First implantations for clinical trials for investigational IOLs

Rayner announced that the first implantations of two “pivotal market access studies” have taken place: one in China for the RayOne Trifocal IOL and one in the U.S. for the RayOne EMV Toric. In China, the trial is a prospective, multicenter, randomized, parallel-controlled, evaluator-masked, non-inferiority clinical trial that, according to the company’s press release, will evaluate safety and efficacy of the RayOne Trifocal in aphakic patients. This study is intended, if successful, to bring this IOL technology to the Chinese market. The second study taking place in the U.S. with the RayOne EMV Toric IOL, which has an Investigational Device Exemption from the FDA, is prospective, multicenter, randomized, masked, and active controlled. If successful, it will support a pre-market approval submission to the FDA. The non-toric RayOne EMV received FDA approval in 2021.

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Phase 2 clinical trial for wet AMD treatment completes enrollment

Adverum Biotechnologies announced that it completed enrollment for its Phase 2 clinical trial of ixoberogene soroparvovec for treatment of wet AMD. The trial will evaluate efficacy and safety of the therapy in about 60 patients who were randomized to receive one of two different doses. The company’s press release explained that participants will also be randomized into four prophylactic regimens: 40 receiving one of two local ocular corticosteroid regimens and 20 receiving one of the local corticosteroid regimens and oral prednisone. This latter part of the study, the company stated, will inform whether to include an oral prophylactic in future trials.

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Two-year results from trial showcase vision gains in wet AMD at extended aflibercept dosing intervals

Regeneron announced positive 2-year results from its pivotal trial investigating aflibercept 8 mg in patients with wet AMD. Patients were randomized to a 12-week or 16-week dosing interval after an initial 3-month period where doses were administered monthly. The company’s press release stated that 88% of patients were on a 12-week or longer dosing interval at the end of 2 years, and 71% met criteria to have an even longer dosing interval (47% 20- or more week intervals, 28% 24-week intervals). The company reported that visual gains and safety of aflibercept 8 mg was consistent with that of EYLEA (aflibercept) 2 mg on an 8-week dosing regimen. Earlier this year the FDA issued a Complete Response Letter for the Biologics License Application the company filed for aflibercept 8 mg for wet AMD, DME, and diabetic retinopathy, requesting manufacturing data and other information from Regeneron and the manufacturing company. In a separate press release, Regeneron stated that it planned to submit this information to the FDA by mid-August and expects a response from the FDA within the third quarter of 2023.

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Acquisition update

Eyenovia entered into an agreement with Formosa Pharmaceuticals to acquire exclusive rights in the U.S. to distribute and sell APP13007 (clobetasol propionate ophthalmic nanosuspension), 0.05%, intended for the treatment of inflammation and pain reduction. This compound is under FDA review with a PDUFA action date set for March 4, 2024. Eyenovia stated in a press release that it plans to evaluate clobetasol formulations in its Optejet dispensing platform to potentially treat dry eye.

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ASCRS news and events

• ASCRS Annual Meeting: The call for submissions for the 2024 ASCRS Annual Meeting is going on now through October 9. Find submission details here.
• ASCRS Satellite CME: Three clinical programs, a supplement to the main programming at the ASCRS Annual Meeting, are now available on demand. Find ASCRS Satellite CME offerings here.
• ASCRS OSD Algorithm: The ASCRS Cornea Committee has launched a new program, building upon the experience of the ASCRS Preoperative OSD Algorithm. Join committee members as they provide a guided educational tour of the ASCRS Preoperative OSD Algorithm. The first of five tours is available now.

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Research highlights

• A case-control study and prospective cohort study published in the Journal of Cataract & Refractive Surgery sought to explore clinical indicators that might help predict patient perceived pain during second eye cataract surgery. According to the study, before surgery vessel area density (VAD) and vessel skeleton density (VSD) were obtained using OCT angiography of the iris. After surgery, patients’ perception of intraoperative pain was evaluated at 1 hour, 3 hours, and 24 hours postop. A total of 70 patients were enrolled in the case-control study; the authors reported that pain scores for the second eye in the surgery group that received local anesthesia were significantly greater than when the first eye underwent surgery. Preoperative iris VAD in the second-eye group affected perioperative pain scores, the authors reported. One hundred and twenty-four patients were enrolled in the second-eye group of the prospective cohort study; preop iris VAD and the time interval between first eye and second eye surgeries were evaluated as they related to pain perception. These factors combined, the authors reported, had a negative predictive value and a positive predictive value for “moderate pain or above” of 0.85 and 0.29, respectively. The authors concluded that iris VAD and the time between first and second eye surgery can be used to predict timing of second-eye surgery to avoid perception of intraoperative pain.
• Efficacy and patient preference of a “dropless” postop regimen following cataract surgery vs. a conventional topical regimen were compared in a prospective, contralateral eye study published in the journal Clinical Ophthalmology. Patients were randomized to receive an intracanalicular dexamethasone insert and intracameral phenylephrine 1%/ketorolac 0.5% and moxifloxacin (50 μg) or topical moxifloxacin 0.5%, ketorolac 0.5%, and prednisolone acetate 1.0% QID; the participants’ second eye received the opposite postop regimen. According to the authors, the proportion of patients with no pain was similar among both groups at all postop visits, and there was no statistically significant difference in the summed ocular inflammation score between the study eyes and control eyes. Nearly 95% of patients preferred the “dropless” regimen compared to the topical therapy. There was no significant difference in IOP (except at week 1), and mean CDVA was similar at all postop visits, the authors reported.

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Product news

• The FDA approved Lupin Limited’s Abbreviated New Drug Application to market Bromfenac Ophthalmic Solution, 0.09%, a generic equivalent of Bromday Ophthalmic Solution, 0.09% (Bausch + Lomb).

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