concentration of dexamethasone in OCS-01 is 15-fold greater than that found in commercially available topical dexamethasone suspension. In addition, the novel vehicle used for OCS-01 increases ocular surface residency time to hours compared with minutes using conventional dexamethasone 0.1% suspension. Furthermore, the proprietary nanoparticle technology enhances penetration of the active ingredient. As another benefit, the formulation is preservative-free.

A total of 20 US centers participated in the SKYGGN study. Patients were eligible for enrollment if they had an anterior chamber cell score ≥ 2 at their first postoperative visit 18 to 30 hours post-uncomplicated cataract surgery and a pin-hole ETDRS visual acuity without any other correction that was >20 letters (approximately 20/400) in the operative eye and >35 letters (approximately 20/200) in the fellow eye. Follow-up visits were scheduled at postoperative days 4, 8, 15, and 22.

The three study groups were similar at baseline in their demographic characteristics, and 148 patients completed the study. Mean age of patients across the three groups ranged from 66 to 68 years, approximately two-thirds of subjects were female, and the vast majority were Caucasian.

The percentage of patients with absence of anterior chamber cells on day 15 in the OCS-01 once daily, OCS-01 twice daily, and vehicle groups was 51.0%, 66.7%, and 45.1%, respectively (

<.0001 for both OCS-01 groups vs. vehicle). Absence of pain on day 4 was achieved by 72.5% of patients treated with OCS-01 once daily and 19.6% of controls (

<.005). In the OCS-01 twice-daily group, 62.7% of patients were pain-free on day 4 (

“Data on percentage of patients with absence of anterior chamber cells from earlier postoperative visits show a statistically significant difference favoring the once-daily OCS-01 group versus vehicle was achieved on day 8. The results for the pain assessment showed the proportion of patients who were pain-free increased in all groups as follow-up continued, but the difference was statistically significant between both OCS-01 groups and vehicle at days 8 and 15,” Donnenfeld said.

One patient in the vehicle group and one patient treated with OCS-01 twice daily withdrew from the study because of an adverse event. However, there were no significant ocular or systemic adverse events. Importantly, IOP ≥30 mm Hg was not observed in any patients at any follow-up visits nor did any patient have a ≥10 mm Hg increase from baseline IOP.

“The overall adverse event rate was higher in the vehicle group than in the OCS-01 groups, probably because the adverse events were procedure-related rather than treatment-related,” Donnenfeld said.

Donnenfeld noted that the potent activity, safety, and tolerability of OCS-01 observed in SKYGGN are consistent with results of another phase 2 trial investigating the novel steroid formulation as a treatment for diabetic macular edema. The latter study enrolled 144 patients and found a statistically significantly greater decrease in central macular thickness in patients treated with OCS-01 compared with vehicle-treated controls. There were no significant ocular adverse events in the OCS-01 group.

ASCRS

A vehicle-controlled phase 2 study investigating once- and twice-daily administration of a novel, preservative-free topical formulation of dexamethasone as treatment for pain and inflammation after cataract surgery met its primary endpoints.



Novel dexamethasone formulation shows efficacy and safety with once-daily use

Retina specialists Caesar Luo, MD, of Bay Area Retina Associates (Walnut Creek, CA) and S.K. Steven Houston III, MD, of Florida Retina Institute, share their outlooks on retina innovation in the "year of the eye" amid a global pandemic while speaking with 

ASRS

Retina specialists Caesar Luo, MD, of Bay Area Retina Associates (Walnut Creek, CA) and S.K. Steven Houston III, MD, of Florida Retina Institute, share their outlooks on retina innovation in the "year of the eye" amid a global pandemic.

Looking to the future of retina innovations


Alice Epitropoulos, MD, FACS, from The Cataract & Refractive Center of Ohio, speaks with 

 David Hutton on the key highlights from her presentation "Image quality or depth of field or both: Clinical outcomes from spherical aberration neutral monofocal toric IOL," during the 2020 ASCRS virtual meeting.



Disclosure: Dr. Epitropoulos is a consultant for Basuch + Lomb but has no financial interest in this presentation.

ICYMI: Alice Epitropoulos, MD, FACS, speaks on "Image quality or depth of field or both: Clinical outcomes from spherical aberration neutral monofocal toric IOL," during the 2020 ASCRS virtual meeting.

Image quality or depth of field — or both?


Dilraj Grewal, MD, associate professor of ophthalmology at Duke Eye Center/ director of grading at the Duke Reading Center, speaks with 

' David Hutton on his presentation "Evaluating the True 3-Year Recurrence Rate in Non-infectious Posterior Segment Uveitis Following an Injectable Fluocinolone Acetonide Insert," during the Inflammatory and Infectious Diseases Symposium of the virtual 2020 American Society of Retina Specialists (ASRS) meeting.

Dilraj Grewal, MD, speaks on his presentation "Evaluating the True 3-Year Recurrence Rate in Non-infectious Posterior Segment Uveitis Following an Injectable Fluocinolone Acetonide Insert," during ASRS 2020. 

Evaluating 3-year recurrence rate in non-infectious posterior segment uveitis post-FAi 

Justis P. Ehlers, MD, of the Cole Eye Institute at the Cleveland Clinic, speaks with 

' David Hutton on the key findings and take-aways from his presentation "Impact of baseline OCT characteristics on response to risuteganib for the treatment of intermediate age-related macular degeneration (AMD)" during the virtual 2020 American Society of Retina Specialists (ASRS) annual meeting.

Justis P. Ehlers, MD, speaks on the key findings and take-aways from his presentation "Impact of baseline OCT characteristics on response to risuteganib for the treatment of intermediate age-related macular degeneration (AMD)."

Impact of baseline OCT on response to risuteganib for treatment of intermediate AMD (ASRS 2020)

Daniel F. Kiernan, MD, FACS, speaks with 

®' David Hutton on the key findings and take-aways from his presentation, "Dexamethasone intracameral drug-delivery suspension for inflammation associated with vitreoretinal surgery," during the virtual 2020 American Society of Retina Specialists (ASRS) annual meeting.

Daniel F. Kiernan, MD, FACS, speaks on the key findings and take-aways of his presentation "Dexamethasone intracameral drug-delivery suspension for inflammation associated with vitreoretinal surgery."

Dexamethasone intracameral drug-delivery suspension in vitreoretinal surgery inflammation (ASRS 2020)



S.K. Steven Houston III, MD, discusses retina innovations in use in his practice, including the NGENUITY 1.4 upgrade from Alcon, and adapting to ever-changing operating room spacing and set-up in the COVID-19 environment, in an interview with

 Sheryl Stevenson during the virtual 2020 American Society of Retina Specialists (ASRS) meeting.

S.K. Steven Houston III, MD, discusses retina innovations in use in his practice, including the NGENUITY 1.4 upgrade from Alcon, and adapting to ever-changing operating room spacing and set-up in the COVID-19 environment

How one surgeon is integrating recent retina advances in COVID-19 (ASRS 2020)

®' Sheryl Stevenson on the take-away points from his presentation on diabetic retinopathy progression in anti-VEGF versus FA implant during the virtual 2020 American Society of Retina Specialists (ASRS) annual meeting, and how the topics from his talk may be applied day to day in retinal practice.


Caesar Luo, MD, shares the take-away points from his ASRS presentation, and how the topics from his talk may be applied day to day in retinal practice.

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