FDA approves updated femtosecond laser for refractive surgery

Zeiss Medical Technology announced that the FDA approved its VISUMAX 800 with SMILE pro software, which the company states “enables faster treatment, creating the lenticule in less than 10 seconds.” According to the company’s press release, workflow enhancements of the system for SMILE refractive surgery include the CentraLign centration aid, OcuLign cyclotorsion adjustment, and VISULYZE user nomograms.

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Positive topline results from Phase 3, first-in-class dry eye disease studies

Alcon announced positive topline results from its two Phase 3 pivotal trials evaluating AR-15512 for treatment of signs and symptoms of dry eye disease. According to the company’s press release, AR-15512 is a topical transient receptor potential melastatin 8 agonist and a first-in-class candidate to treat dry eye disease. Both studies, which collectively enrolled more than 930 participants, met the primary endpoint of a statistically significant proportion of patients achieving a 10-mm or more increase in unanesthetized Schirmer’s score. The company also reported rapid onset of action and sustained tear production associated with AR-15512 compared to vehicle. The drug was well tolerated with no serious ocular adverse events.

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Rare Disease Designation granted for investigational gene therapy

Atsena Therapeutics announced that it has received a Rare Pediatric Disease Designation from the FDA for its investigational gene therapy that would treat patients with Leber congenital amaurosis caused by biallelic mutations of GUCY2D (LCA1). The company’s gene therapy is currently in a Phase 1/2 clinical trial. The gene therapy has already been granted a Regenerative Medicine Advanced Therapy and Orphan Drug Designation from the FDA. Positive 12-month safety and efficacy data will be presented by the company in February. Clinically meaningful improvements in vision were seen with the highest dose, the company reported.

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Positive interim data for investigational Stargardt disease treatment

Alkeus Pharmaceuticals announced positive interim data from its clinical trial investigating gildeuretinol for Stargardt disease. According to the company’s press release, the gildeuretinol treatment was shown in the ongoing study to halt disease progression in the first three teenage participants who have been enrolled and treated so far. The treatment duration for these patients is 2–6 years. The company reported that this trial is the first clinical trial for early stage Stargardt disease. Participants have early signs visible on retinal imaging but not yet symptomatic vision loss. Participants are matched in the open-label study with their untreated sibling with Stargardt disease and identical mutations. The primary endpoint of the study is progression after the first 2 years of treatment. The company reported that after this initial treatment period, participants can continue to receive the oral gildeuretinol treatment for extended periods. The study currently has 5 patients and none have shown signs of disease progression while on treatment.

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First patient dosed in Phase 2 trial for DME treatment

EyePoint Pharmaceuticals has begun dosing patients in its Phase 2 clinical trial of EYP-1901 for treatment of DME. According to the company, this investigational sustained delivery of vorolanib is a selective tyrosine kinase inhibitor within the bioerodible Durasert platform. The study is randomized, controlled, single masked, and taking place in patients with DME who were previously treated with standard anti-VEGF therapy. The trial has three arms (two arms are different intravitreal doses of EYP-1901 and one arm is aflibercept/control). The study plans to enroll about 25 patients. The primary efficacy endpoint is time to first supplemental aflibercept injection up to 24 weeks. Secondary endpoints are safety, change in BCVA, change in central subfield thickness, and change in diabetic retinopathy severity scale over time.

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Research program established to investigate whole eye transplant

The Advanced Research Projects Agency for Health within the U.S. Department of Health and Human Services is establishing the Transplantation of Human Eye Allografts program. This program, according to the agency’s press release, will move research forward toward transplantation of whole human eyes with the intent to restore functional vision to the blind and visually impaired.

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ASCRS news and events

• ASCRS Annual Meeting: Tier 1, early bird pricing for the ASCRS Annual Meeting has been extended through January 22. The Preview Program for this meeting has also been posted. Learn more about the premier educational and networking event for anterior segment surgery here.
• Eyecelerator @ ASCRS: Eyecelerator, a partnership between ASCRS and the American Academy of Ophthalmology, is bringing back The Winning Pitch Challenge to Eyecelerator @ ASCRS, April 4, in Boston, Massachusetts. Submissions for The Winning Pitch Challenge are being accepted now through February 2. Cash prizes for winners are worth up to $25,000. Find more information on submissions here.

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Research highlights

• Pooled analysis of two identical prospective, randomized, vehicle-controlled studies evaluated the efficacy of topical pilocarpine HCl 1.25% for treatment of presbyopia in patients with or without history of LASIK/PRK. According to the study published in the Journal of Cataract & Refractive Surgery, there were 39 patients in the pilocarpine group and 41 in the vehicle group who had history of prior refractive surgery. The study found that the responder rate of a 3 or more line improvement in DCNVA on day 30 at 0.25, 0.5, 1, 3, 6, 8, and 10 hours were 16.7%, 38.9%, 41.7%, 37.8%, 16.2%, 13.9%, and 8.3%, respectively, with pilocarpine and 0.0%, 2.6%, 10.5%, 5.1%, 7.7%, 2.6%, and 0.0%, respectively, with vehicle. The responder rate in the LASIK/PRK subgroup was significantly higher with pilocarpine than vehicle at hours 0.25, 0.5, 1, and 3. The authors noted no significant difference in responder rates among patients with or without prior refractive surgery who received pilocarpine. The authors concluded that the pilocarpine improved DCNVA in patients with presbyopia regardless of history of laser vision correction, with similar efficacy in both groups.
• Investigators conducted a medical record chart review of 26,470 consecutive eyes that had immediately sequential bilateral cataract surgery or refractive lens exchange with multifocal IOLs to evaluate the relationship between preop angle kappa and postop refractive accuracy, visual outcomes, and patient satisfaction. The study, published in the Journal of Refractive Surgery, found “no clinically meaningful relationship between preoperative angle kappa and postoperative sphere, cylinder, [spherical equivalent], and [defocus equivalent].” The authors also did not find a “clinically meaningful relationship between preoperative angle kappa and postoperative UDVA, postoperative satisfaction for near, intermediate, and distance vision, or for recommending the MIOL surgery to friends and relatives.” They concluded that preop angle kappa “does not have a predictive clinical impact on postoperative MIOL visual outcomes, refractive accuracy, or subjective patient satisfaction” and thus “angle kappa as a single variable cannot be used to determine MIOL candidacy.”

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Product news

• Eyenovia announced that it re-acquired the rights to MicroPine, an investigational microliter ophthalmic spray of atropine delivered via Optejet (Eyenovia), in the U.S. and Canada.
• VEVYE (cyclosporine ophthalmic solution, 0.1%, Harrow) for treatment of signs and symptoms of dry eye disease is now available in the U.S.
• Iridex launched its Iridex 532 and Iridex 577 lasers in the U.S.

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