SPS-304 Glaucoma Medications | ASCRS
2020 ASCRS Virtual Annual Meeting

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Papers in this Session
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Effect of Topical Hypotensive Medications for Preventing Intraocular Pressure Increase after Cataract Surgery in Eyes with Glaucoma
Authors
Ken Hayashi, MD, PhD
Motoaki Yoshida, MD
Tatsuhiko Sato, MD
Shin-ichi Manabe, MD

Purpose
To compare the effects of a topical intraocular pressure (IOP)-lowering medication for preventing an IOP increase after cataract surgery in eyes with glaucoma.

Methods
One hundred sixty-five eyes of 165 patients with primary open-angle glaucoma or pseudoexfoliation glaucoma scheduled for phacoemulsification were randomly assigned to one of three groups to receive each medication immediately postoperatively: 1) prostaglandin F2α analogue (travoprost), 2) β-blocker (timolol maleate), or 3) carbonic anhydrase inhibitor (brinzolamide). IOP was measured using a rebound tonometer at 1 h preoperatively; at the end of surgery; and at 2, 4, 6, 8, and 24 h postoperatively. The incidence of eyes exhibiting a marked IOP increase to greater than 25 mmHg was compared among groups.

Results
At 1 h preoperatively and at the end of surgery, mean IOP did not differ significantly among groups. Mean IOP significantly increased between 4 and 8 h postoperatively, and then decreased at 24 h postoperatively in all groups (P<0.0001). Mean IOP was significantly lower in the brinzolamide group than in the travoprost or timolol group at 4, 6, and 8 h postoperatively (P≤0.0374), and did not differ significantly among groups at 2 and 24 h postoperatively. The incidence of an IOP spike was significantly lower in the brinzolamide group than in the travoprost and timolol groups (P=0.0029).

Conclusion
Brinzolamide more effectively reduces the short-term IOP increase after cataract surgery compared with travoprost or timolol maleate in eyes with glaucoma, suggesting that brinzolamide is preferable for preventing an IOP spike.
Efficacy of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Eyes with Prior SLT: Phase 3 Study Results at Primary Database Lock
Authors
Jacob W. Brubaker, MD
Michael R. Robinson, MD
Marina Bejanian, PhD
Jane Zhang, PhD
Miriam Kolko, MD, PhD
Michael Coote, MBBS

Methods
Two identical, double-masked, prospective, 20-month, phase 3 studies (n=594 and 528); patients with open-angle glaucoma or ocular hypertension, and open anterior angles on gonioscopy, were randomized to study eye treatment with BimSR 10 or 15 µg (Day 1, Weeks 16 and 32) or topical timolol 0.5% BID. Prior SLT was allowed if done >6 months before screening. Primary database lock was when all patients completed 12 weeks; primary endpoint was IOP lowering through 12 weeks. Kaplan-Meier analysis estimated the probability of no use of rescue medication after the 3rd administration. Analyses used pooled study data for the subgroup of patients with prior SLT in the study eye.

Results
For patients with prior SLT, baseline mean (SD) IOP (hour 0) was 24.3 (2.3) mmHg (n=28), 25.4 (3.1) mmHg (n=31), and 24.5 (2.6) mmHg (n=22) in the BimSR 10 µg, 15 µg, and timolol arms, respectively. Mean (SD) years from most recent SLT to Day 1 was 4.9 (3.0), 5.7 (3.4), and 3.8 (3.4), respectively. Mean (SD) average hour 0 IOP reduction from baseline over the primary efficacy period (Weeks 2, 6, 12) in patients with prior SLT was 6.6 (3.4) mmHg (BimSR 10 µg), 6.8 (2.9) mmHg (BimSR 15 µg), and 6.5 (3.1) mmHg (timolol). Among patients with prior SLT, the probability of no rescue for 360 days after the 3rd administration was 64% in the BimSR 10 µg arm and 77% in the BimSR 15 µg arm.

Conclusion
BimSR 10 and 15 µg effectively lowered IOP in patients with prior SLT. Patients with prior SLT were likely to remain treatment-free for one year after the 3rd administration of BimSR.
Efficacy and Safety of Bimatoprost SR (BimSR) in Phakic and Pseudophakic Eyes: Phase 3 Study Results at Primary Database Lock
Authors
Thomas R. Walters, MD
Blythe Monheit, MD, ABO
Miriam Kolko, MD, PhD
Margot L. Goodkin, MD, PhD
Suzanne Zheng, PhD
Michael R. Robinson, MD

Purpose
BimSR is a biodegradable intracameral implant providing slow, sustained bimatoprost release to lower intraocular pressure (IOP). The larger anterior angles in pseudophakic eyes could potentially affect the efficacy/safety profiles of an intracameral implant. This analysis evaluated the efficacy and safety of BimSR in phakic and pseudophakic eyes.

