For Retinitis Pigmentosa With Severe Vision Loss, Mogenry Is at the FDA and 12 of 37 Open Trials Allow Hand-Motion Vision

Counting fingers, hand motion and light perception are the 3 levels an eye doctor uses once someone can no longer read the top line of an eye chart. Everyone treated in the main trial of Mogenry started at one of those levels. The trial took only adults whose retinitis pigmentosa had left the study eye seeing worse than 20/1600.

That detail decides what this news means for you or for someone you help care for. When vision is in that range, Mogenry is a therapy under FDA review that was tested in people with vision like yours. When vision is better than that, no controlled trial has tested it yet, and a different study may be the closer fit.

News about Mogenry tends to repeat 3 points, which are that it works for any gene, takes 1 injection and needs no surgery. Less has been written about who was in the trial and what the measured gain means from that starting point. Less still covers which open studies would take the same level of vision, and this guide counts them.

What Is Mogenry, and When Will the FDA Decide on It for Retinitis Pigmentosa?

Mogenry (sonpiretigene isteparvovec, formerly MCO-010) is a one-time injection into the eye that Nanoscope Therapeutics has asked the FDA to approve for retinitis pigmentosa with severe vision loss. Nanoscope announced on September 9, 2026 that the FDA had accepted the application. Its chief executive said on October 1, 2026 that a potential approval is expected in the first half of 2027.

No exact decision date has been published by Nanoscope. Its statements also differ on whether the FDA granted a faster priority review, which its chief executive has described and its September announcement does not mention. The Foundation Fighting Blindness reported on September 18, 2026 that the company had requested one. The Mogenry decision page will carry the date once a primary source states it.

Retinitis pigmentosa, often shortened to RP, slowly destroys the rods and cones, the cells that catch light. MedlinePlus, the National Library of Medicine's patient site, says changes in more than 130 genes can cause it. Mogenry does not repair any of those genes. It uses a harmless virus to deliver a light-sensing protein to bipolar cells, the nerve cells that sit just behind the rods and cones. A 2025 paper in Molecular Therapy describes those cells as preserved in RP.

Because the target is a surviving cell and not a faulty gene, the therapy is built to work whichever gene caused the disease. Researchers call that approach gene-agnostic. "Our approach is indifferent to which gene caused the degeneration," Samarendra Mohanty, Nanoscope's president and chief scientific officer, told the Foundation Fighting Blindness. The injection goes into the gel in the middle of the eye and is called an intravitreal injection. The Institute for Clinical and Economic Review, an independent group that assesses new treatments, reported that experts expect most eye doctors could give it in an office.

Mogenry's main trial, called RESTORE, enrolled only adults whose study eye saw worse than 20/1600 and whose other eye saw no better than 20/800. Those cutoffs are written in the trial's ClinicalTrials.gov record, NCT04945772. The record shows 27 participants at 6 sites in the United States and Puerto Rico, with one eye treated in each person.

Social Security counts a person as blind when the better eye cannot be corrected past 20/200. The RESTORE entry line of 20/1600 is 8 times that figure, by simple division. An ordinary eye chart cannot measure vision that low, so the trial used a computer test called the Freiburg test.

A study of that test, published in 2009, put numbers on those levels. People at counting fingers averaged 1.98 on the logMAR scale, where a higher number means worse vision, and people at hand motion averaged 2.28. Light perception was too low for the test to measure at all. RESTORE took only vision worse than 1.9 logMAR, so its participants were at about the counting-fingers level or below it. The institute's final report gives the average starting vision as 2.2 logMAR, which it describes as seeing hand movement.

The Institute for Clinical and Economic Review estimated in May 2025 that about 12% of people with RP reach this stage. Nanoscope's own announcement speaks of more than 100,000 people with RP, over 25,000 of them legally blind. Those 2 groups are not the same size, and the trial tested the smaller one.

Three invented examples, none of them real patients, show where those lines fall.

Hand-motion vision and no gene found

A woman of 58 can tell when a hand moves in front of a bright window, and 2 rounds of genetic testing found no cause. She matches the people RESTORE enrolled, and gene-specific studies have no place for her. Most other studies also require more vision than she has.

Tunnel vision at 20/50 with an RPGR result

A man of 31 reads most of an eye chart through a narrow tunnel and knows his RP comes from the RPGR gene. Nobody with vision like his was in RESTORE. Christine Kay, a retina specialist who presented Mogenry's 4-year data, told Modern Retina in September 2026 that patients with good acuity would not benefit.

