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INDUSTRY BRIEFS

PRESBYOPIA NEWS & NOTES

Five More Years of Patent Protection for Ocuphire

Ocuphire Pharma announced in early August that it has received patent protection through 2039 for Nyxol, its low-dose formulation of 0.75% phentolamine mesylate for presbyopia. This extended protection from the FDA extends the previous patent by 5 years.

“Last year we were granted a new U.S. Patent for presbyopia extending our existing patent estate into year 2039 and now we are very pleased with the issuance of this new patent for Nyxol in reversal of mydriasis,” said Mina Sooch, MBA, Ocuphire’s president and CEO, in a press release. She added that Ocuphire intends to submit a New Drug Application later this year to use Nyxol for reversal of mydriasis.

The good news for Ocuphire comes on the heels of the company’s positive phase 2 data from its VEGA-1 trial of Nyxol in presbyopia. In that study, Nyxol showed significant improvement in efficacy and durability of up to 12 hours in 63% of 150 patients randomized to receive the drug compared to placebo. Ocuphire has already reported preliminary data from phase 3 studies of Nyxol in both reversal of mydriasis and nyctalopia earlier this year. The company’s VEGA trial of Nyxol combined with low-dose 0.4% pilocarpine for presbyopia should start by the end of 2022.

FDA Approval for AcuFocus’ EDOF-IOL

AcuFocus has received FDA approval for its IC-8 Apthera extended depth of focus (EDOF) intraocular lens (IOL), which is the first and only nontoric IOL to provide EDOF in cataract patients with corneal astigmatism as great as 1.5D.

The approval is based on an Investigational Device Exemption study, which found that, at 12 months, subjects receiving the Apthera IOL maintained 2D of EDOF and showed an additional 0.91D of additional range compared to eyes implanted with monofocal IOLs at 0.2 logMAR threshold. The Apthera also provided superior uncorrected intermediate and near vision and equivalent distance vision and contrast sensitivity compared to control eyes with monofocal or monofocal/toric IOLs.

“We are delighted to receive FDA approval for our first-of-its-kind Apthera IOL,” said Al Waterhouse, president and CEO of AcuFocus in a press release. He noted further that the IOL “represents several firsts for surgeons and patients,” including being “the first extended depth of focus lens indicated for monovision, and the first non-toric IOL indicated for cataract patients with low amounts of corneal astigmatism.”

AcuFocus plans a commercial launch for this fall.

Rowe Named CEO at Eyenovia

Eyenovia announced in July the appointment of chief operating officer Michael Rowe as the company’s new CEO. Mr. Rowe has also been appointed to the company’s board of directors, alongside Drs. Ellen Strahlman and Ram Palanki, who were also announced as new board members. Mr. Rowe’s term of office began on August 1.

Dr. Sean Ianchulev, Eyenovia’s outgoing CEO and presiding chief medical officer, said in a press release, “For the past four years, we have benefited from Michael’s diverse ophthalmic industry experience, and we believe he is the ideal candidate to shepherd Eyenovia through this exciting new chapter in the company’s evolution.” Mr. Rowe added, “I look forward to helping maximize the value of our proprietary Optejet dispensing technology that I believe can become the new standard across a broad range of ophthalmic uses.”

Eyenovia has multiple medical therapeutics in development, including potential treatments for presbyopia and myopia progression and for reversal of mydriasis. MicroLine, its investigational pilocarpine ophthalmic preparation for presbyopia using the Optejet spray technology, is currently being tested in the phase 3 VISION-2 trial, which began enrolling last November. The company expects to report topline data in the coming weeks.

Atia Vision Obtains $42M in Funding

Atia Vision, Inc., which is developing a modular presbyopia-correcting IOL, announced on August 2 that it had closed on $42 million in Series E funding. Atia, which is a subsidiary of the Shifamed medtech incubator, obtained the funding from a group of venture capital groups led by Cormorant Asset Management, as well as angel investors from Shifamed. Series E is the final stage of funding for private startups, often accessed before going public.

“We are extremely pleased to close this round of financing with strong, continued support from our investors,” stated Mariam Maghribi, president and CEO of Atia Vision, in a press release. “We continue to execute on our clinical milestones and look forward to expanding our top-notch team.”

Atia’s modular IOL technology is implanted using conventional cataract techniques and features a fluid-filled base with an exchangeable fixed power front optic. The base changes shape in response to the eye’s natural accommodation process, providing a technology that enables the ophthalmologist to choose the ideal refractive option for each patient. ““We look forward to the impact this technology will offer patients suffering from cataracts and presbyopia, two of the largest segments of the ophthalmology market,” said Bichua Chen, Cormorant CEO and founder.

US Sales Approval for Lenstec’s Multifocal IOL

Lenstec announced at the end of July that its SBL (Segmented Bifocal Lens)-3 IOL received FDA approval for sale in the United States. The SBL-3 is an asymmetric refractive IOL that offers postcataract patients help with near, intermediate, and distance vision, using a patented 4-point fixation design, 0.25D power increments, and tolerances of ±0.11D from labeled power.

Dr. James Loden of Loden Vision Centers in Nashville, TN, who was a principal investigator in the Lenstec trial for FDA approval, said in a press release, “SBL-3 lens patients reported high quality distance and near vision, without the headache of severe dysphotopsia issues, and we had no complaints with computer vision.”

FDA approval was followed by the first successful implantation of the SBL-3 by Dr. Jeff Whitsett of Whitsett Vision in Houston. “Lenstec is proud to have a surgeon of Dr. Whitsett’s caliber be the first to implant our new ClearView [multifocal IOL] in the US,” said Jimmy Chacko, vice president of regulatory affairs at Lenstec, in a press release. “Years of clinical trial work by him and his staff helped catapult Lenstec into the presbyopia correction arena.” ■