Methods
Two identical, double-masked, 20-month, phase 3 studies (n=594 and 528); patients with open-angle glaucoma or ocular hypertension were randomized to study eye treatment with BimSR 10 or 15 µg (Day 1, Wks 16 and 32) or topical timolol 0.5% BID (tim). Pooled study data from primary database lock when last patient completed Wk 12 were analyzed. Primary endpoint was IOP lowering through Wk 12. Mean weighted average Hr 0 IOP reductions from baseline were calculated over Wks 2, 6, and 12. Kaplan Meier analysis estimated probability of no use of rescue medication. Safety measures included adverse events. Subgroup analysis evaluated outcomes by study eye lens status (phakic/pseudophakic).

Results
Baseline mean IOP (Hr 0) was 24.6 (n=287), 24.7 (n=272), and 24.8 (n=278) mmHg for phakic eyes and 24.1 (n=87), 24.4 (n=101), and 24.0 (n=95) mmHg for pseudophakic eyes in the BimSR 10 µg, 15 µg, and tim groups, respectively. Mean weighted average Hr 0 IOP reductions from baseline over 12 weeks were 7.5, 7.7, and 7.0 mmHg for phakic eyes and 7.2, 7.4, and 6.8 mmHg for pseudophakic eyes in the BimSR 10 µg, 15 µg, and tim groups, respectively. Probability of no rescue for 360 days after 3rd administration in the BimSR 10 and 15 µg groups was 81% and 86% for phakic eyes, 77% and 82% for pseudophakic eyes. The safety profile was similar for phakic and pseudophakic eyes.

Conclusion
BimSR 10 and 15 µg both met the primary endpoint of noninferiority to timolol BID in IOP lowering through Week 12. BimSR effectively lowered IOP and provided sustained IOP lowering in both phakic and pseudophakic eyes. The safety profile of BimSR was acceptable and similar in phakic and pseudophakic eyes.
Results of Phase 3 Study of Bimatoprost SR at Primary Database Lock: IOP Lowering in Patients with Prior Topical Therapy and Responder Rates
Authors
E. Randy Craven, MD, ABO
Michael R. Robinson, MD
Marina Bejanian, PhD
Qiang Guo, PhD
Felipe Medeiros, MD

Purpose
To evaluate efficacy of an intracameral, sustained-release bimatoprost implant (Bimatoprost SR, BimSR) in lowering mean intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT) previously treated with 0, 1, or ≥2 topical IOP-lowering medications; and the proportion of patients achieving specific levels of IOP lowering.

Methods
In 2 identical, 20-month, phase 3 studies (n=594, 528), patients with OAG/OHT and open angles on gonioscopy were randomized to study eye treatment with BimSR 10 or 15 µg (Day 1; Week 16; Week 32) + vehicle eyedrops BID or sham + timolol 0.5% eyedrops BID. Primary database lock: completion of Week 12 visit by all patients. Primary endpoint: IOP lowering through Week 12. IOP lowering at Hour 0 (8 AM ± 1 hour) and rescue medication use were evaluated after stratification by IOP-lowering medication count at screening, before washout. Patients (%) achieving ≥20%, ≥25%, ≥30%, ≥35%, and ≥40% IOP lowering at Hour 0 were evaluated at Weeks 2, 6, and 12. Analyses used the pooled study dataset.

Results
Baseline mean IOP was 24.6 (BimSR 10 µg), 25.4 (BimSR 15 µg), and 24.8 (timolol) mmHg. After the first administration, mean average IOP over 12 weeks was similar among subgroups on 0, 1, or ≥2 medications at screening for both BimSR 10 µg (17.2, 17.1 and 17.0 mmHg) and 15 µg (17.1, 16.8, and 17.5 mmHg), and comparable to the control/timolol group (17.7, 17.5, and 17.9 mmHg), respectively. The probability of being medication-free for 1 year after the 3rd administration of BimSR was high (≥74%), regardless of prior medication count. Through Week 12, the proportion of patients achieving different target levels of IOP reduction from baseline was consistently larger for BimSR than timolol.

Conclusion
The primary endpoint was met. BimSR 10 and 15 µg effectively reduced IOP from baseline and the vast majority of patients were medication-free at 1 year after the third implant, whether they previously used 0, 1, or ≥2 glaucoma medications. BimSR responder rates were high: ≥47% of patients had ≥30% IOP reduction from baseline at weeks 2, 6, and 12.
Efficacy of Bimatoprost SR in Patients Stratified By Baseline IOP (less than or equal to 25 or >25 mmHg): Phase 3 Study Results at Primary Database Lock
Authors
Robert N. Weinreb, MD
Miriam Kolko, MD, PhD
Kevin Wang, PhD
Jeen Liu, PhD
Michael R. Robinson, MD
Marina Bejanian, PhD

Purpose
Bimatoprost SR, a biodegradable intracameral implant in development, slowly releases bimatoprost to lower IOP. The purpose of this analysis was to evaluate the IOP-lowering efficacy of Bimatoprost SR compared with topical timolol in eyes with open-angle glaucoma (OAG) or ocular hypertension (OHT) and baseline IOP of ≤25 or >25 mmHg.