Central vision near 20/400

A retired teacher sees about 20/400 in her better eye, which is past legal blindness and still far better than 20/1600. No trial with a comparison group has tested Mogenry in vision between 20/200 and 20/1600. A different gene therapy, RTx-015, is recruiting people in that range at US sites, as the trial count further down shows.

What Did Mogenry Do in the RESTORE Trial?

In RESTORE, the dose Nanoscope plans to sell improved vision by an average of 0.337 logMAR after 52 weeks, against 0.050 for people given a pretend injection. Both doses beat the pretend injection at 52 weeks, which was the trial's main test. At 76 weeks the higher dose still did. The lower dose's lead at that point was too small to rule out chance, which researchers call not statistically significant.

A gain of 0.3 logMAR is the size that the Institute for Clinical and Economic Review treats as meaningful, and Nanoscope says Iceland's medicines agency endorsed it. In plain terms it is a doubling of sharpness. Starting from 20/1600, a doubling reaches about 20/800, which is still 4 times past the legal blindness line.

Company materials describe the same gain as 3 lines or 15 letters on an eye chart. That is a translation into eye-chart terms, because these participants could not read a standard chart when they started. For someone at the hand-motion average of 2.28, a gain of 0.3 reaches 1.98, the counting-fingers average in the 2009 Freiburg study. That step is this site's own calculation from the 2 sources, and no trial report states it.

Averages also hide a wide spread from one person to the next. The institute's final report says 8 of the 18 treated people had no detectable change in sharpness at week 52. Nanoscope reported that 7 of the 18 treated people, or 39%, had gained 0.3 logMAR or more at week 52. By week 76 the count was 10 of 18, or 56%. The institute's final report counts 1 of the 9 pretend-injection participants as gaining that much at week 52. It notes that this person's vision had been measured incorrectly, against the study's rules. It also reports that the share of treated people with that gain fell to 28% at week 100.

The pretend-injection group's average also moved slightly, by 0.050 at week 52 and 0.078 at week 76. Nanoscope's table gives each figure a margin of error of about 0.07, which is about as large as the changes themselves. Subtracting the week 52 figure leaves 0.287 for the higher dose and 0.332 for the lower dose, by this site's own subtraction. With 9 people in each group, a small shift in 1 or 2 scores moves an average.

Nanoscope's position is that RESTORE met its main goal and that the gains lasted. It reported in October 2025 that treated patients kept an average gain of about 0.3 logMAR through week 152. People from the pretend-injection group were not followed in that longer study, so the 3-year figure has nothing to be compared with.

On safety, Nanoscope reported no serious side effects in the treated groups. The most common problems were inflammatory cells in the front of the eye and raised eye pressure. The first affected 44% of treated people against 22% given the pretend injection, and the second 39% against 11%. The company said these cleared up or were controlled with medicine applied to the eye.

An outside review reached a mixed verdict when the Institute for Clinical and Economic Review rated the evidence "promising but inconclusive" in May 2025. It pointed to the 27 participants, the wide spread in responses and secondary results that had not been made public. Its independent panel still voted 10 to 2 that the evidence showed a net benefit over usual care. David Rind, the institute's chief medical officer, called the underlying science "remarkable" while listing uncertainties about how well and how long it works.

One more fact belongs beside those results, and it concerns the trial's main measure. Nanoscope said in January 2024 that it had made sharpness of vision the trial's main measure again while the trial was still running. Doctors call that measure visual acuity, and the company said the change followed discussions with regulators. The company says the change matched the study's original aims. It also says the FDA had told it that such a measure could be appropriate for people with very low vision.

Mogenry vs Luxturna for Retinitis Pigmentosa, Side by Side

Luxturna, approved on December 19, 2017, is the gene therapy most people with RP have heard of. It and Mogenry sit at opposite ends of the disease. Luxturna's label requires changes in both copies of a single gene, RPE65, and retinal cells that are still alive. Mogenry was tested where most of those cells are gone.

Luxturna reaches only a small share of people with RP. A 1998 study in the Proceedings of the National Academy of Sciences found RPE65 changes in about 2% of people with the recessive form of RP. The comparison also shows a gap in the middle. Someone with no RPE65 change and vision between 20/60 and 20/1600 falls outside what either trial tested.

Which Open Retinitis Pigmentosa Trials Take Hand-Motion Vision?

