This month, News in Review highlights selected papers from the original papers sessions at AAO 2018. Each was chosen by the session chair because it presents important news or illustrates a trend in the field. Only 4 subspecialties are included here; papers sessions will also be held in 5 other fields. For more information, see the Meeting Program, which you’ll find in your meeting bag, or the Mobile Meeting Guide.
No more bottles, no more drops. For glaucoma patients and their doctors, that dream came a bit closer to reality with the announcement that iDose (Glaukos), a travoprost-eluting intraocular implant, was safe and effective in patients with open-angle glaucoma or ocular hypertension during a phase 2 clinical trial.
“The early results are promising,” said trial investigator John P. Berdahl, MD, with Vance Thompson Vision in Sioux Falls, South Dakota. Reduction in intraocular pressure (IOP) was sustained, he said, and the procedure was safe.
How it works. The iDose implant is filled with a proprietary formulation of travoprost that allows for consistent drug delivery and implanted in the angle during a microinvasive procedure. It continuously elutes therapeutic levels of travoprost for at least 1 year. Upon medication depletion, a new iDose is implanted and the old one is removed.
Study specifics. This prospective double-masked multicenter trial enrolled 154 patients who were on 0-3 glaucoma medications. Unmedicated mean diurnal IOP was 21-36 mm Hg in the study eye. Patients were randomized to 2 different eluting models of the delivery system—iDose-slow (n = 54) and iDose-fast (n = 51). Controls (n = 49) received topical timolol ophthalmic solution 0.5% twice a day.
Findings. At 12 weeks, all study and control subjects achieved at least a 30% reduction in IOP. At 1 year, the subset of iDose eyes achieved a 33% reduction in IOP. Both the slow and fast models were equally efficacious. No adverse events, including hyperemia, were reported in either elution group.
Clinical implications. “Besides eliminating compliance issues, which are huge, we are glad to deliver the drug where we want it … inside the eye,” Dr. Berdahl said. “We know that topical drops are tough on the ocular surface, but we are willing to pay that price to lower IOP. Now we won’t have to.”
Having said that, he noted that with drops, patients are confident they are receiving the drug. But how would a patient know when the implant runs out of the medication? He suggested that an iDose replacement strategy might need to be implemented to ensure an uninterrupted drug supply.
Dr. Berdahl also noted that, for the study, the iDose was implanted in the operating room. But, he said, “I can envision the possibility of an in-office procedure” at some point in the future.
Continuing investigation. For the next phase, 1,000 patients are being recruited for the phase 3 trial, which is looking at similar endpoints: IOP lowering and safety. And the phase 2 follow-up will continue through 3 years. In the meantime, Glaukos has begun seeking regulatory approvals for iDose travoprost in European markets and Japan.
Interim Results of a Prospective, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Novel Sustained-Release Travoprost Intraocular Implants. When: Monday, Oct. 29, during the glaucoma original papers session (2:00-5:15 p.m.). Where: Room S404. Access: Free.
Relevant financial disclosures—Dr. Berdahl: Glaukos: C.
For full disclosures and the disclosure key, see below.
Full Financial Disclosures
Dr. Berhdal Alcon: C,L; Allergan: C,L; Avedro: C; Aurea Medical: C; Bausch + Lomb: C; Carl Zeiss: C,O; Clarvista: C; Dakota Lions Eye Bank: C; Envisia: C; Equinox: C,O; Glaukos: C,L; Imprimis: C,P; Iantech: C,O; Johnson & Johnson: C; New World Medical: C; Ocular Therapeutix: C; Omega Ophthalmic: C,O; Ocular Surgical Data: C,O; Orasis: C; RxSight: C; SightLife Surgical: C,O; Surface: C,O; Vittamed: C; Vance Thompson Vision: C,E,O; Verana Health: C,O.
Dr. Diel None.
Dr. Khurana Allergan: C; Clearside Biomedical: S; Genentech: C; Regeneron: C,S.
Dr. Terry Bausch + Lomb: P,L; Envisia: C; Moria: L.
||Consultant fee, paid advisory boards, or fees for attending a meeting.
||Employed by a commercial company.
||Lecture fees or honoraria, travel fees or reimbursements when speaking at the invitation of a commercial company.
||Equity ownership/stock options in publicly or privately traded firms, excluding mutual funds.
||Patents and/or royalties for intellectual property.
||Grant support or other financial support to the investigator from all sources, including research support from government agencies (e.g., NIH), foundations, device manufacturers, and/or pharmaceutical companies.
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