Methods
In 2 identical, double-masked, 20-month, phase 3 studies (n=594 and 528), OAG/OHT patients with confirmed open angles on gonioscopy were randomized to study eye treatment with Bimatoprost SR 10 or 15 µg (Day 1, Weeks 16 and 32) or topical timolol 0.5% BID (timolol). Pooled study data from primary database lock, when last patient completed Week 12 visit, were analyzed. The primary efficacy endpoint was IOP lowering through Week 12. Per protocol, the randomization stratified patients by baseline IOP (Hour 0) of <25 or ≥25 mmHg. The present analysis evaluated mean weighted average Hour 0 IOP reductions from baseline over visits at Weeks 2, 6, and 12 for patients in these stratifications.

Results
Baseline mean [SD] IOP at Hour 0 was well balanced among treatment groups (Bimatoprost SR 10 µg: 24.5 [2.6] mmHg; Bimatoprost SR 15 µg: 24.6 [2.7] mmHg; timolol: 24.6 [2.6] mmHg). Mean weighted average Hour 0 IOP reductions from baseline over 12 weeks were 6.7 mmHg, 6.8 mmHg, and 6.4 mmHg for patients with baseline IOP ≤25 mmHg (n=795), and 9.2 mmHg, 9.4 mmHg, and 8.5 mmHg for patients with baseline IOP >25 mmHg (n=326), in the Bimatoprost SR 10 µg, Bimatoprost SR 15 µg, and timolol groups, respectively. Bimatoprost SR 10 and 15 µg met the prespecified criteria for noninferiority to timolol both in patients with baseline IOP of <25 mmHg and in those with baseline IOP of ≥25 mmHg.

Conclusion
Bimatoprost SR 10 and 15 µg were noninferior to timolol BID in IOP lowering through Week 12, both in patients with baseline IOP ≤25 mmHg and in patients with baseline IOP >25 mmHg. In patients with baseline IOP >25 mmHg, Bimatoprost SR lowered IOP on average by 9–10 mmHg, similar to the efficacy of fixed combinations of two topical medications.
Safety & Efficacy of Intracameral Steroid, NSAID, and Antibiotic Vs Topical Medications for Cataract Surgery and Supraciliary Microstent
Authors
Michael D. Greenwood, MD
Jacob W. Brubaker, MD

Purpose
To evaluate the safety and efficacy of intracameral administration of a steroid, antibiotic, and NSAID compared to topical steroid, antibiotic and NSAID during cataract surgery and placement of a supraciliary shunt in preventing postoperative inflammation, pain, cystoid macular edema (CME), and endophthalmitis

Methods
Patients underwent cataract surgery plus placement of a supraciliary shunt (Cypass, Alcon). At the end of the procedure, the intracameral group received an injection of dexamethasone-moxifloxacin-ketoralac (DMK, Imprimis) in the anterior chamber. and used 1 drop antibiotic, steroid, and NSAID for 1 month. The topical medication group, had an intracameral injection of moxifloxacin, and then took a tapered topical steroid and a NSAID that was used for 1 month. Data were recorded preoperatively and 1 day, 1 week, 1 month, and 3 months postoperatively. Primary outcomes included the number of glaucoma medications, intraocular pressure (IOP), and IOP spikes of at least 15 mm Hg from baseline

Results
3 Month Results included IOP lowering, medication reduction, and IOP spikes. A total of 35 eyes were in the topical group, and 46 eyes in the IC group. Pre-op IOP in the topical group was 16.91 ± 4.27 and 14.52 ± 6.51 at 3 months. The pre-op IOP in the IC group was 19.70 ± 7.27 and 12.93 ± 3.19 at 3 months. This was not statistically significant. Pre-op meds were 2.46 ± 1.07 in the topical group and 1.28 ± 1.07 in the IC group. This was statistically significant. At 3 months, the topical group was on 0.52 ± 0.83 medications and the IC 0.25 ± 0.59 medications. This was not statistically significant. There was 1 IOP spike at POD1 and POM1 in the topical group and no IOP spikes in the IC group

Conclusion
Cataract Surgery plus CyPass resulted in significant IOP lowering and decreased medication burden up to 6 months Intracameral steroid, antibiotic, and NSAID is a safe and effective method of delivering medications, with results similar or better than topical medications
Safety and Efficacy of Intracameral Vs Intravitreal Vs Topical Steroid, Antibiotic, and NSAID after Cataract and Trabecular Bypass Surgery
Authors
Jacob A. Evans, MD
Michael D. Greenwood, MD
Mitch J. Ibach, OD
Ramu G. Sudhagoni, PhD
John P. Berdahl, MD

Purpose
To evaluate the safety and efficacy of an anterior chamber injection, when compared to intravitreal injection and to topical application of antibiotic, steroid, and non-steroidal anti-inflammatory drug (NSAID) medications at the time of cataract surgery with microbypass stent placement.