ClinicalTrials.gov listed 37 open treatment studies for retinitis pigmentosa on November 12, 2026, and 12 of them would accept a person whose vision is hand motion. Another 12 have vision rules that leave out hand motion, and 13 do not say. Only 6 of the 12 that allow hand motion list a US site.

Trial Friend built that count by reading the entry rules of every RP study that tests a treatment and is marked recruiting, not yet recruiting or enrolling by invitation. Studies that only observe patients, or that test no treatment for vision, were set aside. The retinitis pigmentosa trials page holds the live list, which changes as studies open and close. A separate page shows retinitis pigmentosa trial sites near you by distance.

Among those 6 US studies, 2 have rules that set them apart from the rest. The disulfiram study requires a diagnosis of alcohol use disorder from an addiction specialist. The stem cell study lists its phase as not applicable, has 1 treatment group and enrolls many retinal and optic nerve conditions. That leaves 4 US studies built around RP or closely related retinal diseases, namely RTx-015, BS01, OpCT-001 and DSP-3077. OpCT-001 requires a confirmed genetic diagnosis, so it is not open to someone whose testing found no cause.

RTx-015 is the largest of the 4 by number of sites. Its record lists 14 US sites, a target of 60 participants and a comparison group that gets a pretend injection. It accepts vision from about 20/200 down to 20/9000, which reaches better vision than RESTORE tested. The sponsor estimates it will finish collecting data for its main measure in October 2028.

Gene-specific studies make up a minority of the count. Only 9 of the 37 studies require a specific gene, and just 1 of those is open to a new US patient. That study, of a tablet called OCT-980 for RHO gene changes, requires more than 55 letters on an eye chart.

Why the Order of Retinitis Pigmentosa Treatments and Trials Matters

Many studies will not take someone who has already had a gene therapy. Of the 37 open RP treatment studies, 12 exclude people with a prior gene therapy. That group includes RTx-015, BS01 and OpCT-001, which are 3 of those 4 US studies, and it includes OCT-980. The fourth option, DSP-3077, excludes several kinds of earlier gene and cell therapy.

The rule ran the other way in Mogenry's own trial. RESTORE excluded anyone who had received a gene therapy, a stem cell therapy or a retinal implant. Whether an approved Mogenry label would carry a similar limit is unknown, because no proposed label is public.

Mogenry is itself a gene therapy, carried into the eye by a virus. A person treated with it would likely fall under the prior gene therapy exclusions that RTx-015, BS01, OpCT-001 and OCT-980 list. That reading comes from the published entry rules, and neither Nanoscope nor the other sponsors have said how they would handle it. RTx-015's record words its rule to cover a gene therapy in either eye.

The same care applies to the claim that no genetic test is needed. Nanoscope lists that as an advantage, and for getting Mogenry itself it may prove true. RESTORE's own entry rules still named genetic testing as part of confirming the diagnosis. Across the 37 open studies, 14 cannot be entered without a genetic result.

“I'm a big proponent of genetic testing for inherited retinal disease patients”

Christine Kay, MD, retina specialist who presented Mogenry's 4-year data, Modern Retina on OphthalmologyTimes.com, September 24, 2026

MedlinePlus says testing finds a genetic cause in 50-80% of people with RP. A result opens the gene-specific studies and, if RPE65 is involved, Luxturna. No result closes those doors and leaves the any-gene options, which is where the woman in the first example stands.

Mogenry's Price, a Second Eye and the Label Wording Are Still Unknown

No price for Mogenry has been announced by Nanoscope so far. The Institute for Clinical and Economic Review calculated in May 2025 that a fair price would fall between $67,400 and $101,300 for one eye. That is the institute's benchmark from the evidence it reviewed and not a figure from the company. The benchmark assumes that the benefit of treatment lasts for 5 years.

RESTORE treated one eye per person, the one with worse vision. The institute's report says the benefit of treating both eyes is unknown. No announcement says whether a second eye could be treated later, or whether an insurer would pay for it.

The largest open item is a single phrase. The application asks for approval in RP "with severe vision loss," and no public document turns that phrase into a number. Kay has suggested 20/200 or worse as the group most likely to gain, while RESTORE tested only vision worse than 20/1600. Where the FDA draws that line, if it approves Mogenry at all, will decide whether the retired teacher in the third example qualifies.

Two dated items will fill in more of the picture. The long-term follow-up of RESTORE's treated patients is due to finish in September 2027, by the sponsor's estimate. A free alert on the decision page goes out the day the FDA acts, with the label's wording on who qualifies.

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