Methods
All eyes underwent cataract surgery with trabecular microbypass stent. 132 eyes received injection of dexamethasone-moxifloxacin-ketorolac into the anterior chamber (AC DMK) then once a day topical combination prednisolone, antibiotic, and NSAID; 234 eyes received pars plana intravitreal injection of triamcinolone-moxifloxacin-vancomycin (PP TMV) then once a day combination drops; and 249 eyes received a traditional prednisolone, antibiotic, and NSAID drop regimen. Data was recorded preoperatively and post-operatively at 1 day, 1 week, 1 month, and 3 months. Primary outcomes included number of glaucoma medications, intraocular pressure (IOP), and IOP spikes ≥15 mmHg from baseline.

Results
Three months postoperatively, the mean reduction in glaucoma medications was 0.69 in the AC DMK group, 0.24 in the PP TMV group, and 0.80 in the topical group 3 months after surgery (AC DMK vs PP TMV p=0.0002, AC DMK vs topical p=0.598, PP TMV vs topical p<0.0001). Reduction in IOP was 2.0 mmHg in the AC DMK group, 2.6 mmHg in the PP TMV group, and 3.6 mmHg in the topical group (p=0.0699) with a mean final IOP of about 15 in each group. There was a pressure spike at 4.03% of all postoperative office visits in the AC DMK group, 5.66% in the PP TMV group, and 3.71% in the topical group (p=0.089). There were no cases of endophthalmitis or retinal detachments.

Conclusion
Postoperatively at 3 months, all groups had similar IOP reduction, percent reduction, final IOP, and cumulative IOP spikes. AC DMK and topical groups showed greater reduction in glaucoma medications than PP TMV. AC DMK is safe and effective for patients with glaucoma undergoing cataract surgery with trabecular microbypass stent insertion.
Evaluating Safety, Tolerability and Efficacy of an Intracameral Hydrogel-Based Travoprost Implant in Subjects with Glaucoma - Phase 1 Trial
Authors
Thomas R. Walters, MD
Damien Goldberg, MD
Elizabeth M Braun, PhD
Srilatha Vantipalli, PhD
Jamie Lynne Metzinger, MSc, MPH
Michael H. Goldstein, MD, MBA

Purpose
OTX-TIC (travopost intracameral implant) is a resorbable hydrogel-based implant delivering travoprost intracamerally in a sustained-release fashion in the anterior chamber. Here we evaluate the safety, tolerability and efficacy of a single OTX-TIC implant, in subjects with primary open-angle glaucoma or ocular hypertension in a Phase 1 study.

Methods
Prospective, multicenter open-label Phase 1 trial is ongoing. Diurnal intraocular pressure (IOP) (8am, 10am, 4pm) is measured at Baseline, Days 14, 42, 85, Months 4, 6 and 4-week follow-up after (8am only). Study eye received intracameral placement of OTX-TIC. Non-study eye was treated with topical travoprost (Travatan Z). Safety evaluations include: adverse event collection, slit lamp biomicroscopy, gonioscopy, endothelial cell count with specular microscopy, pachymetry, optical coherence tomography (OCT) imaging, and visual field tests. Implant is visualized at every visit. Three cohorts: low dose(n=5), high dose (n=4) and fast-degrading low dose (n=2; enrolling) are being evaluated.

Results
Mean IOP change from baseline were decreased as early as two days following implantation measured, with differences up to 7-10 mmHg recorded in the low (up to 15 months) and high dose (up to 6 months) cohorts. No differences in IOP control compared to non-study eye were noted. No differences in mean IOP change from baseline noted between low and high dose cohorts (both fully enrolled) at 6 months. No changes in endothelial cell counts or corneal thickness noted. Most common adverse events reported include low grade inflammation and peripheral anterior synechiae. Implant generally degrades in 5-7 months. No implant movement noted.

Conclusion
OTX-TIC IOP lowering similar to topical prostaglandin drop. Implant has generally been well tolerated with a favorable safety profile. It has remained localized to site of insertion. Implant resorbs in 5-7 months (low and high dose cohorts) with consistent IOP-lowering effect with a single insert observed for over a year in at least one patient.

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